A composition for promoting bone health and bone formation, its use and products

By combining 2'-fucosylated lactose, osteopontin, and calcium sources in a specific ratio, the resulting composition solves the problem of low calcium intake and absorption efficiency, achieving the effect of promoting bone health and bone formation, and is suitable for a variety of calcium supplements.

CN119924527BActive Publication Date: 2025-12-30BIOSTIME (CHANGSHA) NUTRITION FOOD CO LTD
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Patent Information

Application Number
CN202510332621.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-03-20
Publication Date
2025-12-30
Estimated Expiration
2045-03-20

AI Technical Summary

Technical Problem

In the existing technology, the application of 2'-fucosylated lactose and osteopontin in food has not been fully optimized, resulting in low calcium intake and absorption efficiency, and failing to effectively promote bone health and bone formation.

Method used

A composition is provided, comprising 2'-fucosylated lactose, osteopontin, and a calcium source, which, through specific ratio compounding, form a composition with significant synergistic effects for the preparation of calcium supplements.

Benefits of technology

It significantly improves calcium absorption efficiency, enhances bone density, prevents and treats osteoporosis, promotes bone formation and development, and is suitable for calcium supplementation needs of different populations.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application provides a composition for promoting bone health and bone formation, and application and products thereof, and belongs to the field of food. The composition of the application is composed of 2'-fucosyllactose, osteopontin and a calcium source, wherein the osteopontin is 1-5 parts, the 2'-fucosyllactose is 1-50 parts and the calcium source is 0.05-50 parts by weight. The composition of the application shows a good synergistic effect in promoting calcium absorption, and can be used for increasing bone density, preventing and treating osteoporosis and the like.
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Description

Technical Field

[0001] This invention belongs to the food field, specifically relating to a composition that promotes calcium absorption and its applications and products. Background Technology

[0002] Calcium is an essential mineral for the human body. Calcium intake plays a crucial role in maintaining normal bone density, reducing fractures, promoting adolescent development, and lowering the risk of osteoporosis in the elderly. Calcium deficiency can be caused by long-term malnutrition, abnormal calcium metabolism, and other factors, with typical symptoms varying at different stages. In infants and children, calcium deficiency may lead to problems such as bald patches on the back of the head, night sweats, night terrors, delayed teething, delayed walking, milk aversion, and indigestion. If not supplemented in time, it may lead to rickets, including square head, X-shaped legs, O-shaped legs, and rib flaring. In adolescents during their growth and development period, calcium deficiency may cause slow height growth, poor tooth development, leg cramps, and symptoms such as increased allergies and susceptibility to colds. In adults and the elderly, calcium deficiency may induce symptoms such as lower back pain, irritability, and weakness in the limbs, accompanied by leg cramps, insomnia, and vivid dreams. Pregnant and lactating women have a relatively higher calcium requirement; calcium deficiency may lead to loose teeth, leg cramps, preeclampsia, and affect fetal calcium absorption.

[0003] For people with calcium deficiency, it is advisable to consume calcium-rich foods daily, such as dairy products, soy products, animal liver, and kelp, to alleviate the problems caused by calcium deficiency. However, calcium is not absorbed efficiently after ingestion, which means that to achieve the desired calcium supplementation effect, the actual intake needs to be much higher than the required amount. For ingredients with low calcium content, a larger dose is required to obtain the same amount of calcium.

[0004] 2'-Fucosyllactose (2'-FL) is an oligosaccharide widely found in breast milk and is therefore commonly used as a food ingredient, especially in infant formula. 2'-Fucosyllactose possesses anti-infective, antioxidant, anti-inflammatory, gut microbiota-improving, and gut microbiota-metabolic composition-influencing effects.

[0005] Osteopontin (OPN) is a glycosylated protein widely distributed in the extracellular matrix. OPN is an important bone matrix protein closely related to bone formation and development. Osteopontin is present in high concentrations in breast milk (averaging approximately 138 mg / L) and is an important immunologically active protein in breast milk. Osteopontin in breast milk is also known as lactopontin or breast osteopontin. The glycosylation modification of OPN is mainly O-glycans, with a high proportion of sialylation; therefore, it can also be called a sialic acid glycoprotein.

