Composition for regulating protein gastric emptying, fluid nutritional composition and composition
Patent Information
- Application Number
- JP2023133086
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-08-17
- Publication Date
- 2025-02-28
AI Technical Summary
【0007】 本発明により、たんぱく質の胃排出を調整することができる。例えば、本発明により、たんぱく質の胃排出を促進することができ、又は、抑制することができる。たんぱく質の胃排出促進は、例えば筋肉合成の促進又はインクレチン分泌促進のために有用である。また、たんぱく質の胃排出抑制は、例えば腎臓負担軽減又は満腹感持続のために有用である。このように、たんぱく質の胃排出を調整することによって、たんぱく質の利用特性を調整することができ、これにより種々のユーザに対して状態又はニーズに対応した栄養供給が可能となる。 なお、本発明の効果は、ここに記載された効果に限定されず、本明細書内に記載されたいずれかの効果であってもよい。本明細書において百分率は特に断りのない限り質量による表示である。
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Abstract
Description
[Technical field]
[0001] The present invention relates to protein gastric emptying modulating compositions, fluid nutritional compositions and compositions, particularly those containing agar, carrageenan or both. [Background technology]
[0002] The gastric emptying rate of nutrients can affect, for example, the duration of satiety and can also affect blood glucose levels. For this reason, several proposals have been made to regulate the gastric emptying rate.
[0003] For example, Patent Document 1 discloses "a gastric emptying rate inhibitor containing modified defatted soybeans as an active ingredient, the modified defatted soybeans having a water-soluble nitrogen index (NSI) of 7.0 to 30.0 and a settled volume in water (SV) of 7.0 mL / g or more." [Prior art documents] [Patent documents]
[0004] [Patent Document 1] Patent Publication No. 2021-29198 Summary of the Invention [Problem to be solved by the invention]
[0005] If it is possible to adjust the utilization characteristics of nutritional components, it is possible to provide a nutritional composition according to the condition or needs of each user, which is considered to be very useful. Protein is one of the important nutritional components. In order to adjust the utilization characteristics of protein, it is considered to adjust the gastric emptying of protein. Therefore, the present invention aims to provide a technology for adjusting the gastric emptying of protein. [Means for solving the problem]
[0006] The present inventors have found that certain compositions can modulate gastric emptying of proteins. That is, the present invention provides the following: <1> A protein gastric emptying regulating composition comprising agar, carrageenan, or both. <2> The composition further comprises a protein. <1> A composition for regulating protein gastric emptying as described above. <3> The total protein content is 0.1% by mass to 20% by mass based on the total mass of the protein composition for regulating gastric emptying. <1> or <2> A composition for regulating protein gastric emptying as described above. <4> The total content of agar and carrageenan is 0.01% by mass or more based on the total mass of the protein composition for regulating gastric emptying. <1> ~ <3> 2. A composition for regulating protein gastric emptying described in any one of the above. <5> The composition is a flowable composition having a viscosity that allows spontaneous dripping. <1> ~ <4> 2. A composition for regulating protein gastric emptying described in any one of the above. <6> The composition comprises agar, and The composition is a composition for promoting gastric emptying of protein. <1> ~ <5> 2. A composition for regulating protein gastric emptying described in any one of the above. <7> The composition is a composition for promoting muscle synthesis and / or incretin secretion. <6> A composition for regulating protein gastric emptying as described above. <8> The composition comprises carrageenan and The composition is a composition for inhibiting gastric emptying of protein. <1> ~ <5> 2. A composition for regulating protein gastric emptying described in any one of the above. <9> The composition is a composition for reducing kidney burden and / or maintaining satiety. <8> A protein composition for regulating gastric emptying as described above. <10> Agar, carrageenan, or both; It contains protein and gastric emptying of the protein is modulated by the agar, carrageenan, or both; Fluid nutritional composition. <11> The content of the protein relative to the total mass of the composition is 0.1% by mass to 20% by mass, The total content of the agar, carrageenan, or both of them relative to the total mass of the composition is 0.01% by mass or more; <10> The fluid nutritional composition according to claim 1. <12> A composition comprising agar, the composition being at least one selected from the group consisting of a composition for promoting muscle synthesis and a composition for promoting incretin secretion. <13> A composition comprising carrageenan, the composition being at least one selected from the group consisting of a composition for reducing kidney burden and a composition for maintaining satiety. Effect of the Invention
[0007] The present invention can adjust the gastric emptying of protein. For example, the present invention can promote or inhibit the gastric emptying of protein. Promotion of gastric emptying of protein is useful, for example, for promoting muscle synthesis or promoting incretin secretion. Inhibition of gastric emptying of protein is useful, for example, for reducing kidney burden or maintaining a feeling of fullness. In this way, by adjusting the gastric emptying of protein, the utilization characteristics of protein can be adjusted, which enables nutritional supply to various users according to their conditions or needs. The effects of the present invention are not limited to those described herein, and may be any of the effects described in this specification. In this specification, percentages are expressed by mass unless otherwise specified. [Brief description of the drawings]
[0008] [Figure 1A] FIG. 2 is a schematic diagram for explaining a digestion process. [Figure 1B] 1 is a photograph of a composition sample. [Figure 2A] 1 is a graph showing the measurement results of protein concentration. [Figure 2B] 1 is a graph showing the results of measuring carbohydrate concentrations. [Figure 2C]1 is a graph showing the ratio of carbohydrate concentration / protein concentration. [Figure 2D] This is the pH measurement result. [Figure 3A] 1 is a graph showing the measurement results of protein concentration. [Figure 3B] 1 is a graph showing the results of measuring carbohydrate concentrations. [Figure 3C] 1 is a graph showing the ratio of carbohydrate concentration / protein concentration. [Figure 3D] This is the pH measurement result. [Figure 4A] 1 is a graph showing the measurement results of protein concentration. [Figure 4B] 1 is a graph showing the results of measuring carbohydrate concentrations. [Figure 4C] 1 is a graph showing the ratio of carbohydrate concentration / protein concentration. [Figure 4D] This is the pH measurement result. [Figure 5A] 1 is a graph showing the measurement results of protein concentration. [Figure 5B] 1 is a graph showing the results of measuring carbohydrate concentrations. [Figure 5C] 1 is a graph showing the ratio of carbohydrate concentration / protein concentration. [Figure 5D] This is the pH measurement result. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0009] The following describes preferred embodiments of the present invention. However, the present invention is not limited to the following preferred embodiments and can be freely modified within the scope of the present invention.
[0010] The composition of the present invention contains agar, carrageenan, or both. These ingredients are useful for adjusting the gastric emptying of proteins. For example, agar is very useful as an active ingredient for promoting the gastric emptying of proteins. Also, carrageenan is very useful as an active ingredient for inhibiting the gastric emptying of proteins. According to the present invention, the gastric emptying of proteins is adjusted by these ingredients.
[0011] In one embodiment, the composition of the present invention may be a composition for regulating protein gastric emptying, i.e., the present invention provides a composition for regulating protein gastric emptying, comprising agar, carrageenan, or both. The gastric emptying regulation may be, for example, the promotion of gastric emptying of proteins, in which case the composition comprises at least agar. The gastric emptying regulation may also be, for example, inhibition of gastric emptying of protein, in which case the composition contains at least carrageenan.
[0012] In another embodiment, the composition of the present invention may be a fluid nutritional composition. That is, the present invention also provides a fluid nutritional composition containing agar, carrageenan, or both. The fluid nutritional composition may further contain a protein, and the gastric emptying of the protein may be regulated by the agar, carrageenan, or both. In this embodiment, the gastric emptying regulation may be, for example, the promotion of gastric emptying of proteins, in which case the composition comprises at least agar. The gastric emptying regulation may also be, for example, inhibition of gastric emptying of protein, in which case the composition contains at least carrageenan.
[0013] As described above, agar is useful as an active ingredient for promoting gastric emptying of proteins. The promotion of gastric emptying leads to a promotion effect of muscle synthesis or incretin secretion. That is, the present invention also provides a composition containing agar, which is at least one composition selected from the group consisting of a composition for promoting muscle synthesis and a composition for promoting incretin secretion.
[0014] As described above, carrageenan is useful as an active ingredient for suppressing gastric emptying of protein. The suppression of gastric emptying brings about an effect of reducing the burden on the kidneys or an effect of maintaining a feeling of fullness. That is, the present invention also provides a composition containing carrageenan, which is at least one selected from the group consisting of a composition for reducing the burden on the kidneys and a composition for maintaining a feeling of fullness.
[0015] The various compositions according to the invention will now be described in more detail. In addition, the symbol "~" used in the present specification for a range of values includes the values before and after as the lower limit and upper limit, respectively.
[0016] 1. Agar, carrageenan 2. Protein 3. Carbohydrates 4. Lipids 5. Other Ingredients 6. Physical properties of the composition 7. Manufacturing method 8.How to use 9. Food and drink composition 10. Pharmaceutical Compositions 11. Example of nutritional composition 12. Other embodiments of the present invention 13. Working Example
[0017] 1. Agar, carrageenan
[0018] 1.1 Agar In one embodiment, the composition according to the present invention contains agar. The agar has an effect of promoting gastric emptying of protein. The agar may be, for example, a polysaccharide having agarose and agaropectin as components. The agar may be, for example, one obtained from red algae such as Gelidium or Oligonori. As the agar, agar known in the art may be used, and the type of agar may be selected depending on, for example, the physical properties (particularly viscosity) required for the composition, or the content of agar may be adjusted.
[0019] The agar has a jelly strength of, for example, 1000 g / cm 2 The agar may have a jelly strength of 800 g / cm or less. 2 Less than 600g / cm 2 Less than 500 g / cm 2 Below, 450g / cm 2 Below 400g / cm 2 or less than 350g / cm 2 It may be less than 0.1. It is considered that the low jelly strength of agar contributes to more effectively exerting the gastric emptying promoting effect of protein. In addition, agar with a low jelly strength is also suitable for using the composition of the present invention in the form of a flowable composition such as an enteral nutritional agent. That is, in one embodiment, the composition of the present invention may be a flowable composition containing agar having such a jelly strength, such as an enteral nutritional agent. In addition, the composition of the present invention does not have to be a composition used as parenteral nutrition. The lower limit of the jelly strength of the agar is not particularly limited, but the jelly strength is, for example, 50 g / cm 2 More than 100g / cm 2 or more, and 2 It may be more than that.
[0020] The jelly strength of agar is a value measured by the Nihon Kansui method. In other words, the jelly strength is a value measured using a Nihon Kansui method jelly strength measuring device adopted by the Japan Agar Manufacturing Fisheries Association. An agar solution with a concentration of 1.5% by mass was prepared, left at 20°C for 15 hours to solidify the gel, and the jelly strength was measured on the surface of 1 cm 2 The maximum load (g) that can be withstood for 20 seconds per 2 The jelly strength was measured using a rheometer (manufactured by Rheotech, 1 cm 2 A plunger and sample stage raising speed of 2 cm / min may be used.
[0021] The agar may have a weight-average molecular weight of, for example, 500,000 or less, and preferably, the weight-average molecular weight of the agar may be 400,000 or less, more preferably 300,000 or less, even more preferably 250,000 or less, 200,000 or less, or 150,000 or less. It is considered that the low weight-average molecular weight of agar contributes to more effectively exerting the gastric emptying promoting effect of protein. In addition, such agar with a low weight-average molecular weight is also suitable for using the composition of the present invention in the form of, for example, a fluid enteral nutrient. The lower limit of the weight average molecular weight of the agar is not particularly limited, but the weight average molecular weight is, for example, 10,000 or more, may be 30,000 or more, or may be 50,000 or more. The weight average molecular weight of agar is measured by the GPC method.
[0022] The content of agar relative to the total mass of the composition of the present invention is, for example, 0.01% by mass or more, preferably 0.03% by mass or more, more preferably 0.05% by mass or more. In some embodiments, the content may be 0.10% by mass or more, 0.15% by mass or more, 0.20% by mass or more, 0.30% by mass or more, or 0.50% by mass or more. It is believed that the inclusion of agar in such a content ratio contributes to more effectively exerting the gastric emptying promoting effect of protein. The content of agar relative to the total mass of the composition of the present invention may be, for example, 3% by mass or less, preferably 2% by mass or less, more preferably 1% by mass or less. In some embodiments, the content may be 0.80% by mass or less, or even 0.50% by mass or less. For example, in order to impart fluidity to the composition, it is desirable that the agar content be at a relatively low value. The range of the content of agar relative to the total mass of the composition for promoting gastric emptying of protein may be determined by a value selected from these upper and lower limits, and the content of agar may be, for example, 0.01% to 3% by mass, 0.03% to 2% by mass, 0.05% to 1% by mass, or 0.10% to 0.80% by mass. In some embodiments, the content may be, for example, 0.10% to 0.50% by mass. The above agar content may be applied when the composition of the present invention contains agar but does not contain carrageenan. The above agar content may also be applied when the composition of the present invention contains both agar and carrageenan, but in this case, the content of agar may be appropriately set low from the viewpoint of fluidity and the required protein gastric emptying regulating effect.
[0023] In the composition of the present invention, (total agar content) / (total protein content contained in the composition) may be, for example, 0.001 or more, preferably 0.01 or more, and more preferably 0.02 or more. It is believed that such a ratio of (total agar content) / (total protein content contained in the composition) contributes to more effectively exerting the gastric emptying promoting effect of protein. In the composition of the present invention, (total agar content) / (total protein content contained in the composition) may be, for example, 0.5 or less, preferably 0.4 or less, and more preferably 0.3 or less. For example, from the viewpoint of the flowability of the composition of the present invention, it is desirable that the ratio is equal to or less than such an upper limit. The numerical range of the ratio may be defined by values selected from these upper and lower limits, respectively, and the ratio may be, for example, 0.001 to 0.5, 0.01 to 0.4, or 0.02 to 0.3. The numerical ranges of the ratios described above may apply, for example, when the composition of the present invention contains agar but not carrageenan, but may also apply when the composition of the present invention contains both agar and carrageenan.
[0024] 1.2 Carrageenan In another embodiment, the composition of the present invention contains carrageenan. The carrageenan has a protein gastric emptying inhibitory effect. The carrageenan may be one or a combination of two or more of iota carrageenan, kappa carrageenan, and lambda carrageenan. The type of the carrageenan is not particularly limited, but it is considered that the carrageenan being iota carrageenan contributes to more effectively exerting the protein gastric emptying inhibitory effect. That is, in a preferred embodiment, the composition of the present invention may contain at least iota carrageenan. The carrageenan contained in the composition of the present invention may be, for example, the carrageenan with the highest content of iota carrageenan among these three types of carrageenan. Iota carrageenan is a carrageenan having a structural unit (also referred to as "iota carrageenan unit" in this specification) in which two sulfate groups are attached to a structure in which two galactose groups are bonded as a representative structural unit. Iota carrageenan may have other carrageenan units as subcomponents in addition to the iota carrageenan units, for example, may have kappa carrageenan units in addition to the iota carrageenan units. As iota carrageenan, commercially available ita carrageenan preparations may be used. Kappa carrageenan is a carrageenan having a structural unit (also referred to as "kappa carrageenan unit" in this specification) in which one sulfate group is attached to a structure in which two galactose groups are bonded as a representative structural unit. Kappa carrageenan may have other carrageenan units as minor components in addition to the kappa carrageenan units, for example, may have iota carrageenan units in addition to the kappa carrageenan units. Commercially available kappa carrageenan preparations may be used as kappa carrageenan. Lambda carrageenan is a carrageenan having a structural unit (also referred to as "lambda carrageenan unit" in this specification) in which two galactose groups are bonded to a structure in which three sulfate groups are attached as a representative structural unit. In addition to the lambda carrageenan unit, the lambda carrageenan may have other carrageenan units as subcomponents. As the lambda carrageenan, a commercially available lambda carrageenan preparation may be used. As the carrageenan, any carrageenan known in the art may be used, and the type of carrageenan may be selected depending on, for example, the physical properties (particularly viscosity) required for the composition, or the carrageenan content may be adjusted.
[0025] The carrageenan has a jelly strength of, for example, 10 N / cm 2 Preferably, the carrageenan has a jelly strength of 5 N / cm or less. 2 Less than or equal to 3N / cm 2 Less than or equal to 1 N / cm 2 Below, 0.8N / cm 2 or less than 0.5N / cm 2 It may be the following: The jelly strength of the carrageenan is, for example, 0.01 N / cm 2 More than 0.05N / cm 2 It may be more than that. Carrageenan having such a jelly strength is suitable for exerting the gastric emptying inhibitory effect of proteins according to the present invention. The jelly strength of carrageenan is measured by dissolving carrageenan in water at a concentration of 3% (w / w) at 80°C, gelling the resulting carrageenan aqueous solution, and measuring the gel obtained at 8°C using a rheometer (COMPAC-100 made by Sun Scientific, compression speed 60 mm / min, pressure-sensitive cylindrical shaft 11.3 mm, load when compressed by 4 mm).
[0026] The mass proportion of sulfate groups in the carrageenan may be, for example, 15% or more, particularly 20% or more, more particularly 22% or more, and more particularly 24% or more. The mass proportion of sulfate groups in the carrageenan may be, for example, 35% or less, particularly 30% or less, and more particularly 28% or less. The mass ratio of the sulfate group may be measured according to the method described in Food Hygiene Journal, Vol. 35, No. 6, pp. 631-635, 1994, in particular, vacuum type ICP emission spectrometry.
[0027] The carrageenan may have a viscosity, when dissolved in water at a concentration of 1% (w / w), of, for example, 1000 mPa·s or less, preferably 800 mPa·s or less, and more preferably 600 mPa·s or less. The viscosity of the carrageenan may be, for example, 3 mPa·s or more, preferably 5 mPa·s or more, hi some embodiments, the viscosity may be, for example, 30 mPa·s or more, or 50 mPa·s or more. Carrageenan exhibiting such a viscosity is suitable for exhibiting the gastric emptying inhibitory effect of proteins according to the present invention. To measure the viscosity, carrageenan is dissolved in water to a concentration of 1% (w / w) at 80° C. The viscosity of the resulting aqueous carrageenan solution is measured at 20° C. using a B-type viscometer with rotor No. 2 at 60 rpm. In this way, the viscosity is measured.
[0028] The content of carrageenan relative to the total mass of the composition of the present invention is, for example, 0.01% by mass or more, preferably 0.03% by mass or more, more preferably 0.05% by mass or more. In some embodiments, the content may be 0.10% by mass or more, 0.15% by mass or more, 0.20% by mass or more, 0.30% by mass or more, or 0.50% by mass or more. It is believed that including carrageenan at such a content ratio contributes to more effectively exerting the gastric emptying inhibitory effect of protein. The content of carrageenan relative to the total weight of the composition of the present invention may be, for example, 3% by weight or less, preferably 2% by weight or less, more preferably 1% by weight or less. In some embodiments, the content may be 0.80% by weight or less, or even 0.50% by weight or less. For example, in order to impart fluidity to the composition, the content is desirably at a relatively low value. The range of the content of carrageenan relative to the total mass of the composition for inhibiting gastric emptying of protein may be determined by a value selected from these upper and lower limits, and the content of carrageenan may be, for example, 0.01% to 3% by mass, 0.03% to 2% by mass, 0.05% to 1% by mass, or 0.10% to 0.80% by mass. In some embodiments, the content may be, for example, 0.10% to 0.50% by mass. The above carrageenan content may be applied when the composition of the present invention contains carrageenan but does not contain agar. The above carrageenan content may also be applied when the composition of the present invention contains both carrageenan and agar, but in this case, the content of carrageenan may be appropriately reduced from the viewpoint of fluidity and the required protein gastric emptying regulating effect.
[0029] In the composition of the present invention, (total carrageenan content) / (total protein content contained in the composition) may be, for example, 0.001 or more, preferably 0.01 or more, and more preferably 0.02 or more. It is believed that such a ratio of (total carrageenan content) / (total protein content contained in the composition) contributes to more effectively exerting the gastric emptying inhibitory effect of protein. In the composition of the present invention, (total carrageenan content) / (total protein content contained in the composition) may be, for example, 0.5 or less, preferably 0.4 or less, and more preferably 0.3 or less. For example, from the viewpoint of the flowability of the composition of the present invention, it is desirable that the ratio is equal to or less than such an upper limit. The numerical range of the ratio may be defined by values selected from these upper and lower limits, respectively, and the ratio may be, for example, 0.001 to 0.5, 0.01 to 0.4, or 0.02 to 0.3. The numerical ranges of ratios described above may apply, for example, when the composition of the present invention contains carrageenan but not agar, but may also apply when the composition of the present invention contains both agar and carrageenan.
[0030] 1.3 Effects of agar and carrageenan As described above, in one embodiment of the present invention, the composition of the present invention includes agar. In this embodiment, the composition may be a composition for promoting gastric emptying of protein. The gastric emptying promoting effect of the composition (particularly the agar) may mean, for example, that the protein present in the stomach is promoted to be discharged from the pylorus of the stomach to the outside of the stomach (particularly to the duodenum). The presence or absence of the promoting effect may be evaluated, for example, based on the protein concentration measured by the evaluation test described in the Examples below. The gastric emptying promoting effect of the protein may be exerted 0 to 270 minutes, 0 to 216 minutes, 0 to 162 minutes, or 0 to 108 minutes after ingestion of the composition. In this embodiment, the composition may be configured to include at least agar. Also, in this embodiment, the composition may be configured to include agar but not include carrageenan.
[0031] As described above, in another embodiment of the present invention, the composition of the present invention contains carrageenan. In this embodiment, the composition may be a composition for inhibiting gastric emptying of protein. The gastric emptying inhibitory effect of the composition (particularly the carrageenan) may mean, for example, that the protein present in the stomach is inhibited from being discharged from the pylorus of the stomach to the outside of the stomach (particularly to the duodenum). The presence or absence of the inhibitory effect may be evaluated, for example, based on the protein concentration measured by the evaluation test described in the Examples below. The gastric emptying inhibitory effect of the protein may be exerted 0 to 270 minutes, 0 to 216 minutes, 0 to 162 minutes, or 0 to 108 minutes after ingestion of the composition. In this embodiment, the composition may be configured to include at least carrageenan. Also, in this embodiment, the composition may be configured to include carrageenan but not include agar.
[0032] In some embodiments of the present invention, the composition of the present invention may be a composition containing both agar and carrageenan. In this embodiment, the composition may be configured as a composition for adjusting gastric emptying of protein, for example, a composition for promoting gastric emptying of protein or a composition for inhibiting gastric emptying of protein. Whether the composition promotes or inhibits gastric emptying of protein may be selected depending on, for example, the content ratio of agar and carrageenan. In addition, when the content ratios of these are approximately the same, the gastric emptying promoting effect of agar may take precedence over the gastric emptying inhibitory effect of carrageenan. That is, the composition of the present invention may contain both agar and carrageenan, and in this case, the composition may be a composition for promoting gastric emptying of protein.
[0033] In the composition of the present invention, the total content of agar and carrageenan is, for example, 0.01% by mass or more, preferably 0.03% by mass or more, more preferably 0.05% by mass or more, based on the total mass of the protein composition for regulating gastric emptying. In some embodiments, the content may be 0.10% by mass or more, 0.15% by mass or more, 0.30% by mass or more, or even 0.50% by mass or more. It is believed that the inclusion of agar and / or carrageenan in such a content ratio contributes to more effectively exerting the gastric emptying regulating effect of protein. The total content of agar and carrageenan relative to the total mass of the composition of the present invention may be, for example, 3% by mass or less, preferably 2% by mass or less, more preferably 1% by mass or less. In some embodiments, the content may be 0.80% by mass or less, or even 0.50% by mass or less. For example, in order to impart fluidity to the composition, the content is desirably at a relatively low value. The range of the total content of agar and carrageenan relative to the total mass of the protein composition for regulating gastric emptying may be determined by a value selected from these upper and lower limits, and the content may be, for example, 0.01% to 3% by mass, 0.03% to 2% by mass, 0.05% to 1% by mass, or 0.10% to 0.80% by mass. In some embodiments, the content may be, for example, 0.10% to 0.50% by mass.