[0006] Osteopontoxin activity can directly reach the intestines, enhancing the intestinal protective barrier function and achieving systemic immune protection. Osteopontoxin levels are very high in neonatal umbilical cord blood plasma and 3-month-old infant plasma, approximately 7-10 times higher than in adults, suggesting a close relationship with early childhood growth and development.

[0007] In the prior art, the application of 2'-fucosylated lactose and osteopontin in food is relatively widespread. For example, patent application CN202410402081.1 describes that Bifidobacterium longum subsp. i772, 2'-fucosylated lactose, lactose-N-neotetrasaccharide, and lutein have a synergistic effect in promoting bone growth and development. This composition can effectively alleviate ocular cell apoptosis caused by eye fatigue and can be applied to infant formula, children's formula, fermented milk, and health food. Patent application CN202111219519.5 discloses a composition for promoting growth and development, comprising osteopontin, zinc-enriched yeast, optional nutritional components, and optional excipients. By weight, the osteopontin is 0.1-99.9 parts and the zinc-enriched yeast is 0.1-99.9 parts. By using the scientific combination of various raw material components such as osteopontin, zinc-enriched yeast, and lactoferrin, it has the effects of promoting growth and development and enhancing the body's immunity.

[0008] However, current technologies are not perfect for developing the above components, and there is still much room for optimization. Summary of the Invention

[0009] To address the aforementioned problems, the present invention provides a composition for promoting bone health and bone formation, and its application.

[0010] On the one hand, the present invention provides:

[0011] A composition for promoting bone health and bone formation, comprising 2'-fucosylated lactose, osteopontin, and a calcium source, wherein the composition comprises, by weight, 1-5 parts osteopontin, 1-50 parts 2'-fucosylated lactose, and 0.05-50 parts calcium source.

[0012] Based on the above ranges, the amount of each component in the composition may be selected from any combination of the following ranges:

[0013] (1) The osteopontin can be 1-5 parts, 1-2 parts, 1-3 parts, 1-4 parts, 2-3 parts, 2-4 parts, 3-4 parts, 3-5 parts, 2-5 parts, 1.5-3.5 parts, 1.5-2.5 parts, 1.5-4.5 parts, 1.3-3.8 parts, 1.2-4.5 parts;

[0014] (2) The 2'-fucosylated lactose may be 1-50 parts, 1-40 parts, 1-30 parts, 1-20 parts, 1-10 parts, 1-5 parts, 1-8 parts, 5-18 parts, 10-50 parts, 10-40 parts, 10-30 parts, 10-20 parts, 10-15 parts, 16-18 parts, 20-50 parts, 20-40 parts, 20-30 parts, 30-50 parts, 30-40 parts, 30-45 parts, 30-48 parts, 25-45 parts, 35-40 parts, 35-38 parts, 38-40 parts, or 35.5-45.5 parts;

[0015] (3) The calcium source may be 0.05-50 parts, 0.05-40 parts, 0.05-30 parts, 0.05-20 parts, 0.05-10 parts, 0.05-50 parts, 1-50 parts, 1-40 parts, 1-30 parts, 1-20 parts, 1-10 parts, 1-5 parts, 1-8 parts, 3-5 parts, 3-10 parts, 3-14 parts, 5-14 parts, 5-50 parts, 5 -40 servings, 5-30 servings, 5-20 servings, 5-10 servings, 10-50 servings, 10-40 servings, 10-30 servings, 10-20 servings, 10-15 servings, 20-50 servings, 20-40 servings, 20-30 servings, 30-50 servings, 30-40 servings, 30-45 servings, 30-48 servings, 25-45 servings, 35-40 servings, 35-38 servings, 38-40 servings.

[0016] Preferably, the composition comprises, by weight, 1 part osteopontin, 5-18 parts 2'-fucosylated lactose, and 3-14 parts calcium source.

[0017] Preferably, the composition comprises, by weight, 1 part osteopontin, 16-18 parts 2'-fucosylated lactose, and 3-5 parts calcium source.