[0034] In the composition of the present invention, (total content of agar and carrageenan) / (total content of protein contained in the composition) may be, for example, 0.001 or more, preferably 0.01 or more, preferably 0.02 or more, preferably 0.03 or more, more preferably 0.04 or more, and even more preferably 0.05 or more. It is believed that such a ratio of (total content of agar and carrageenan) / (total content of protein contained in the composition) contributes to more effectively exerting the protein gastric emptying regulating effect. In the composition of the present invention, (total content of agar and carrageenan) / (total content of protein contained in the composition) may be, for example, 0.5 or less, preferably 0.4 or less, and more preferably 0.3 or less. For example, from the viewpoint of the flowability of the composition of the present invention, it is desirable that the ratio is equal to or less than such an upper limit. The numerical range of the ratio may be defined by values selected from these upper and lower limits, respectively, and the ratio may be, for example, 0.001 to 0.5, 0.01 to 0.4, or 0.02 to 0.3.
[0035] 2. Protein The composition of the present invention may further comprise a protein. The composition of the present invention may be configured such that the gastric emptying of the protein contained in the composition is regulated by the agar and / or carrageenan contained in the composition. As used herein, the term "protein" is intended to encompass intact proteins as well as proteolytic degradation products, such as peptides.
[0036] The protein may be an animal protein or a vegetable protein, or a combination thereof. The animal protein may, for example, comprise one or more of milk protein, egg protein, and collagen. In a preferred embodiment, the composition comprises a milk protein. The milk protein may in particular be casein, whey protein, or both. The vegetable protein may be, for example, soy protein, rice protein, or wheat protein. In a preferred embodiment, the composition comprises soy protein.
[0037] The raw material used to provide the protein to the composition (also referred to as the protein raw material) may be appropriately selected by a person skilled in the art. For example, when the protein is a milk protein, a milk raw material described later may be used as the protein raw material to add the milk protein to the composition.
[0038] The total protein content in the composition may be, for example, 0.1% by mass or more, preferably 0.5% by mass or more, more preferably 1.0% by mass or more, and even more preferably 1.5% by mass or more, 2.0% by mass or more, 2.5% by mass or more, or 3.0% by mass or more, relative to the total mass of the composition (particularly the composition for promoting protein gastric emptying or the composition for inhibiting protein gastric emptying). Such a content ratio enables the composition to provide efficient protein supplementation. As used herein, the term "total protein content" refers to the total protein content contained in the composition of the present invention, i.e., may refer to the total content of undegraded protein and protein digests. The total protein content in the composition may be, for example, 20% by mass or less, preferably 15% by mass or less, more preferably 10% by mass or less, and even more preferably 8.0% by mass or less, 7.0% by mass or less, 6.0% by mass or less, or 5.0% by mass or less, relative to the total mass of the composition. The numerical range of the total protein content relative to the total mass of the composition may be defined by a value selected from these upper and lower limits, and the content may be, for example, 0.1% by mass to 20% by mass, 0.5% by mass to 15% by mass, or 1.0% by mass to 10% by mass.
[0039] The total protein content can be calculated by adding up the mass of protein from the raw materials contained in 100 g of the composition. If such calculation is not possible, the total protein content can be measured by the Kjeldahl method.
[0040] In a preferred embodiment, the protein comprises a milk protein or / and a milk protein hydrolysate. The milk protein may be casein, a casein hydrolysate, a whey protein, a whey protein hydrolysate, or a combination of two or more thereof. The casein hydrolysate may be, for example, a casein peptide. The whey protein hydrolysate may be a whey protein peptide.
[0041] The dairy protein may be provided to the composition, for example, by a dairy ingredient. For example, the milk protein may be provided to the composition by incorporating a caseinate such as sodium caseinate or calcium caseinate, acid casein, a micellar casein concentrate (e.g., MCC (Micellar Casein Concentrate) and MCI (Micellar Casein Isolate)), or a milk protein concentrate (e.g., MPC (Milk Protein Concentrate) and MPI (Milk Protein Isolate)), or skim milk powder into the composition. The milk protein may also be provided to the composition by incorporating a whey protein concentrate (WPC), whey protein isolate (WPI), or whey powder into the composition. That is, the composition may include one or a combination of two or more of these dairy ingredients.
[0042] 3. Carbohydrates As described above, the composition of the present invention contains agar and / or carrageenan, which are so-called dietary fibers and also carbohydrates. The composition of the present invention may further contain carbohydrates other than agar and carrageenan. Carbohydrates are roughly divided into sugars and dietary fibers. Sugars are carbohydrates that can be digested by human digestive enzymes, and are also called easily digestible carbohydrates. Meanwhile, dietary fibers are carbohydrates that cannot be digested by human digestive enzymes, and are also called indigestible carbohydrates.
[0043] The composition of the present invention contains agar and / or carrageenan as described above, i.e., contains at least dietary fiber. The composition of the present invention may contain dietary fiber other than agar and carrageenan. Examples of the dietary fiber include, for example, resistant dextrin, cellulose, guar gum, guar gum hydrolyzate, inulin, pectin, alginic acid, polydextrose, β-glucan, gellan gum, xanthan gum, fermented cellulose, and resistant oligosaccharides. Examples of the resistant oligosaccharides include lactulose, raffinose, and human milk oligosaccharides. Examples of the human milk oligosaccharides include 2'-fucosyllactose, 3'-fucosyllactose, lacto-N-fucopentaose I, lacto-N-difucohexaose I, lacto-N-tetraose, and lacto-N-neotetraose. The composition of the present invention may further contain one or a combination of two or more selected from these in addition to agar and / or carrageenan.
[0044] The composition of the present invention may contain carbohydrates in addition to dietary fiber. In order to efficiently supply energy to humans using the composition of the present invention, the composition of the present invention may preferably contain both dietary fiber (particularly agar and / or carrageenan) and carbohydrates.
[0045] The carbohydrates include those belonging to monosaccharides, disaccharides, sugar alcohols, oligosaccharides, or polysaccharides, and one or a combination of two or more of these may be included in the composition of the present invention as the carbohydrates. The monosaccharides include, for example, fructose, glucose, and galactose. The disaccharides include, for example, sucrose, maltose, and lactose. Examples of the sugar alcohols include sorbitol, mannitol, and maltitol. Examples of the oligosaccharides include fructooligosaccharides, galactooligosaccharides, xylooligosaccharides, etc. Examples of the polysaccharides include starch and starch hydrolysates. The compositions of the invention may include one or a combination of two or more of these carbohydrates.
[0046] The total carbohydrate content in the composition may be, for example, 0.1% by mass or more, preferably 1.0% by mass or more, more preferably 2.0% by mass or more, and even more preferably 3.0% by mass or more, 5.0% by mass or more, 7.0% by mass or more, 8.0% by mass or more, 10.0% by mass or more, or 12.0% by mass or more, relative to the total mass of the composition (particularly the composition for promoting protein gastric emptying or the composition for inhibiting protein gastric emptying). With such a content ratio, the composition of the present invention can efficiently supply energy to humans. As used herein, the term "total carbohydrate content" refers to the total carbohydrate content contained in the composition of the present invention, that is, it may refer to the total content of dietary fiber and sugars. The total carbohydrate content in the composition may be, for example, 40% by weight or less, preferably 30% by weight or less, more preferably 25% by weight or less, and even more preferably 24% by weight or less, 22% by weight or less, 20% by weight or less, or 18% by weight or less, relative to the total weight of the composition. The numerical range of the total carbohydrate content relative to the total mass of the composition may be defined by a value selected from these upper and lower limits, and the content may be, for example, 0.1% to 40% by mass, 1.0% to 30% by mass, or 2.0% to 25% by mass.
[0047] The carbohydrate content in the composition may be, for example, 0.1% by mass or more, preferably 1.0% by mass or more, more preferably 2.0% by mass or more, and even more preferably 3.0% by mass or more, 5.0% by mass or more, 7.0% by mass or more, 8.0% by mass or more, or 10.0% by mass or more, relative to the total mass of the composition (particularly the composition for promoting protein gastric emptying or the composition for inhibiting protein gastric emptying). With such a content ratio, the composition of the present invention can efficiently supply energy to humans. As used herein, the term "carbohydrate content" refers to the total carbohydrate content contained in the composition of the present invention. The carbohydrate content in the composition may be, for example, 40% by mass or less, preferably 30% by mass or less, more preferably 25% by mass or less, and even more preferably 24% by mass or less, 22% by mass or less, 20% by mass or less, 18% by mass or less, or 16% by mass or less, relative to the total mass of the composition. The numerical range of the carbohydrate content relative to the total mass of the composition may be defined by a value selected from these upper and lower limits, respectively, and the content may be, for example, 0.1% by mass to 40% by mass, 1.0% by mass to 30% by mass, or 2.0% by mass to 25% by mass.
[0048] The dietary fiber content in the composition may be, for example, 0.01% by mass or more, preferably 0.03% by mass or more, 0.05% by mass or more, 0.07% by mass or more, 0.1% by mass or more, 0.2% by mass or more, 0.3% by mass or more, 0.5% by mass or more, or 1.0% by mass or more, relative to the total mass of the composition (particularly the composition for promoting protein gastric emptying or the composition for inhibiting protein gastric emptying). With such a content ratio, the composition of the present invention can be expected to have beneficial effects on human health, such as intestinal regulation, mineral absorption promotion, and prevention and improvement of inflammatory bowel disease. As used herein, the term "dietary fiber content" refers to the total dietary fiber content contained in the composition of the present invention. The dietary fiber content in the composition may be, for example, 40% by mass or less, 30% by mass or less, 25% by mass or less, 10% by mass or less, 5.0% by mass or less, 4.0% by mass or less, 3.0% by mass or less, or 2.0% by mass or less, relative to the total mass of the composition. The numerical range of the carbohydrate content relative to the total mass of the composition may be defined by a value selected from these upper and lower limits, and the content may be, for example, 0.1% by mass to 40% by mass, 0.5% by mass to 30% by mass, or 1.0% by mass to 20% by mass.
[0049] 4. Lipids The composition of the present invention may further contain lipid. The lipid may be any oil or fat used in food, such as vegetable oils such as soybean oil, rapeseed oil, corn oil, and animal oils such as fish oil, without any particular limitation. For example, the composition of the present invention may contain vegetable oil as the lipid, or may contain fish oil, or may contain both vegetable oil and fish oil. In some embodiments, the composition of the present invention may further contain medium chain triglyceride (hereinafter also referred to as MCT) as the lipid. Additionally, in some embodiments of the present invention, the composition may be lipid-free.
[0050] The total lipid content in the composition may be, for example, 0.01% by mass or more, preferably 0.5% by mass or more, more preferably 1.0% by mass or more, 1.3% by mass or more, 1.5% by mass or more, 1.7% by mass or more, or 2.0% by mass or more, relative to the total mass of the composition (particularly the composition for promoting protein gastric emptying or the composition for inhibiting protein gastric emptying). With such a content ratio, the composition of the present invention can efficiently supply energy to humans. As used herein, the term "total lipid content" refers to the total lipid content contained in the composition of the present invention. The total lipid content in the composition may be, for example, 10% by mass or less, preferably 8% by mass or less, more preferably 6% by mass or less, 5.0% by mass or less, or 4.0% by mass or less, relative to the total mass of the composition. The numerical range of the total lipid content relative to the total mass of the composition may be defined by a value selected from these upper and lower limits, and the content may be, for example, 0.01% by mass to 10% by mass, 0.5% by mass to 8% by mass, or 1.0% by mass to 6% by mass.
[0051] Where the composition of the invention comprises a lipid, the composition may be formulated as an emulsion, in particular an oil-in-water emulsion.
[0052] 5. Other Ingredients The composition of the present invention may further contain components other than the components described above in (1) to (4). These components are described below.
[0053] (5-1) Minerals Examples of mineral components include sodium, potassium, calcium, magnesium, phosphorus, iron, copper, zinc, etc. By appropriately containing these minerals, the composition of the present invention can provide minerals necessary for human growth.
[0054] The composition of the present invention contains sodium preferably in an amount of 30 to 250 mg / 100 g, more preferably 43 to 240 mg / 100 g, and even more preferably 70 to 200 mg / 100 g. In addition, in the case where the composition of the present invention is contained in a food or drink described later, the content may be the sodium content per 100 kcal of the total energy of the food or drink. In other words, the above-mentioned numerical range of the content may be interpreted as the numerical range of the content per 100 kcal of the total energy of the composition (particularly the food or drink). For example, the sodium content expressed per 100 kcal of the total energy of the composition (particularly the food or drink) may be preferably 30 to 250 mg / 100 kcal, more preferably 43 to 240 mg / 100 kcal, and even more preferably 70 to 200 mg / 100 kcal. The composition of the present invention contains potassium preferably 25 to 240 mg / 100 g, more preferably 30 to 225 mg / 100 g, and even more preferably 50 to 190 mg / 100 g. In addition, when the composition of the present invention is contained in a food or drink described later, the content may be the potassium content per 100 kcal of the total energy of the food or drink. That is, the potassium content expressed per 100 kcal of the total energy of the composition (particularly the food or drink) may be preferably 25 to 240 mg / 100 kcal, more preferably 30 to 225 mg / 100 kcal, and even more preferably 50 to 190 mg / 100 kcal. The composition of the present invention contains chlorine preferably in an amount of 50 to 320 mg / 100 g, more preferably 70 to 280 mg / 100 g, and even more preferably 90 to 250 mg / 100 g. In addition, when the composition of the present invention is contained in a food or drink described later, the content may be the chlorine content per 100 kcal of the total energy of the food or drink. That is, the chlorine content expressed per 100 kcal of the total energy of the composition (particularly the food or drink) may be preferably 50 to 320 mg / 100 kcal, more preferably 70 to 280 mg / 100 kcal, and even more preferably 90 to 250 mg / 100 kcal. The composition of the present invention contains calcium preferably at 20 to 150 mg / 100 g, more preferably at 30 to 145 mg / 100 g, and even more preferably at 50 to 120 mg / 100 g. In addition, when the composition of the present invention is contained in a food or drink described later, the content may be the calcium content per 100 kcal of the total energy of the food or drink. That is, the calcium content expressed per 100 kcal of the total energy of the composition (particularly the food or drink) may be preferably at 20 to 150 mg / 100 kcal, more preferably at 30 to 145 mg / 100 kcal, and even more preferably at 50 to 120 mg / 100 kcal. The composition of the present invention preferably contains 5 to 150 mg / 100 g of magnesium, more preferably 10 to 100 mg / 100 g, and even more preferably 15 to 70 mg / 100 g. In addition, when the composition of the present invention is contained in a food or drink described later, the content may be the magnesium content per 100 kcal of the total energy of the food or drink. That is, the magnesium content expressed per 100 kcal of the total energy of the composition (particularly the food or drink) may be preferably 5 to 150 mg / 100 kcal, more preferably 10 to 100 mg / 100 kcal, and even more preferably 15 to 70 mg / 100 kcal. The numerical ranges of the content of each component such as phosphorus and iron described below may be interpreted as the numerical range of the content per 100 kcal of energy, similar to the above-mentioned sodium, potassium, chlorine, calcium, and magnesium. That is, the numerical ranges obtained by interpreting the unit of the numerical ranges described below as "mg / 100g" as "mg / 100 kcal" may be applied as the numerical range of the content of each component. The unit of "μg / 100g" may also be interpreted as "μg / 100 kcal". The composition of the present invention contains phosphorus in an amount of preferably 35 to 160 mg / 100 g, more preferably 35 to 145 mg / 100 g, and even more preferably 35 to 120 mg / 100 g. The composition of the present invention contains iron in an amount of preferably 0.05 to 5.0 mg / 100 g, more preferably 0.3 to 3.0 mg / 100 g, and even more preferably 0.6 to 2.0 mg / 100 g. The composition of the present invention contains zinc in an amount of preferably 0.05 to 10 mg / 100 g, more preferably 0.5 to 4.0 mg / 100 g, and even more preferably 0.8 to 2.0 mg / 100 g. The composition of the present invention contains copper in an amount of preferably 10 to 400 μg / 100 g, more preferably 30 to 300 μg / 100 g, and even more preferably 50 to 200 μg / 100 g. The composition of the present invention contains manganese in an amount of preferably 10 to 500 μg / 100 g, more preferably 50 to 350 μg / 100 g, and even more preferably 100 to 250 μg / 100 g. The composition of the present invention contains iodine in an amount of preferably 1 to 50 μg / 100 g, more preferably 5 to 30 μg / 100 g, and even more preferably 10 to 20 μg / 100 g. The composition of the present invention contains selenium in an amount of preferably 0.1 to 30 μg / 100 g, more preferably 0.5 to 15 μg / 100 g, and even more preferably 1 to 8 μg / 100 g. The composition of the present invention contains chromium in an amount of preferably 0.1 to 30 μg / 100 g, more preferably 0.5 to 15 μg / 100 g, and even more preferably 1 to 8 μg / 100 g. The composition of the present invention contains molybdenum in an amount of preferably 0.05 to 25 μg / 100 g, more preferably 0.2 to 12 μg / 100 g, and even more preferably 0.8 to 6 μg / 100 g.
[0055] (5-2) Vitamins The composition of the present invention may further contain vitamins, such as vitamin A, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, pantothenic acid, biotin, vitamin C, etc. By including such vitamins, the composition of the present invention can provide vitamins necessary for human growth.
[0056] The composition of the present invention contains vitamin A preferably in an amount of 5 to 200 μg RAE / 100 g, more preferably 20 to 180 μg RAE / 100 g, and even more preferably 50 to 150 μg RAE / 100 g. Furthermore, the composition of the present invention contains vitamin D in an amount of preferably 0.05 to 5.5 μg / 100 g, more preferably 0.1 to 4.5 μg / 100 g, and even more preferably 0.2 to 3.6 μg / 100 g. Furthermore, the composition of the present invention contains vitamin E in an amount of preferably 0.05 to 6.0 mg / 100 g, more preferably 0.2 to 4.0 mg / 100 g, and even more preferably 0.4 to 2.0 mg / 100 g. Furthermore, the composition of the present invention contains vitamin K in an amount of preferably 1.0 to 18.0 μg / 100 g, more preferably 3.0 to 13.0 μg / 100 g, and even more preferably 5.0 to 11.0 μg / 100 g. Furthermore, the composition of the present invention contains vitamin B1 in an amount of preferably 0.05 to 1.0 mg / 100 g, more preferably 0.10 to 0.7 mg / 100 g, and even more preferably 0.15 to 0.5 mg / 100 g. Furthermore, the composition of the present invention contains vitamin B2 in an amount of preferably 0.05 to 0.80 mg / 100 g, more preferably 0.10 to 0.50 mg / 100 g, and even more preferably 0.20 to 0.40 mg / 100 g. Furthermore, the composition of the present invention contains niacin in an amount of preferably 1.0 to 6.0 mg / 100 g, more preferably 2.0 to 4.5 mg / 100 g, and even more preferably 2.2 to 4.0 mg / 100 g. Furthermore, the composition of the present invention contains vitamin B6 in an amount of preferably 0.05 to 1.0 mg / 100 g, more preferably 0.10 to 0.7 mg / 100 g, and even more preferably 0.15 to 0.5 mg / 100 g. Furthermore, the composition of the present invention contains vitamin B12 in an amount of preferably 0.10 to 1.5 μg / 100 g, more preferably 0.2 to 1.2 μg / 100 g, and even more preferably 0.4 to 0.9 μg / 100 g. Furthermore, the composition of the present invention contains folic acid preferably in an amount of 5 to 80 μg / 100 g, more preferably 10 to 60 μg / 100 g, and even more preferably 20 to 50 μg / 100 g. Furthermore, the composition of the present invention contains pantothenic acid in an amount of preferably 0.4 to 1.7 mg / 100 g, more preferably 0.5 to 1.6 mg / 100 g, and even more preferably 0.6 to 1.3 mg / 100 g. Furthermore, the composition of the present invention contains biotin in an amount of preferably 1.0 to 40 μg / 100 g, more preferably 2.0 to 37 μg / 100 g, and even more preferably 3.0 to 15 μg / 100 g. Furthermore, the composition of the present invention contains vitamin C in an amount of preferably 10 to 100 mg / 100 g, more preferably 20 to 90 mg / 100 g, and even more preferably 25 to 70 mg / 100 g.
[0057] (5-3) High-intensity sweeteners The composition of the present invention may further contain a high-intensity sweetener. The high-intensity sweetener is also called a non-sugar sweetener. Examples of the high-intensity sweetener include sucralose, acesulfame potassium, aspartame, stevia, and licorice. The composition may include any one or a combination of two or more of the high-intensity sweeteners listed above. In one embodiment, the composition comprises sucralose. For example, the composition may comprise a combination of sucralose and acesulfame potassium. The content of the high-intensity sweetener may be appropriately determined by those skilled in the art according to the desired degree of sweetness, and may be, for example, 0.0001% by mass or more, preferably 0.001% by mass or more, more preferably 0.01% by mass or more, based on the mass of the composition of the present invention. By setting the content at or above this lower limit, an appropriate sweetness is expressed. The content of the high-intensity sweetener may be, for example, 1.0% by mass or less, preferably 0.5% by mass or less, 0.3% by mass or less, or 0.2% by mass or less, based on the mass of the composition of the present invention. By keeping the content at or below this upper limit, it is possible to prevent excessive sweetness from being expressed. In some embodiments, the composition may be free of intense sweeteners.
[0058] (5-4)Fragrance The composition according to the present invention may further contain a flavoring agent. The flavoring agent imparts a desired flavor to the composition. The flavoring agent may be, for example, one or a combination of two or more of a fruit flavoring agent, a nut flavoring agent, a beverage flavoring agent, a sweet flavoring agent, a dairy flavoring agent, and a vanilla flavoring agent, but may also be other flavoring agents.
[0059] The content of the fragrance may be, for example, 0.001% by mass or more, preferably 0.01% by mass or more, more preferably 0.02% by mass or more, 0.04% by mass or more, 0.06% by mass or more, or 0.08% by mass or more, and even 0.1% by mass or more, relative to the mass of the composition. The content of the fragrance may be, for example, 2% by mass or less, preferably 1% by mass or less, preferably 0.8% by mass or less, more preferably 0.6% by mass or less, 0.4% by mass or less, or 0.2% by mass or less, relative to the mass of the composition. In some embodiments, the composition may be fragrance-free.
[0060] (5-5) Acidulants The composition according to the present invention may further comprise an acidulant, which imparts a sour taste to the composition or adjusts the pH of the composition. Examples of the acidulant include adipic acid, citric acid, gluconic acid, succinic acid, acetic acid, tartaric acid, lactic acid, fumaric acid, malic acid, and phosphoric acid, and salts thereof. In some embodiments, the composition may be free of an acidulant.
[0061] (5-6) Coloring agent The composition according to the present invention may further comprise a colorant, the type of which may be appropriately selected by a person skilled in the art, for example to adjust the appearance, in particular the color, of the composition. In some embodiments, the composition may be free of colorants.
[0062] (5-7) Thickener The agar and / or carrageenan contained in the composition of the present invention has a thickening effect in addition to a protein gastric emptying regulating effect, and therefore the agar and / or carrageenan may be used as a thickening agent in the composition of the present invention. In addition, the composition of the present invention may contain a thickener other than agar and carrageenan in order to adjust its viscosity. Some dietary fibers also have a thickening effect, so they may be used as thickeners in the composition of the present invention. Examples of such thickeners include pectin, gelatin, xanthan gum, guar gum, tara gum, locust bean gum, gellan gum, and gum arabic. The composition of the present invention may contain one or more selected from these.
[0063] (5-8) Moisture The compositions of the present invention may further comprise water, i.e., may be constituted as aqueous compositions. The water content in the composition may be, for example, 10% by mass or more, 30% by mass or more, 50% by mass or more, 60% by mass or more, 70% by mass or more, or 75% by mass or more, relative to the mass of the composition. The water content in the composition may be, for example, 95% by mass or less, 90% by mass or less, 85% by mass or less, or 80% by mass or less, relative to the mass of the composition. By containing water, the composition of the present invention can be easily constituted as a flowable composition and can be easily administered.
[0064] 6. Physical properties of the composition In one embodiment, the composition of the present invention may preferably have fluidity, i.e., may be configured as a fluid composition. The composition may be, in particular, a fluid liquid, thickened, or gel (jelly) composition. For example, the composition of the present invention may be a liquid food. It is considered that the composition of the present invention in such a form is more likely to exert the effect of adjusting gastric emptying of protein by agar and / or carrageenan.