[0018] Preferably, the composition comprises, by weight, 1 part osteopontin, 16 parts 2'-fucosylated lactose, and 5 parts calcium source.

[0019] Preferably, the composition comprises, by weight, 1 part osteopontin, 18 parts 2'-fucosylated lactose, and 3 parts calcium source.

[0020] Preferably, the composition comprises, by weight, 1 part osteopontin, 5 parts 2'-fucosylated lactose, and 14 parts calcium source.

[0021] The calcium source is selected from any one or more of calcium carbonate, calcium gluconate, calcium citrate, calcium lactate, L-calcium lactate, calcium hydrogen phosphate, calcium L-threonate, calcium glycine, calcium aspartate, calcium citrate malate, calcium acetate, calcium chloride, tricalcium phosphate, calcium vitamin E succinate, and calcium glycerophosphate.

[0022] The calcium source in the composition may exist independently or in combination with other components, such as conjugates with casein, conjugates with polypeptides, conjugates with casein phosphopeptides, conjugates with α-lactalbumin, etc. The calcium source content in the composition of the present invention is calculated based on the calcium ion content in the conjugate / composition.

[0023] For example, the calcium source of the present invention may be a milk mineral salt, each 1g of milk mineral salt may contain 0.269g of calcium, or as is known in the art, the calcium content of the milk mineral salt raw material is 23%wt-28%wt.

[0024] For example, the calcium source can be achieved by directly adding a background, which includes, but is not limited to, skim milk, whey protein concentrate, lactose, and other raw materials; or it can be a combination of these backgrounds and mineral salts. For instance, in certain products, the calcium content source can include any one or more of the aforementioned backgrounds combined with any one or more of calcium carbonate and tricalcium phosphate. In such examples, the actual amount of background or the combination of background and mineral salts used to provide the calcium source is higher than the aforementioned amount of calcium source added. A more specific example application could be staged milk powder. Those skilled in the art can select the calcium source according to actual needs, such as choosing a combination of background and calcium carbonate in stage 1 or stage 3 milk powder, or a combination of background, calcium carbonate, and tricalcium phosphate in stage 2 milk powder. In practical applications, the content of mineral calcium salts may also be limited, such as limiting the proportion of calcium carbonate in the combination of background and mineral salts (e.g., mass percentage < 50%). Adjustments to the form and amount of raw materials made by those skilled in the art without departing from the technical concept of this invention are all within the scope of protection of this invention.

[0025] When the calcium source in the composition of the present invention is calcium phosphate, the preferred amount of calcium phosphate added is 10-40 parts by weight, and more preferably 12.9-36.2 parts by weight.

[0026] When the calcium source in the composition of the present invention is calcium citrate, the preferred amount of calcium citrate added is 10-30 parts by weight, and more preferably 14.3-23.8 parts by weight.

[0027] When the calcium source in the composition of the present invention is calcium carbonate, the preferred amount of calcium carbonate added is 5-35 parts by weight, and more preferably 7.5-35 parts by weight.

[0028] Preferably, the calcium source is selected from any one or more of the following: animal milk, seafood, nuts, soy products, and leafy green vegetables.

[0029] The animal milk mentioned includes, but is not limited to, cow's milk and sheep's milk.

[0030] The seafood products mentioned include, but are not limited to: fish, shrimp, crab, and seaweed.

[0031] On the other hand, the present invention provides the use of the composition in the preparation of calcium supplement products.

[0032] Preferably, the calcium supplement can be an oral product.

[0033] The effects of the calcium supplement products mentioned include, but are not limited to: increasing bone density, increasing blood calcium levels, increasing bone calcium levels, and preventing or treating osteoporosis.

[0034] Based on the above, the present invention also protects the calcium supplement products containing the aforementioned composition.

[0035] According to the general understanding of those skilled in the art, the calcium supplement product may also include food excipients or pharmaceutical excipients.

[0036] The food additives mentioned include, but are not limited to, any one or more of the following: gelling agents, sweeteners, acidulants, humectants, food flavorings, nutritional supplements, thickeners, emulsifiers, and dispersants.

[0037] The pharmaceutical excipients include, but are not limited to, any one or more of the following: fillers, binders, disintegrants, lubricants, emulsifiers, antioxidants, antibacterial agents, isotonic modifiers, suspending agents, solubilizers, cosolvents, preservatives, and flavoring agents.

[0038] The calcium supplement products mentioned include, but are not limited to, any one or more of the following: oral liquids, modified milk powders, gel candies, hard candies, dairy beverages, gluten products, soft drinks, and fruit juices.

[0039] This invention also provides a general method for preparing a calcium supplement product, comprising mixing the composition with excipients. Those skilled in the art can adjust the excipient formulation and preparation conditions according to the specific purpose using conventional preparation methods.

[0040] The beneficial effects of this invention are:

[0041] This invention provides a composition that promotes calcium absorption by compounding the active ingredients. The components have a significant synergistic effect and exhibit good results. It has great application value in improving bone density and preventing and treating osteoporosis. Detailed Implementation

[0042] The present invention will be further described in detail below with reference to specific embodiments. The following embodiments are not intended to limit the present invention, but only to illustrate the present invention. Unless otherwise specified, the experimental methods used in the following embodiments are generally performed under conventional conditions. Unless otherwise specified, the materials and reagents used in the following embodiments are commercially available.

[0043] The source information of some raw materials in the examples is as follows:

[0044]

[0045] Those skilled in the art should know that the specific source of raw materials can be replaced by conventional means, and the purchase channel can be selected according to the actual situation. Therefore, the source of raw materials in this invention is only shown as a feasible solution and is not intended to limit the actual application of this invention.

[0046] Example 1

[0047] By weight, it includes 1 part osteopontin, 16 parts 2'-fucosylated lactose, and 5 parts calcium source.

[0048] In this embodiment, the calcium source is calcium phosphate, with a calcium content of 38.71%, and the actual amount of calcium phosphate used is approximately 12.9 parts.

[0049] Example 2

[0050] By weight, it includes 1 part osteopontin, 18 parts 2'-fucosylated lactose, and 3 parts calcium source.

[0051] In this embodiment, the calcium source is calcium citrate, with a calcium content of 24.1% and an actual usage of approximately 12.5 parts.

[0052] Example 3

[0053] By weight, it includes 1 part osteopontin, 5 parts 2'-fucosylated lactose, and 14 parts calcium source.

[0054] In this embodiment, the calcium source is calcium carbonate, with a calcium content of 40% and an actual usage of 35 parts.

[0055] Example 4

[0056] Referring to Example 1, the calcium source was replaced with calcium citrate, and the actual amount used was 20.8 parts.

[0057] Example 5

[0058] Referring to Example 2, the calcium source was replaced with calcium carbonate, and the actual amount used was 7.5 parts.

[0059] Example 6

[0060] Referring to Example 3, the calcium source was replaced with calcium phosphate, and the actual amount used was 36.2 parts.

[0061] Example 1 of the effect experiment: animal intervention experiment

[0062] Animal intervention experiments were conducted using existing standard validation protocols, specifically including the following:

[0063] Experimental animals: 4-week-old male C56BL / 6 mice, weighing (20±2)g, provided by Shanghai Slack Laboratory Animal Co., Ltd.

[0064] Grouping and Feeding: Mice were acclimatized for one week (temperature 23±2℃, humidity 50±2%, light and dark alternation every 12 hours). After acclimatization, they were randomly divided into groups (n=7) and gavage samples were administered as follows:

[0065] In the examples and comparative groups, the corresponding compositions were administered by gavage at a dose of 500 mg / kg daily, while the control group was administered a placebo by gavage. The gavage frequency was once a day, at approximately 10:00 AM each day, for 8 weeks.

[0066] Whole-body bone mineral density (BMD, mg / cm³) of experimental mice was measured using dual-energy X-ray absorptiometry before administration of the drug via gavage (0w) and at the end of the experiment (8w). 2 The test results are as follows:

[0067] Group 0w 8w control group 60.3±2.4 61.4±3.1 Example 1 61.1±3.5 <![CDATA[76.5±4.1** ## ]]> Example 2 60.8±2.8 <![CDATA[74.2±2.5** ## ]]> Example 3 62.0±3.7 <![CDATA[70.6±2.3** # ]]> Example 4 61.7±2.0 <![CDATA[75.8±3.9** ## ]]> Example 5 61.9±1.6 <![CDATA[73.9±3.4** ## ]]> Example 6 60.5±1.9 <![CDATA[71.7±4.7** ## ]]>

[0068] Among them, compared with 0w: ** indicates P < 0.01; compared with the control group, # indicates P < 0.05, and ## indicates P < 0.01.