[0065] Preferably, the composition is a flowable composition having a viscosity that allows spontaneous dripping. The composition of the present invention is configured as such a flowable composition, which makes it easier to administer to a subject who ingests the composition, for example, makes it easier to administer the composition of the present invention enterally. That is, the composition of the present invention may be used to administer the nutritional components contained in the composition enterally, and may be used to administer the nutritional components orally or by tube feeding in particular.
[0066] When the composition of the present invention is a composition having fluidity as described above, various physical properties of the composition may be set, for example, as follows.
[0067] The viscosity of the composition of the present invention at 20° C. may be, for example, 10 mPa·s or more, preferably 50 mPa·s or more, and more preferably 100 mPa·s or more. In some embodiments, the viscosity may be even higher, for example, 300 mPa·s or more, 500 mPa·s or more, or 800 mPa·s or more, or even 1000 mPa·s or more, 1300 mPa·s or more, or 1500 mPa·s or more. The viscosity may be, for example, 20,000 mPa·s or less, or 10,000 mPa·s or less, preferably 8,000 mPa·s or less, more preferably 6,000 mPa·s or less, or even 5,000 mPa·s or less, 4,000 mPa·s or less, or 3,000 mPa·s or less. By virtue of having such a viscosity, the composition of the present invention becomes a flowable composition which is easy to administer. The viscosity is measured at 20° C. using a Brookfield viscometer, and the specific measurement conditions are as follows. Measuring device: TVB-10 (Toki Sangyo Co., Ltd.) Measurement container: Cylindrical container with a diameter of 63 mm and a height of 128 mm Measurement container capacity: 450cc Spindle rotor type: M1, M2, M3 or M4 (selected according to viscosity) Temperature: 20℃ Rotation speed: 6 rpm Measurement time: 120 seconds
[0068] The pH of the composition of the present invention at 20° C. may be, for example, 9.0 or less, particularly 8.5 or less, more particularly 8.0 or less, or even 7.5 or less. The pH may for example be 5.0 or higher, in particular 5.5 or higher, more in particular 6.0 or higher. By having such a pH, denaturation of components (for example, proteins) that may be contained in the composition of the present invention can be prevented.
[0069] The specific gravity of the composition of the present invention at 20° C. may be, for example, from 1.00 to 1.20, and particularly from 1.03 to 1.15.
[0070] In some embodiments, the composition of the present invention may be configured as a composition that does not have fluidity.For example, the composition of the present invention may be a solid, and in particular may be a solid composition configured to exert a protein gastric emptying control effect.The composition may be configured as, for example, various solid foods, or may be configured as a supplement or medicine having a solid dosage form such as powder, granule, or tablet.For example, the composition of the present invention may be in the form of a paste, powder, or solid.
[0071] 7. Manufacturing method The method for producing the composition of the present invention can be selected or designed by those skilled in the art depending on the formulation and / or form of the composition. In particular, the composition may be produced so that the protein gastric emptying regulating effect of agar and / or carrageenan is exerted in a human who ingests the composition.
[0072] A method for producing the composition of the present invention when the composition is a flowable composition will be described below.
[0073] The manufacturing method may include a solution preparation step of dissolving the agar and / or carrageenan in an aqueous medium such as water or an aqueous solution to prepare a solution (hereinafter also referred to as "agar / carrageenan solution"). The aqueous solution may be, for example, water in which a water-soluble component (e.g., protein and / or carbohydrate, etc.) or another water-soluble component (e.g., a pH adjuster such as an acid or alkali, or a salt, etc.) described below is dissolved. For the dissolution, the aqueous medium may be heated to a temperature at which the agar and / or the carrageenan dissolves. The temperature may be appropriately selected depending on the type of the agar and / or the carrageenan, and may be, for example, 50°C or higher, 60°C or higher, 70°C or higher, or 80°C or higher. The temperature may be, for example, 100°C or lower. By heating the aqueous medium to such a temperature, the agar and / or the carrageenan is easily dissolved. After the dissolution, the agar / carrageenan solution may be cooled to a temperature at which the solution is used. In some embodiments, the agar / carrageenan solution may be utilized as a composition of the present invention.
[0074] The agar / carrageenan solution may further be mixed with various components to be included in the composition of the present invention. For example, the agar / carrageenan solution may further be mixed with a protein. For example, the protein may be mixed with the agar / carrageenan solution in a state dissolved in an aqueous medium such as water or an aqueous solution (i.e., as a protein solution), or the protein may be mixed with the soluble agar / carrageenan solution in a state not dissolved in an aqueous medium (e.g., as a solid such as a powder). In this way, a composition containing a protein in addition to the agar and / or the carrageenan may be obtained. The composition may be used as a composition according to the present invention.
[0075] A carbohydrate may be further mixed with the agar / carrageenan solution. For example, the carbohydrate may be mixed with the agar / carrageenan solution in a state dissolved in an aqueous medium, such as water or an aqueous solution (i.e. as a carbohydrate solution), or the carbohydrate may be mixed with the agar / carrageenan solution in a state not dissolved in an aqueous medium (e.g. as a solid, such as a powder). In this way, a composition may be obtained which further comprises a carbohydrate in addition to the agar and / or the carrageenan (and optionally the protein). The composition may be used as a composition according to the present invention.
[0076] The agar / carrageenan solution may further comprise a lipid, for example, the lipid may be mixed with the agar / carrageenan solution in liquid form or may be mixed with the agar / carrageenan solution in solid form. In order to mix the lipid well with the agar / carrageenan solution or to stably emulsify the lipid, a homogenization step or a dispersion step may be performed, for example. In order to mix the lipid well with the agar / carrageenan solution (particularly a dispersion step) or to stably emulsify the lipid (particularly a homogenization step), for example, a homogenizer known in the art and / or an emulsifier known in the art may be used. The homogenization step may be performed in a state in which each component to be included in the composition of the present invention is mixed, or may be performed on only a part of the composition of the present invention, for example, by performing a homogenization step only on the part other than the agar / carrageenan and then mixing the agar / carrageenan. The composition of the present invention thus obtained may be an emulsion, and in particular may be an oil-in-water emulsion. In this way, a composition may be obtained which further comprises lipids in addition to the agar and / or the carrageenan (and optionally the protein and / or carbohydrate), which may be used as a composition according to the invention.
[0077] The agar / carrageenan solution may further contain other components as described in (5) above. Which of these other components is used may be appropriately designed by those skilled in the art depending on the composition of the composition to be produced. The timing of adding and mixing these other components may also be appropriately selected by those skilled in the art.
[0078] In preparing the agar / carrageenan solution, a solution having a higher content ratio of each component than the content ratio of each component in the composition to be produced may be prepared. In this case, after the preparation of the solution, water may be added to the solution and mixed to adjust the content ratio of each component to the value in the composition. In the present invention, the content ratio of each component in the composition may be adjusted by such a filling up.
[0079] The production method may include a sterilization step of sterilizing the agar / carrageenan solution. The sterilization step may be performed by any method known in the art, such as retort sterilization, indirect heat sterilization (plate type, tubular type, or scraping type), direct heat sterilization (steam injection type or steam infusion type), etc. The temperature and treatment time employed in the sterilization step may be appropriately selected by a person skilled in the art depending on the sterilization method.
[0080] The method may or may not further include a homogenization step of homogenizing the agar / carrageenan solution. The homogenization step may be carried out using a homogenizer. The homogenizer may be any device known in the art. The pressure for the homogenization process may be appropriately selected by those skilled in the art depending on the formulation of the composition. The sterilization step may be performed after the homogenization step, or the homogenization step may be performed after the sterilization step.
[0081] The manufacturing method may further include a cooling step of cooling the agar / carrageenan solution after the sterilization step (or after a homogenization step, if both steps are performed in addition to the sterilization step). The cooling is performed so as to maintain the sterilized state of the agar / carrageenan solution. The cooling step may be performed by any method known in the art, and may utilize any known cooling device.
[0082] The manufacturing method may further include a filling step of filling the agar / carrageenan solution into a container after the cooling step. The filling step may be performed after the sterilization step, or may be performed before the sterilization step. When the filling step is performed after the sterilization step, the filling step may be performed aseptically. The container may be, for example, a plastic bag, but the type of the container is not limited thereto, and may be a plastic bottle, a plastic cup, an aluminum pouch, a paper pack, a metal can, or a glass container. Preferably, the container is a plastic bag, which allows for easy tube feeding of the composition of the invention to a user. The agar / carrageenan solution filled in a container by the filling step may be provided to a user as the composition of the present invention. That is, the composition of the present invention may be sold in a state filled in a container.
[0083] In the filling step, for example, 10 ml to 2000 ml, particularly 50 ml to 1500 ml, more particularly 100 ml to 1000 ml, and even more particularly 200 ml to 600 ml of the composition of the present invention may be filled per container.
[0084] As described above, the present invention also provides a method for producing the composition according to the present invention. The method may include the above-mentioned solution preparation step. The method may include carrying out one or more of the above-mentioned pasteurization step, homogenization step, and filling step after the solution preparation step.
[0085] Even if the composition of the present invention does not have fluidity, a person skilled in the art can appropriately prepare the composition depending on the composition configuration. In particular, the composition is prepared so that the gastric emptying of protein is regulated by agar and / or carrageenan in the final product. For example, when the composition of the present invention is constituted as a solid food, agar and / or carrageenan may be added to the food at any stage in the process of producing the solid food. In addition, when the composition of the present invention is configured as a supplement or drug having a solid dosage form such as powder, granules, or tablets, agar and / or carrageenan may be added at any stage in the process of producing the supplement or drug, such as during the granulation process.
[0086] 8.How to use The composition of the present invention may be ingested in various situations, for example, where the regulation of gastric emptying of protein is required. The subject to which the composition is ingested is particularly a human. That is, the composition may be administered to a human who is required to regulate the gastric emptying of protein.
[0087] The compositions of the present invention may be used, for example, in providing protein supplementation to humans. For example, the protein-containing composition may be administered orally or by tube feeding to provide protein. Tube feeding may be nasal, gastrostomy, or enterostomy. For example, the subject may be provided with a nasogastric feeding tube. The protein-containing composition may be constituted as a composition according to the invention, ie it may contain agar and / or carrageenan. Alternatively, an agar- and / or carrageenan-containing composition according to the invention may be administered together with the protein-containing composition, i.e., an agar- and / or carrageenan-containing composition according to the invention may be administered to a human to regulate the gastric emptying of the protein provided by a protein-containing composition provided separately from the composition according to the invention. In this way, the composition of the present invention is used to create a state in the stomach where agar and / or carrageenan are present simultaneously with proteins, thereby regulating the gastric emptying of the proteins.
[0088] The composition of the present invention may be, for example, configured as a flowable composition (e.g., enteral nutritional agent, etc.) and may be used to provide nutritional supplementation to humans. The composition of the present invention, when supplied to the stomach, regulates (particularly promotes or inhibits) the excretion of proteins present in the stomach out of the stomach (particularly excretion via the pylorus). The composition of the present invention may be used for nutritional supplementation, for example, by tube feeding. That is, the enteral nutritional agent for tube feeding may be the composition according to the present invention. As described above, the composition of the present invention can be given fluidity suitable for tube feeding by agar and / or carrageenan. That is, the present invention can impart fluidity suitable for tube feeding to the composition and adjust gastric emptying of protein. Thus, the composition of the present invention may be used for nutritional supplementation. That is, the present invention also provides a nutritional composition comprising agar and / or carrageenan. The nutritional composition may be used to regulate gastric emptying of protein, for example, to regulate gastric emptying of protein contained in the nutritional composition.
[0089] Furthermore, as described above, the composition of the present invention is useful for regulating gastric emptying of protein, and may also be used in applications based on other actions that occur in association with this action.
[0090] For example, muscle synthesis can be promoted by the action of promoting protein gastric emptying. Therefore, the composition of the present invention (particularly the composition for promoting protein gastric emptying) may be used as a composition for promoting muscle synthesis. That is, the present invention also provides a composition for promoting muscle synthesis containing agar. The composition for promoting muscle synthesis may be a composition used to promote muscle synthesis by the action of promoting protein gastric emptying.