[0069] The data above show that the compositions of Examples 1-6 significantly increased bone density in experimental mice at 8 weeks compared to the control group, indicating a certain bone formation promoting effect. Examples 1-2 and 4-6 showed more significant differences compared to the control group.

[0070] Experimental Example 2: Calcium-deficient animal model experiment

[0071] A calcium-deficient animal model was constructed based on existing technologies to verify the calcium supplementation effect of the present invention, as detailed below:

[0072] Experimental animals: 21-day-old SD rats, weighing 50±5g, provided by Shanghai Slack Laboratory Animal Co., Ltd.

[0073] Model construction method: The model was constructed by feeding the model with a low-calcium diet, which is defined as a diet containing 20mg of calcium per 100g.

[0074] Group the data as follows (n=7):

[0075] Blank control group: fed with ordinary rat feed and free access to water;

[0076] Model group: fed low-calcium feed, with free access to water;

[0077] Experimental group: fed low-calcium feed, with free access to water, and administered the corresponding compositions from each example by gavage at a dose of 500 mg / kg daily.

[0078] Blood samples were collected from the heart of rats in each group at the end of week 4 (4w) and week 6 (6w) after drug administration, and the blood calcium content (mM) was measured using a commercially available calcium assay kit.

[0079] Blood was collected from mice at week 8 (8 weeks) after drug administration; whole-body bone mineral density (BMD, mg / cm³) was measured using dual-energy X-ray absorptiometry. 2 ) Detection; rat femur was used for bone calcium (mg / g) determination.

[0080] The determination of bone calcium in rats was performed using the EDTA titration method on femoral bone ash, referencing existing techniques. The specific steps included: after femoral bone ash ash was collected, 0.05 g of the ash sample was dissolved in 1 mL of 6 mol / L HCl, followed by 20 mL of pure water. 2 mL of 2 mol / L NaOH was added to adjust the pH to neutral, then 50 μL of 10 g / L KCN and 100 μL of 0.05 mol / L sodium citrate were added. After mixing, 2 mL of NaOH and 1-2 drops of calcifera red indicator were added, and titration was performed with 0.01 mol / L EDTA until the red indicator turned pure blue, which was the endpoint. The change in bone calcium was characterized by the percentage of bone calcium in the femoral bone ash, calculated as follows:

[0081] Bone calcium content (mg / g) = V1 × C1 × 40 × 1000 / M1;

[0082] Where V1 is the EDTA titration volume in mL; C1 is the concentration of the EDTA solution in mol / L; and M1 is the sample volume of bone ash used for titration in g.

[0083] Result data:

[0084] (1) The results of serum calcium (mM) measurement are as follows:

[0085] Group 4w 6w 8w Blank control group <![CDATA[2.48±0.14 ## ]]> <![CDATA[2.51±0.11 ### ]]> <![CDATA[2.49±0.07 ### ]]> Model group 2.13±0.09** 1.95±0.13*** 1.24±0.15*** Example 1 <![CDATA[2.52±0.14 ## ]]> <![CDATA[2.58±0.12 ### ]]> <![CDATA[2.53±0.05 ### ]]> Example 2 <![CDATA[2.47±0.16 ## ]]> <![CDATA[2.45±0.17 ### ]]> <![CDATA[2.39±0.04 ### ]]> Example 3 <![CDATA[2.45±0.08 ## ]]> <![CDATA[2.47±0.12 ### ]]> <![CDATA[2.34±0.23 ### ]]> Example 4 <![CDATA[2.50±0.11 ## ]]> <![CDATA[2.44±0.20 ### ]]> <![CDATA[2.46±0.11 ### ]]> Example 5 <![CDATA[2.39±0.15 ## ]]> <![CDATA[2.36±0.07 ### ]]> <![CDATA[2.45±0.14 ### ]]> Example 6 <![CDATA[2.43±0.17 ## ]]> <![CDATA[2.34±0.24 ### ]]> <![CDATA[2.40±0.18 ### ]]>

[0086] Compared with the blank control group, ** indicates P < 0.01, *** indicates P < 0.001; compared with the model group, ## indicates P < 0.01, ### indicates P < 0.001.