[0091] Subjects who need to have muscle synthesis promoted are not particularly limited as long as they desire the effect of promoting muscle synthesis, but examples include subjects aged 65 or older, subjects diagnosed with sarcopenia, and athletes.
[0092] The muscle synthesis promoting effect of the present invention can be confirmed, for example, by an increase in lean body mass measured by bioelectrical impedance analysis when the composition of the present invention is ingested, compared to when a composition containing the same amount of protein as the composition of the present invention is ingested, but the method of confirmation is not limited to this.
[0093] Incretin secretion can be promoted by the action of promoting protein gastric emptying. Therefore, the composition of the present invention may be used as a composition for promoting incretin secretion. That is, the present invention also provides a composition for promoting incretin secretion comprising agar. The composition for promoting incretin secretion may be a composition used to promote incretin secretion by the action of promoting protein gastric emptying. Incretin secretion is also useful for suppressing an increase in blood glucose level, and therefore the composition of the present invention may be a composition for suppressing an increase in blood glucose level.
[0094] There are no particular limitations on the subjects who require promotion of incretin secretion, so long as they desire the incretin secretion promoting effect, but examples of such subjects include subjects diagnosed with diabetes and subjects with high blood sugar levels.
[0095] The incretin secretion promoting effect of the present invention can be confirmed, for example, by the maximum blood GLP-1 concentration being higher when the composition of the present invention is ingested compared to when a composition containing the same amount of protein as the composition of the present invention is ingested, but the method of confirmation is not limited to this.
[0096] Furthermore, the suppressive effect of gastric emptying of protein can reduce the burden on the kidneys. Therefore, the composition of the present invention (particularly, the composition for suppressing gastric emptying of protein) may be used as a composition for reducing the burden on the kidneys. That is, the present invention also provides a composition for reducing the burden on the kidneys, which contains carrageenan. The composition for reducing the burden on the kidneys may be a composition used to reduce the burden on the kidneys by the suppressive effect of gastric emptying of protein.
[0097] Subjects who need to reduce the burden on the kidneys are not particularly limited as long as they desire the effect of reducing the burden on the kidneys, but examples include subjects diagnosed with kidney disease, subjects aged 65 or older, subjects diagnosed with metabolic syndrome, and athletes.
[0098] The effect of the present invention in reducing kidney burden can be confirmed, for example, by a decrease in the maximum glomerular filtration rate within 3 hours after ingestion of the composition of the present invention, compared to ingestion of a composition containing approximately the same amount of protein as the composition of the present invention, but the method of confirmation is not limited to this.
[0099] The stomach emptying inhibitory effect of protein can sustain a feeling of fullness. Therefore, the composition of the present invention (particularly, the composition for suppressing stomach emptying of protein) may be used as a composition for sustaining a feeling of fullness. That is, the present invention also provides a composition for sustaining a feeling of fullness containing carrageenan. The composition for sustaining a feeling of fullness may be a composition used for sustaining a feeling of fullness by the stomach emptying inhibitory effect of protein.
[0100] Subjects who require a sustained feeling of fullness are not particularly limited as long as they desire the effect of sustaining a feeling of fullness, and examples thereof include subjects diagnosed as needing dietary restrictions, subjects diagnosed with metabolic syndrome, and athletes.
[0101] The effect of the present invention on sustaining a feeling of fullness can be confirmed, for example, by the prolonged feeling of fullness measured using a visual analogue scale when the composition of the present invention is ingested, compared to when a composition containing the same amount of calories as the composition of the present invention is ingested; however, the method of confirmation is not limited to this.
[0102] 9. Food and drink composition The composition of the present invention may be used as a food and drink composition. The food and drink composition of the present invention may be configured as a composition having fluidity as described above, and may have, for example, a liquid or gel form. Alternatively, the food and drink composition of the present invention may be configured as a composition having no fluidity.
[0103] The food and drink composition of the present invention can be provided or sold as a food and drink labeled for its use in regulating gastric emptying of protein. When the food and drink composition of the present invention contains agar (particularly when it is a composition for promoting gastric emptying of protein), it can be provided and / or sold with a label indicating that it is intended for consumption by people who wish to promote muscle synthesis, people who wish to promote muscle growth, people who are useful for maintaining muscle mass and muscle strength, people who support the ability to build muscle, people who are useful for improving walking ability, people who are useful for maintaining and preventing muscle strength loss, people who wish to promote incretin secretion, people who wish to suppress an increase in blood glucose level, people who wish to moderate an increase in postprandial blood glucose level, or people who wish to promote gastric emptying of protein. It can also be provided and / or sold with a label indicating that it is intended for people with diabetes. Furthermore, when the food and drink composition of the present invention contains carrageenan (particularly when it is a composition for inhibiting gastric emptying of protein), it can be provided and / or sold with a label indicating that it is for "those concerned about kidney burden," "those who wish to maintain a feeling of fullness," or "those who wish to inhibit gastric emptying of protein," etc. Furthermore, it can be provided and / or sold with a label indicating that it is for patients with kidney disease. The act of "displaying" includes all acts for informing consumers of the uses of the composition of the present invention, and any expression that can recall and / or infer said uses falls under the act of "displaying" in the present invention, regardless of the purpose of the display, the content of the display, the object and / or medium on which it is displayed.
[0104] Furthermore, it is preferable that the "labeling" be done in an expression that allows consumers to directly recognize the above-mentioned uses.Specific examples include the act of transferring, delivering, displaying for the purpose of transferring or delivering, or importing food and beverage products or product packaging on which the above-mentioned uses are written, displaying or distributing advertisements, price lists, or transaction documents related to the products and writing the above-mentioned uses in information containing the above-mentioned uses and providing them by electromagnetic means (such as the Internet), etc.
[0105] On the other hand, the content of the labeling is preferably a labeling approved by the government etc. (for example, a labeling approved based on various systems established by the government and made in a manner based on such approval, etc.) In addition, it is preferable that such a labeling content is affixed to the packaging, containers, catalogs, pamphlets, POP and other sales site promotional materials, other documents, etc.
[0106] Other examples of "labeling" include labeling as health foods, functional foods, enteral nutritional foods, special purpose foods, health functional foods, foods for specified health uses, foods for the sick, foods for people with dysphagia, foods for thickening, nutritional functional foods, foods with functional claims, quasi-drugs, etc.
[0107] 10. Pharmaceutical Compositions The composition of the present invention may be used as a pharmaceutical composition. The pharmaceutical composition of the present invention may be configured as a composition having flowability as described above, and may have, for example, a liquid or gel form. Alternatively, the pharmaceutical composition of the present invention may be configured as a composition having no flowability.
[0108] When the composition of the present invention is used as a pharmaceutical composition, the pharmaceutical composition may be administered orally or parenterally, and may be formulated into a desired dosage form depending on the administration method.For example, when administered orally, the composition may be formulated into a desired dosage form (liquid, jelly, or paste).In addition, when administered parenterally, the composition of the present invention may be administered, for example, via a gastrostomy, and may be administered enterally.
[0109] In addition, when formulated, the pharmaceutical composition of the present invention may contain additives that are usually used in formulations (e.g., pH adjusters, colorants, flavoring agents, etc.) In addition, the pharmaceutical composition of the present invention may contain other active ingredients (particularly medicinal ingredients) that are known or will be discovered in the future, so long as they do not impair the effects of the present invention. In addition, formulation can be carried out by a known method as appropriate depending on the dosage form. When preparing the formulation, a pharmaceutical carrier may be appropriately added to the formulation.
[0110] 11. Example of nutritional composition For efficient nutritional supplementation, the composition of the present invention may have, for example, the following nutritional composition: The calorific value per 100 g of the composition may be, for example, 50 kcal or more, preferably 55 kcal or more, more preferably 60 kcal or more or less. The calorific value per 100 g of the composition may be, for example, 150 kcal or less, particularly 140 kcal or less, more particularly 130 kcal or less. The composition of the present invention may be configured as a composition having a relatively high calorific value in this way, but the calorific value of the composition of the present invention is not limited thereto, and may be configured as a composition having a lower calorific value, for example. For example, the calorific value per 100 g of the composition may be, for example, 50 kcal or less, 40 kcal or less, or 30 kcal or less.
[0111] The protein content per 100 g of the composition may be, for example, 2 g or more, preferably 3 g or more.The protein content per 100 g of the composition may be, for example, 10 g or less, in particular 9 g or less, more in particular 8 g or less. The lipid content per 100 g of the composition may be, for example, 0.1 g or more, preferably 0.5 g or more, more particularly 1.0 g or more. The lipid content per 100 g of the composition may be, for example, 5 g or less, particularly 4 g or less, more particularly 3 g or less. The carbohydrate content per 100 g of the composition may be, for example, 8.0 g or more, preferably 10.0 g or more.The carbohydrate content per 100 g of the composition may be, for example, 25 g or less, preferably 20 g or less, more preferably 18 g or less. The ash content per 100 g of the composition may be, for example, 0.3 g or more, preferably 0.4 g or more, more preferably 0.5 g or more.The ash content per 100 g of the composition may be, for example, 1.5 g or less, preferably 1.2 g or less, more preferably 1.0 g or less.
[0112] Preferable compositions of the composition of the present invention include, for example, the following embodiments (i) and (ii). Mode (i): Protein content is 2.5 to 4.5% by mass, lipid content is 1.8 to 3% by mass, carbohydrate content is 10 to 15% by mass, moisture content is 75 to 85% by mass, and agar content is 0.05 to 0.2% by mass; per 100 g of the composition, the content is 120 to 200 mg of sodium, 45 to 90 mg of calcium, 100 to 170 mg of potassium, 60 to 120 μg RAE of vitamin A, 0.5 to 0.8 μg of vitamin D, 0.9 to 1.6 mg of vitamin E, 6 to 10 μg of vitamin K, 0.2 to 0.4 mg of vitamin B1, 0.2 to 0.4 mg of vitamin B2, 2 to 4 mg of niacin, 0.2 to 0.4 mg of vitamin B6, 25 to 50 μg of folic acid, 0.5 to 0.8 μg of vitamin B12, 4 to 7 μg of biotin, 0.7 to 1.2 mg of pantothenic acid, and 30 to 60 mg of vitamin C; and the viscosity at 20°C is 800 to 2800 mPa·s. Mode (ii): Protein content is 2.5 to 4.5% by mass, lipid content is 1.8 to 3% by mass, carbohydrate content is 10 to 15% by mass, moisture content is 75 to 85% by mass, and carrageenan content is 0.02 to 0.2% by mass; per 100 g of the composition, the content is 120 to 200 mg of sodium, 45 to 90 mg of calcium, 100 to 170 mg of potassium, 60 to 120 μg RAE of vitamin A, 0.5 to 0.8 μg of vitamin D, 0.9 to 1.6 mg of vitamin E, 6 to 10 μg of vitamin K, 0.2 to 0.4 mg of vitamin B1, 0.2 to 0.4 mg of vitamin B2, 2 to 4 mg of niacin, 0.2 to 0.4 mg of vitamin B6, 25 to 50 μg of folic acid, 0.5 to 0.8 μg of vitamin B12, 4 to 7 μg of biotin, 0.7 to 1.2 mg of pantothenic acid, and 30 to 60 mg of vitamin C; and the viscosity at 20°C is 800 to 2800 mPa·s.
[0113] The composition of the present invention described in the above aspect (i) has an effect of promoting gastric emptying of protein. In addition, since it contains various nutrients in a well-balanced manner and is a fluid composition having a viscosity that allows spontaneous dripping, it can be administered, for example, by tube feeding. The composition of the present invention described in the above embodiment (ii) has an effect of suppressing gastric emptying of protein. In addition, since it contains various nutrients in a well-balanced manner and is a fluid composition having a viscosity that allows spontaneous dripping, it can be administered, for example, by tube feeding.