[0087] The data above show that the blood calcium concentration in the model group was reduced, and the compositions of Examples 1-6 can restore the blood calcium reduction caused by the low-calcium diet.

[0088] (2) Bone mineral density (BMD, mg / cm³) 2 The measurement results are as follows:

[0089] Group 8w Blank control group <![CDATA[66.3±2.6 ## ]]> Model group 51.4±3.1** Example 1 <![CDATA[79.4±3.5** ### ]]> Example 2 <![CDATA[78.2±1.6** ### ]]> Example 3 <![CDATA[73.5±1.8* ### ]]> Example 4 <![CDATA[78.8±2.4** ### ]]> Example 5 <![CDATA[77.9±2.1** ### ]]> Example 6 <![CDATA[76.7±3.7** ### ]]>

[0090] Among them, ** indicates P < 0.01 compared with the blank control group; ## indicates P < 0.01 compared with the model group, and ### indicates P < 0.001.

[0091] The data above show that the compositions of Examples 1-6 can not only alleviate the decrease in bone density caused by calcium deficiency, but also further promote bone development and increase bone density.

[0092] (3) The results of bone calcium (mg / g) determination are as follows:

[0093] Group 8w Blank control group <![CDATA[187.5±18.7 ## ]]> Model group 138.6±22.4** Example 1 <![CDATA[198.4±13.2 ## ]]> Example 2 <![CDATA[192.7±15.6 ## ]]> Example 3 <![CDATA[189.5±18.4 ## ]]> Example 4 <![CDATA[191.3±17.1 ## ]]> Example 5 <![CDATA[192.1±20.6 ## ]]> Example 6 <![CDATA[186.4±16.4 ## ]]>

[0094] Among them, ** indicates P < 0.01 compared with the blank control group; and ## indicates P < 0.01 compared with the model group.

[0095] The results of bone calcium assay show that the composition of the present invention can alleviate the problem of reduced bone calcium content in the model group.

[0096] In summary, the compositions in the embodiments of this invention can all achieve good effects in promoting calcium absorption and alleviating calcium deficiency symptoms. To better demonstrate the effects of this invention, the following comparative examples were also verified:

[0097] Comparative Example 1

[0098] A composition comprising, by weight, 1 part osteopontin, 16 parts fructooligosaccharides, and 5 parts calcium source, wherein the calcium source is calcium phosphate.

[0099] Comparative Example 2

[0100] A composition comprising, by weight, 1 part lactoferrin, 16 parts 2'-fucosylated lactose and 5 parts calcium source, wherein the calcium source is calcium phosphate.

[0101] Comparative Example 3

[0102] A composition comprising, by weight, 16 parts of 2'-fucosylated lactose and 5 parts of a calcium source, wherein the calcium source is calcium phosphate.

[0103] Comparative Example 4

[0104] A composition comprising, by weight, 1 part osteopontin and 5 parts calcium source, wherein the calcium source is calcium phosphate.

[0105] Comparative Example 5

[0106] A composition comprising, by weight, 16 parts osteopontin, 1 part 2'-fucosylated lactose, and 5 parts calcium source, wherein the calcium source is calcium phosphate.

[0107] Comparative Example 6

[0108] A single calcium source (calcium phosphate) was used as a comparative example 6.

[0109] The comparative examples were verified by referring to the effect experiment examples 1-2 (conducted simultaneously with the examples, using the same blank control group and model group). It should be noted that when administering the formula of the comparative examples by gavage, the actual gavage volume of comparative examples 3-4 was ensured to be consistent with the gavage volume of each individual component as in example 1, rather than the total amount.

[0110] Animal intervention experiment bone mineral density (BMD, mg / cm³) 2 The test results are as follows:

[0111] Group 0w 8w Comparative Example 1 61.5±0.16 <![CDATA[67.7±0.14 **##AA ]]> Comparative Example 2 61.4±0.08 <![CDATA[68.5±0.21 **##AA ]]> Comparative Example 3 61.8±0.13 <![CDATA[63.9±0.15 *#AA ]]> Comparative Example 4 62.1±0.04 <![CDATA[65.2±0.06 *#AA ]]> Comparative Example 5 61.7±0.23 <![CDATA[63.4±0.16 *#AA ]]> Comparative Example 6 61.2±0.15 <![CDATA[61.3±0.07 AA ]]>

[0112] Among them, compared with 0w: * indicates P < 0.05, ** indicates P < 0.01; compared with the control group, # indicates P < 0.05, ## indicates P < 0.01; compared with Example 1, AA indicates P < 0.01.

[0113] It can be seen that in the animal intervention experiments, the effect data of Comparative Examples 1-6 were all worse than those of Example 1, and to some extent reflected the synergistic effect of the components in the composition of Example 1.

[0114] The results of the calcium-deficient animal model experiment are as follows:

[0115] (1) The results of serum calcium (mM) measurement are as follows:

[0116] Group 4w 6w 8w Comparative Example 1 <![CDATA[2.38±0.14 ## ]]> <![CDATA[2.39±0.28 ### ]]> <![CDATA[2.44±0.25 ### ]]> Comparative Example 2 <![CDATA[2.41±0.26 ## ]]> <![CDATA[2.46±0.15 ### ]]> <![CDATA[2.41±0.17 ### <!-- 7 -->]]> Comparative Example 3 <![CDATA[2.39±0.31 ## ]]> <![CDATA[2.44±0.04 ### ]]> <![CDATA[2.51±0.25 ### ]]> Comparative Example 4 <![CDATA[2.51±0.02 ## ]]> <![CDATA[2.53±0.06 ### ]]> <![CDATA[2.49±0.14 ### ]]> Comparative Example 5 <![CDATA[2.50±0.17 ## ]]> <![CDATA[2.32±0.14 ### ]]> <![CDATA[2.31±0.07 ### ]]> Comparative Example 6 2.42±0.24 <![CDATA[2.51±0.15 ### ]]> <![CDATA[2.39±0.22 ### ]]>

[0117] In this context, compared to the model group, ## indicates P < 0.01, and ### indicates P < 0.001.

[0118] The compositions in Comparative Examples 1-6 also showed an increase in blood calcium levels in a calcium-deficient rat model, with significant differences compared to the model group, and the overall levels were roughly the same as in Example 1.

[0119] (2) Bone mineral density (BMD, mg / cm³) 2 The measurement results are as follows:

[0120] Comparative Example 8w Comparative Example 1 <![CDATA[65.1±2.2 ##AA ]]> Comparative Example 2 <![CDATA[62.4±3.4 ##AA ]]> Comparative Example 3 <![CDATA[61.8±0.6 #AA ]]> Comparative Example 4 <![CDATA[60.3±1.7 #AA ]]> Comparative Example 5 <![CDATA[64.8±2.5 ##AA ]]> Comparative Example 6 <![CDATA[53.7±1.9 AAA ]]>

[0121] In this context, compared with the model group, # indicates P < 0.05, and ## indicates P < 0.01; compared with Example 1, AA indicates P < 0.01, and AAA indicates P < 0.001.

[0122] As can be seen from the above, the composition in the comparative example can also alleviate bone density in calcium-deficient rats to some extent, but the effect is significantly worse than that in Example 1.

[0123] (3) The results of bone calcium (mg / g) determination are as follows:

[0124] Comparative Example 8w Comparative Example 1 <![CDATA[161.4±12.0 #AA ]]> Comparative Example 2 <![CDATA[165.2±18.6 #AA ]]> Comparative Example 3 <![CDATA[156.8±15.4 #AA ]]> Comparative Example 4 <![CDATA[157.6±16.1 #AA ]]> Comparative Example 5 <![CDATA[158.1±13.8 #AA ]]> Comparative Example 6 <![CDATA[152.9±10.7 #AA ]]>

[0125] In this context, # indicates P < 0.05 compared to the model group; and AA indicates P < 0.01 compared to Example 1.