[0114] 12. Other embodiments of the present invention The present invention also provides the following methods and products. The present invention may be configured as described below. These methods and products are based on the contents described in this specification, and the contents of the description also apply to these methods and products. [1] [1-1] Use of agar, carrageenan, or both for regulating gastric emptying of protein. [1-2] Use of agar to promote gastric emptying of protein. [1-3] Use of agar for promoting muscle synthesis, in particular for promoting muscle synthesis by promoting gastric emptying of protein. [1-4] Use of agar for promoting incretin secretion, in particular for promoting incretin secretion by promoting gastric emptying of protein. "1-5" A method for promoting gastric emptying of protein, comprising administering agar to a subject. [1-6] Use of carrageenan for inhibiting gastric emptying of protein. [1-7] Use of carrageenan to reduce kidney load, in particular by inhibiting gastric emptying of protein. [1-8] Use of carrageenan to maintain satiety, particularly by inhibiting gastric emptying of protein. [1-9] A method for inhibiting gastric emptying of protein, comprising administering carrageenan to a subject. [2] [2-1] Agar, carrageenan, or a combination of agar and carrageenan used to regulate gastric emptying of protein. [2-2] Agar used to promote gastric emptying of protein. [2-3] Agar used to promote muscle synthesis, especially agar used to promote muscle synthesis by promoting gastric emptying of protein. [2-4] Agar used to promote incretin secretion, especially muscle synthesis by promoting gastric emptying of protein. [2-5] Carrageenan used to inhibit gastric emptying of proteins. [2-6] Carrageenan is used to reduce the burden on the kidneys, in particular by inhibiting gastric emptying of protein. [2-7] Carrageenan used to maintain satiety, especially by inhibiting gastric emptying of protein. [3] [3-1] Use (or application) of agar, carrageenan, or both in the manufacture of a protein gastric emptying regulating composition. [3-2] Use (or application) of agar in the manufacture of a composition for promoting gastric emptying of protein. [3-3] Use (or application) of agar in the production of a composition for promoting muscle synthesis, particularly in the production of a composition for promoting muscle synthesis by promoting gastric emptying of protein. [3-4] Use (or application) of agar in the production of a composition for promoting incretin secretion, particularly in the production of a composition for promoting incretin secretion by promoting gastric emptying of protein. [3-5] Use (or application) of carrageenan in the manufacture of a composition for inhibiting gastric emptying of protein. [3-6] Use (or application) of carrageenan in the production of a composition for reducing burden on the kidneys, particularly in the production of a composition for reducing burden on the kidneys by inhibiting gastric emptying of protein. [3-7] Use (or application) of carrageenan in the production of a composition for sustaining satiety, particularly in the production of a composition for sustaining satiety by inhibiting gastric emptying of protein.
[0115] 13. Working Example
[0116] 13.1 Methods for Measuring Gastric Emptying The gastric emptying measurement used in the following examples was carried out according to the method described in Food Function (2020) Vol. 11, 1702-1720. Specifically, the measurement was carried out as follows.
[0117] <Preparation of reagents and samples> (1-1) Preparation of 1.25× simulated gastric juice electrolyte solution (also called “1.25× eSGF”) 17.25 mL of 0.5 M KCl, 2.25 mL of 0.5 M KH2PO4, 31.25 mL of 1 M NaHCO3, 29.5 mL of 2 M NaCl, 1 mL of 0.15 M MgCl2, and 1.25 mL of 0.5 M (NH4)2CO3 were mixed, then ultrapure water was added to make up to 1000 mL, and the pH was adjusted to 7 with 6 M HCl to obtain 1.25 × eSGF.
[0118] (1-2) Preparation of gastric digestive enzyme solution Pepsin solution was obtained by dissolving porcine gastric mucosa-derived pepsin (Sigma-Aldrich; Cat. P7012) in 1.25x eSGF at 80,000 U / mL. Lipase solution was obtained by dissolving Rhizopus oryzae-derived lipase (Sigma-Aldrich; Cat. 80612) in 1.25x eSGF at 2,400 U / mL. These two solutions were mixed in amounts of 1.5 mL each to obtain a gastric digestive enzyme solution.
[0119] (1-3) Measurement of HCl content in enzyme-free simulated gastric juice The amount of HCl in the enzyme-free simulated gastric juice used for each composition sample in (2-1) below was measured in advance by the following procedure. 0.02 mL of 0.3 M CaCl2 was added to 32 mL of 1.25 × eSGF, and the mixture was diluted to 40 mL with ultrapure water to obtain a CaCl2 solution. 30 mL of the composition sample to be evaluated was added to 30 mL of the CaCl2 solution, and titrated with 1.5 M HCl while stirring with a stirrer, and the amount (volume) of 1.5 M HCl required to reach pH 2 was measured.
[0120] (1-4) Preparation of fasting simulated gastric juice 2.1 mL of 1.25×eSGF, 1.5 M HCl in an amount that was 10% of the amount of 1.5 M HCl in the enzyme-free simulated gastric fluid measured in (1-3), 1.5 μL of 0.3 M CaCl2, and 0.3 mL of the gastric digestive enzyme solution prepared in (1-2) were mixed, and then the mixture was diluted with ultrapure water to a total volume of 3 mL to obtain a fasting simulated gastric fluid.
[0121] (1-5) Preparation of enzyme-free simulated gastric juice 18.9 mL of 1.25×eSGF, 90% of the amount of 1.5 M HCl in the enzyme-free simulated gastric fluid measured in (1-3), and 13.5 μL of 0.3 M CaCl2 were mixed, and then the mixture was diluted with ultrapure water to a total volume of 24.3 mL to obtain enzyme-free simulated gastric fluid.
[0122] <Evaluation of composition samples> (2-1) Digestion of composition sample in simulated gastric fluid Digestion of a composition sample in simulated gastric fluid will be described with reference to Figure 1A, which is a schematic diagram for explaining the digestive process. 3 mL of the fasting simulated gastric juice prepared in (1-4) was placed in a 70 mL V-shaped insulated beaker (Metrohm; Cat. 6.1418.150) and kept at 37°C, and 30 mL of the composition sample was added thereto. 24.3 mL of enzyme-free simulated gastric juice was added to the V-shaped insulated beaker at a flow rate of 0.090 mL / min for Examples 1 to 3 and 0.1215 mL / min for Example 4, and 2.7 mL of gastric digestive enzyme solution was added to the V-shaped insulated beaker at a flow rate of 0.01 mL / min for Examples 1 to 3 and 0.0135 mL / min for Example 4. The gastric digestion reaction was carried out with stirring using a 3D shaker (product number 1-4103-01, company name AS ONE, shaking speed 35 rpm). For Examples 1 to 3, 12 mL of digested product samples were collected at 54 minutes, 108 minutes, 162 minutes, 216 minutes, and 270 minutes, and for Example 4, 12 mL of digested product samples were collected at 40 minutes, 80 minutes, 120 minutes, 160 minutes, and 200 minutes, using an electric pipette with a tip inner diameter of 2 mm, which is assumed to be gastric discharge from the pylorus. The obtained digested product samples were adjusted to pH 7 to 11 with 2M NaOH, and the reaction was terminated by boiling for 5 minutes. The samples were then freeze-dried. In this manner, freeze-dried samples were collected at each time point. 1B shows a photograph of the composition sample contained in the V-shaped insulated beaker. As shown in the photograph, a sample was taken from the composition sample in which digestion had progressed using an electronic pipette.
[0123] (2-2) Analysis of nutritional components in collected stomach digestion samples The protein concentration of each freeze-dried sample was measured by the modified Dumas method, and the carbohydrate concentration was measured by the phenol-sulfuric acid method. These concentrations were used to calculate the protein and carbohydrate concentrations of the samples taken with the electronic pipette.
[0124] 13.2 Example 1
[0125] Composition samples (Compositions 1-1 to 1-6) having the compositions and properties shown in Tables 1A to 1C below were prepared. All six of these compositions have the same nutritional composition, as shown in Table 1A. In addition, these six compositions differ in the type and / or amount of thickener, as shown in the recipe in Table 1B. As shown in the table, composition 1-1 does not contain a thickener, while compositions 1-2 to 1-6 contain a thickener. When a thickener is contained, the amount of resistant dextrin is reduced by an amount equivalent to the amount of the thickener in order to keep the nutritional composition the same. The properties of these six compositions are also shown in Table 1C.
[0126] [Table 1]
[0127] The composition samples were prepared as follows. Milk caseinate sodium powder (Tatsua), mineral mixture (Tomita Pharmaceutical), and vitamin raw material (DSM) were dissolved and mixed in warm water, and then adjusted fat (Taiyo Yushi) was added and homogenized. Liquid sugar (Matsutani Chemical Industry) was then added, and some samples were mixed with each thickener raw material dissolved in hot water, agar A [jelly strength: 300g / cm 2 ] or Agar B [Jelly strength: 680g / cm 2 ] (both manufactured by Ina Food Industry Co., Ltd.), gellan gum (manufactured by San-Ei Gen F.F.I.), or guar gum (manufactured by San-Ei Gen F.F.I.) were added and mixed. The raw material composition thus obtained was filled into a container and retort sterilized at 120°C for 4 minutes or more to prepare a liquid composition having the nutritional composition shown in Table 1A. As shown in Tables 1B and 1C, the amount of thickener added was adjusted so that the viscosity of compositions 1-2 and 1-4 was almost the same (particularly 1,800±1,000 mPa·s). Composition 1-1 does not contain a thickener, so its viscosity is low. Composition 1-3 contains the same amount of thickener as composition 1-4, but the type of thickener is guar gum, so its viscosity is lower than that of composition 1-4. Composition 1-5 contains the same thickener as composition 1-4, but the viscosity is higher than that of composition 1-4 due to the increased amount of thickener. Composition 1-6 uses a different type of agar (agar with a different jelly strength) from composition 1-4, so its viscosity is slightly higher than that of composition 1-4.
[0128] The protein concentration and carbohydrate concentration of the prepared composition samples were measured as described in 9.1 above. Furthermore, the ratio of carbohydrate concentration / protein concentration was calculated. The pH of the samples was also measured at each time point. These results are shown in Figures 2A to 2D. Figure 2A is a graph showing the protein concentration in the digested sample at each time point. Figure 2B is a graph showing the carbohydrate concentration in the digested sample at each time point. Figure 2C is the ratio of these concentrations. In addition to the vertical bars showing the calculated concentration ratios, the figure also shows a line showing the theoretical ratio of carbohydrate concentration / protein concentration. The theoretical ratio shows the theoretical ratio when the carbohydrate and protein contained in the composition sample are present in the digested sample at the same ratio as in the composition. The value of the theoretical ratio decreases over time because the protein derived from the digestive enzyme added in the digestion process is taken into account. In other words, this is the ratio of carbohydrate concentration / protein concentration in the gastric emptying sample obtained at each time point when the simulated gastric fluid is continuously added to the composition sample in this test, assuming that the sample does not separate and remains in a homogeneous solution state. Generally, the carbohydrate ratio is high in the gastric emptying sample at the early stage of the reaction, because proteins aggregate in the reaction with the simulated gastric fluid and are difficult to excrete. Figure 2D shows the pH measurement results of samples taken at each time point simulating gastric emptying.
[0129] As shown in these results, when the measurement results for Compositions 1-4 and 1-5 are compared with the measurement results for Compositions 1-1 to 1-3, the gastric protein emptying rate of the former is significantly higher than that of the latter at 54 minutes and 108 minutes. In addition, when the measurement results for Composition 1-6 are compared with the measurement results for Compositions 1-1 to 1-3, the stomach emptying of protein for the former is higher than that for the latter at 108 minutes and 162 minutes. These results indicate that agar has the effect of promoting gastric emptying of protein. In addition, when comparing the measurement results for compositions 1-4 and 1-5, which have different agar content ratios, composition 1-5, which has a higher agar content ratio, has a higher protein gastric emptying rate than composition 1-4. Therefore, it can be seen that the degree of the protein gastric emptying promoting effect can be adjusted by the agar content ratio. It can also be seen that composition 1-5 exerts the protein gastric emptying promoting effect for a longer period of time than composition 1-4.
[0130] In addition, in consideration of the time when the gastric emptying promoting effect of protein was confirmed, it is considered that the gastric emptying promoting effect of protein by agar is effectively exerted, for example, within 180 minutes, particularly within 150 minutes, more particularly within 130 minutes, more particularly within 120 minutes, and even more particularly within 110 minutes from the time when the composition reaches the stomach. That is, the composition of the present invention may be used to promote gastric emptying, for example, within 180 minutes, particularly within 150 minutes, more particularly within 130 minutes, more particularly within 120 minutes, and even more particularly within 110 minutes from the time when the target protein reaches the stomach.
[0131] In addition, when the measurement results for composition 1-2 (a composition containing gellan gum) were compared with the measurement results for composition 1-1 (a composition not containing a thickener), the gastric emptying of protein was roughly the same. Therefore, gellan gum is not considered to have the same effect of promoting gastric emptying of protein as agar.
[0132] In addition, as shown in the measurement results for compositions 1-1 to 1-6, the gastric emptying rate of carbohydrates was comparable among these compositions. Therefore, the gastric emptying promotion effect of protein by agar does not affect gastric emptying of carbohydrates, and is considered to be an effect specific to protein. In addition, Composition 1-2 (gellan gum) and Composition 1-4 (agar) have similar viscosities, but as mentioned above, the former did not exhibit any effect of promoting stomach emptying of protein, while the latter did. Therefore, it is considered that the effect of agar in promoting stomach emptying of protein is not brought about by the thickening effect.
[0133] When proteins enter the stomach, they are aggregated by gastric acid. This aggregation inhibits the breakdown of the proteins, and it is believed that this inhibition causes a certain amount of time to be required for the proteins to be emptied from the stomach. It is believed that the agar can be supplied to the stomach by the composition of the present invention, thereby suppressing the aggregation, and it is believed that the suppression of the aggregation promotes the decomposition of proteins and further promotes the gastric emptying of proteins.
[0134] 13.3 Example 2
[0135] Composition samples (Compositions 2-1 to 2-5) having the compositions and properties shown in Tables 2A to 2C below were prepared.
[0136] [Table 2]
[0137] These composition samples were prepared in the same manner as in Example 1, except that the thickening agent shown in Table 2B (gellan gum, guar gum, or carrageenan A) was used. Carrageenan A is iota carrageenan, and its jelly strength is 0.1 to 0.25 N / cm 2 The mass ratio of sulfate groups in carrageenan A is 26% to 27%. The amount of thickener added was adjusted so that the viscosity was roughly the same between Composition 2-2 and Composition 2-4 (specifically, 1,800±1,000 mPa·s). Composition 2-1 did not contain a thickener, so its viscosity was low. Composition 2-3 showed a low degree of viscosity increase due to the use of guar gum as the thickener. Composition 2-5 contained the same thickener as Composition 2-4, but had a higher viscosity due to the increased amount of thickener.
[0138] The protein and carbohydrate concentrations of the prepared composition samples were measured as described in 9.1 above. Furthermore, the carbohydrate / protein ratio was calculated. The pH of the samples was also measured at each time point. The results are shown in Figures 3A-3D. Figure 3A is a graph showing the protein concentration at each time point. Figure 3B is a graph showing the carbohydrate concentration at each time point. Figure 3C is the ratio of these concentrations. Figure 3D is the pH of the samples taken at each time point as gastric emptying.
[0139] As shown in these results, when the measurement results for the compositions containing carrageenan (compositions 2-4 and 2-5) are compared with the measurement results for the composition containing gellan gum (composition 2-2), the composition containing guar gum (composition 2-3), and the composition containing neither carrageenan, gellan gum, nor guar gum (composition 2-1), the stomach protein emptying rate of the former is significantly lower than that of the latter at 54 minutes to 216 minutes. Therefore, it is found that carrageenan has a stomach protein emptying inhibitory effect.
[0140] In addition, when comparing the measurement results of compositions 2-4 and 2-5, which have different carrageenan content ratios, composition 2-5, which has a higher carrageenan content ratio, has a lower stomach protein emptying rate than composition 2-4. Therefore, it can be seen that the degree of stomach protein emptying inhibitory effect can be adjusted by the carrageenan content ratio. It can also be seen that composition 2-5 exerts the stomach protein emptying inhibitory effect for a longer period of time than composition 2-4.
[0141] In addition, considering the time when the inhibitory effect of gastric emptying of protein was confirmed, it is considered that the inhibitory effect of carrageenan on gastric emptying of protein is effectively exerted, for example, within 250 minutes, particularly within 200 minutes, more particularly within 180 minutes, and even more particularly within 150 minutes from the time when the composition reaches the stomach. That is, the composition of the present invention may be used to inhibit gastric emptying, for example, within 250 minutes, particularly within 200 minutes, more particularly within 180 minutes, and even more particularly within 150 minutes from the time when the target protein reaches the stomach.
[0142] In addition, when the measurement results for the composition containing gellan gum (composition 2-2) were compared with the measurement results for the composition containing neither carrageenan nor gellan gum (composition 2-1), the stomach emptying of protein was comparable over the entire measurement period. Therefore, gellan gum is considered not to have the stomach emptying inhibitory effect of protein shown for carrageenan. On the other hand, the composition containing guar gum (composition 2-3) was found to have a slight stomach emptying inhibitory effect. In addition, the composition containing gellan gum (composition 2-2) and the composition containing carrageenan (composition 2-4) were adjusted to have roughly the same viscosity, but as described above, the former did not exhibit any inhibitory effect on stomach emptying of protein, while the latter did. Therefore, it is considered that the inhibitory effect of carrageenan on stomach emptying of protein is not brought about by a thickening effect.
[0143] In addition, the results of the measurements of Compositions 2-1 to 2-5 showed that the gastric emptying of carbohydrates was roughly the same. Therefore, the inhibitory effect of carrageenan on the gastric emptying of protein does not affect the gastric emptying of carbohydrates, and is considered to be a specific effect on protein.
[0144] When proteins enter the stomach, they are aggregated by gastric acid. This aggregation inhibits the degradation of the proteins, and it is believed that this inhibition causes a certain amount of time to be required for the proteins to be discharged from the stomach. It is believed that the composition of the present invention provides carrageenan to the stomach, thereby promoting the aggregation, which in turn inhibits protein degradation and, further, inhibits gastric emptying of proteins.
[0145] 13.4 Example 3
[0146] Composition samples (Composition 3-1 and Composition 3-2) having the compositions shown in Tables 3A to 3C below were prepared.
[0147] [Table 3]
[0148] These composition samples were prepared in the same manner as in Example 1, except that micellar casein (Mirai Co., Ltd.), casein hydrolysate (Morinaga Milk Industry Co., Ltd.), and soy protein (Fuji Oil Co., Ltd.) were used as proteins, and the thickeners shown in Table 3B were used as thickeners. Agar A is as described above in Example 1. Carrageenan B is a combination of kappa and lambda carrageenan.
[0149] The protein and carbohydrate concentrations of the prepared composition samples were measured as described in 9.1 above. Furthermore, the carbohydrate / protein ratio was calculated. The pH of the samples was also measured at each time point. The results are shown in Figures 4A-4D. Figure 4A is a graph showing the protein concentration at each time point. Figure 4B is a graph showing the carbohydrate concentration at each time point. Figure 4C is the ratio of these concentrations. Figure 4D is the pH of the samples taken at each time point as gastric emptying.
[0150] As shown by these results, it is believed that when agar and a thickener that inhibits gastric emptying of protein are contained, the gastric emptying promoting effect of protein by agar is preferentially expressed. That is, the composition of the present invention may contain both agar and a thickener that exhibits a stomach emptying inhibitory effect of protein, and when both are contained in the same content ratio, it is considered that the stomach emptying promoting effect of protein by agar is preferentially expressed. Therefore, when the composition of the present invention contains both agar and a thickener that exhibits a stomach emptying inhibitory effect of protein, the composition may be used as a composition for promoting stomach emptying of protein.
[0151] In addition, in consideration of the time when the gastric emptying promoting effect of the protein was confirmed in the above results, the gastric emptying promoting effect of the protein is considered to be effectively exerted, for example, within 150 minutes, particularly within 130 minutes, more particularly within 120 minutes, and even more particularly within 110 minutes from the time when the composition reaches the stomach. That is, the composition of the present invention containing both agar and carrageenan may be used to promote gastric emptying, for example, within 150 minutes, particularly within 130 minutes, more particularly within 120 minutes, and even more particularly within 110 minutes from the time when the target protein reaches the stomach.
[0152] 13.5 Example 4
[0153] Composition samples (Composition 4-1 and Composition 4-2) having the compositions and properties shown in Tables 4A to 4C below were prepared.
[0154] [Table 4]
[0155] Milk caseinate sodium powder (Tatsua), milk caseinate calcium powder (Tatsua), or soy protein (Fuji Oil), mineral mixture (Tomita Pharmaceutical), and vitamin raw material (DSM) were dissolved and mixed in hot water, and then adjusted fat (Taiyo Yushi) was added and homogenized. Powdered sugar (Matsutani Chemical Industry) was then added, and some samples were mixed with each thickener raw material dissolved in hot water, agar A [jelly strength: 300g / cm 2
[0113] (manufactured by Ina Food Industry Co., Ltd.), guar gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.), and xanthan gum (manufactured by San-Ei Gen F.F.I. Co., Ltd.) were added and mixed. The raw material compositions thus obtained were aseptically filled into containers after sterilization at 150°C for 4 seconds or more for composition 4-1, and were filled into containers after retort sterilization at 120°C for 4 minutes or more for composition 4-2, to prepare liquid compositions having the nutritional compositions shown in Table 4B.
[0156] The protein and carbohydrate concentrations of the prepared composition samples were measured as described in 9.1 above. Furthermore, the carbohydrate / protein ratio was calculated. The pH of the samples was also measured at each time point. The results are shown in Figures 5A-5D. Figure 5A is a graph showing the protein concentration at each time point. Figure 5B is a graph showing the carbohydrate concentration at each time point. Figure 5C is the ratio of these concentrations. Figure 5D is the pH of the samples taken at each time point as gastric emptying.
[0157] As shown by these results, it is believed that when agar and a thickener (such as guar gum) that inhibits the gastric emptying of protein are contained, the gastric emptying promoting effect of agar is preferentially expressed. That is, the composition of the present invention may contain both agar and a thickener that exhibits a stomach emptying inhibitory effect of protein, and when both are contained in the same content ratio, it is considered that the stomach emptying promoting effect of protein by agar is preferentially expressed. Therefore, when the composition of the present invention contains both agar and a thickener that exhibits a stomach emptying inhibitory effect of protein, the composition may be used as a composition for promoting stomach emptying of protein.
Claims
1. A protein gastric emptying regulating composition comprising agar, carrageenan, or both.
2. The composition for regulating protein gastric emptying according to claim 1 , further comprising a protein.
3. 3. The composition for regulating protein gastric emptying according to claim 1 or 2, wherein the total protein content is from 0.1% by mass to 20% by mass based on the total mass of the composition for regulating protein gastric emptying.
4. 3. A composition for regulating protein gastric emptying described in claim 1 or 2, wherein the total content of agar and carrageenan is 0.01% by mass or more relative to the total mass of the composition for regulating protein gastric emptying.
5. 3. The composition for regulating protein gastric emptying according to claim 1 or 2, wherein the composition is a flowable composition having a viscosity allowing spontaneous dripping.
6. The composition comprises agar, and The composition is a composition for promoting gastric emptying of protein. A composition for regulating protein gastric emptying according to claim 1 or 2.
7. The composition for regulating protein gastric emptying according to claim 6 , wherein the composition is a composition for promoting muscle synthesis and / or incretin secretion.
8. The composition comprises carrageenan and The composition is a composition for inhibiting gastric emptying of protein. A composition for regulating protein gastric emptying according to claim 1 or 2.
9. The composition for regulating protein gastric emptying according to claim 8 , wherein the composition is for reducing kidney burden and / or for sustaining a feeling of fullness.
10. agar, carrageenan, or both; It contains protein and gastric emptying of the protein is modulated by the agar, carrageenan, or both; Fluid nutritional composition.
11. The content of the protein relative to the total mass of the composition is 0.1% by mass to 20% by mass, The total content of the agar, carrageenan, or both of them relative to the total mass of the composition is 0.01% by mass or more; 11. The fluid nutritional composition of claim 10.
12. A composition comprising agar, the composition being at least one selected from the group consisting of a composition for promoting muscle synthesis and a composition for promoting incretin secretion.
13. A composition comprising carrageenan and being at least one type selected from the group consisting of a composition for reducing kidney burden and a composition for maintaining satiety.
Citation Information
Patent Citations
Gastric emptying rate inhibitor containing modified defatted soybeans as active ingredient
JP2021029198A