[0126] Based on the bone calcium data, it can be seen that the composition in the comparative example is far less effective than that in Example 1 in alleviating bone calcium levels in the rat model.

[0127] In summary, the components of this invention have a significant synergistic effect in alleviating calcium deficiency symptoms in a rat model, and have an unexpected technical effect, particularly in increasing bone density.

[0128] Application Example 1: A Gel Candy that Promotes Calcium Absorption

[0129] It includes any one of the compositions in Examples 1-6, and also includes commonly used gel candy excipients: gelling agents, sweeteners, acidulants, humectants, food flavorings, etc.

[0130] The gel candy provided in this application example has high consumer acceptance, especially among children with high calcium needs, as it effectively promotes calcium absorption and bone development.

[0131] Application Example 2: A Formulated Powder to Promote Calcium Absorption

[0132] The formulation includes any one of the compositions in Examples 1-6, and also includes other excipients for the powder preparation: concentrated whey protein powder, skim milk powder, whole milk powder, galactooligosaccharides, etc. The powder preparation is carried out according to conventional methods in the prior art. The powder preparation can be modified milk powder or modified protein powder. The resulting powder preparation has a good ability to promote calcium absorption and is suitable for infants, the elderly, and other people who need calcium supplementation.

[0133] Application Example 3: An oral liquid that promotes calcium absorption

[0134] The composition includes any one of Examples 1-6, and also includes oral liquid excipients: maltitol solution, xylitol, corn oil, gum arabic, citric acid, xanthan gum, flavoring, and purified water.

[0135] This oral liquid is easy to take, tastes good, is widely accepted by the population, and can promote calcium absorption.

[0136] The above embodiments and application examples are only used to illustrate the present invention and are presented as some examples. They are not intended to limit the present invention. Any adjustments, substitutions, or optimizations of conventional technical means made by those skilled in the art without departing from the technical concept of the present invention are still within the scope of protection of the present invention.

Claims

1. A composition for promoting bone health and bone formation, characterized by, The composition is composed of 2'-fucosyllactose, osteopontin and calcium source, wherein the osteopontin is 1 part, the 2'-fucosyllactose is 16-18 parts and the calcium source is 3-5 parts by weight; The calcium source is selected from any one or more of calcium carbonate, calcium gluconate, calcium citrate, calcium lactate, calcium hydrogen phosphate, calcium L-threonate, calcium glycinate, calcium aspartate, calcium citrate malate, calcium acetate, calcium chloride, tricalcium phosphate, vitamin E calcium succinate and calcium glycerophosphate.

2. Use of the composition of claim 1 in the preparation of a calcium supplement product.

3. Use according to claim 2, characterized in that, The calcium supplement product is an oral product.

4. Use according to claim 3, characterized in that, The efficacy of the calcium supplement product includes increasing bone density, increasing blood calcium content and increasing bone calcium content.

5. A calcium supplement product comprising the composition of claim 1.

6. The calcium supplement product of claim 5, wherein, The calcium supplement product further comprises food adjuvants or pharmaceutical adjuvants.

7. The calcium supplement product of claim 6, wherein, The food adjuvant is selected from any one or more of gelling agents, sweeteners, acidifiers, moisture retainers, food essences, nutritional supplements, thickening agents, emulsifiers, dispersants.

8. The calcium supplement product of claim 6, wherein, The pharmaceutical adjuvant is selected from any one or more of fillers, binders, disintegrants, lubricants, emulsifiers, antioxidants, bacteriostatic agents, isotonicity adjusting agents, suspending agents, solubilizers, co-solvents, preservatives, flavoring agents.

9. The calcium supplement product of claim 5, wherein, The calcium supplement product is selected from any one or more of oral liquids, recombined milk powder, gummy candies, hard candies, milk beverages, gluten products, sodas, fruit juices.

10. A method of preparing a calcium supplement product, characterized by, The calcium supplement product is prepared by mixing the composition of claim 1 with adjuvants.

Citation Information

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