Composition for emotional relief and use thereof

Abstract

A composition for emotional relief includes lactic acid bacteria strains and a carrier. The lactic acid bacteria strains include isolated Bifidobacterium breveBBr-28, Bifidobacterium animalissubsp. lactisPS23, Bifidobacterium longumsubsp. infantisBR631 and Lacticaseibacillus paracaseiBR176, all of which are deposited at the Food Industry Research and Development Institute. A use of a lactic acid bacteria strain in preparing a composition for emotional relief is also disclosed.

Description

Technical Field

[0001] This invention relates to a composition and its use, and more particularly to a composition and its use for relieving mood. Prior Technology

[0002] The World Health Organization estimates that by 2030, depression will be the leading cause of socioeconomic burden globally. This means that with changing social structures, more people may suffer from depression, and the resulting socioeconomic burden will be even more severe. However, many people with depression may be unwilling to acknowledge their condition or resist treatment; therefore, the majority of people with depression do not receive adequate medical care.

[0003] Depression is a normal human emotion; for example, when encountering setbacks or unpleasant situations, people inevitably feel down. However, if the low mood is severe and lasts for a long time without being able to recover, or even gets out of control, it may develop into depression.

[0004] In light of this, there is an urgent need to develop a safe and long-term edible nutritional supplement with mood-soothing properties. Since lactic acid bacteria are generally considered safe, identifying compositions containing lactic acid bacteria strains with mood-soothing properties is a pressing objective. Summary of the Invention

[0005] The present invention provides a composition containing a strain of lactic acid bacteria, which has a physiological activity that soothes emotions. Therefore, the composition of the present invention can be used for the purpose of soothing emotions and exists in the form of a food composition or a pharmaceutical composition.

[0006] An embodiment of the present invention provides a composition for soothing emotions, comprising a strain of lactic acid bacteria with soothing activity and a carrier. The strain of lactic acid bacteria with soothing activity comprises isolated strains of *Bifidobacterium breve* BBr-28 (accession number BCRC 911254), *Bifidobacterium animalis subsp. lactis* PS23 (accession number BCRC 911251), *Bifidobacterium longum subsp. infantis* BR631 (accession number BCRC 911172), and *Lactobacillus paracasei* BR176 (accession number BCRC 911253), all of which are registered with the Food Industry Development Institute.

[0007] Another embodiment of the present invention relates to the use of a lactic acid bacteria strain in the preparation of a composition for soothing emotions, wherein the composition comprises a lactic acid bacteria strain having soothing activity and a carrier. The lactic acid bacteria strain having soothing activity comprises isolated *Bifidobacterium breve* strain BBr-28, accession number BCRC 911254; *Bifidobacterium animalis subsp. lactis* strain PS23, accession number BCRC 911251; *Bifidobacterium longum subsp. infantis* strain BR631, accession number BCRC 911172; and *Lacticaseibacillus paracasei* strain BR176, accession number BCRC 911253, all of which are registered at the Food Industry Development Institute.

[0008] The following detailed description, using specific embodiments and accompanying drawings, will make it easier to understand the purpose, technical content, features, and effects achieved by this invention. Simple Explanation of the Diagram

[0009] Figure 1a shows the experimental results of changes in serotonin levels in subjects before and after taking the composition of an embodiment of the present invention.

[0010] Figure 1b shows the experimental results regarding changes in serotonin levels before and after the subjects took the control group's composition.

[0011] Figure 2 shows the comparison of changes in serotonin levels after subjects took the composition of one embodiment of the present invention and the control group.

[0012] Figure 3 shows the test results of dopamine changes in subjects before and after taking the composition of an embodiment of the present invention. Implementation

[0013] The following details various embodiments of the present invention, illustrated in the accompanying drawings. Besides these detailed descriptions, the present invention can be widely implemented in other embodiments, and any easy substitutions, modifications, or equivalent changes to the described embodiments are included within the scope of the present invention and are subject to the claims. In the description of the specification, many specific details are provided to give the reader a more complete understanding of the present invention; however, the present invention may still be implemented even with some or all of these specific details omitted. Furthermore, well-known steps or elements are not described in the details to avoid unnecessarily limiting the present invention. Identical or similar elements in the drawings will be represented by the same or similar symbols. It is particularly important to note that the drawings are for illustrative purposes only and do not represent the actual size or number of elements; some details may not be fully drawn for the sake of simplicity.

[0014] Research on the effects of probiotics on human health is extensive. Generally speaking, strains that have specific effects on human health are called functional probiotics (Guidelines for the evaluation of probiotics in food; Report of joint FAO / WHO working group on drafting guidelines for the evaluation of probiotics in food; London Ontario, Canada April 30 and May 1, 2002: 1-7). It is important to note that the specific effects of these functional probiotics lie in the strain specificity rather than the species. That is, even the same species, if different strains, may have different effects, or even opposite effects.

[0015] The freeze-dried culture of the lactic acid bacteria strain described in this invention has been deposited with the Food Industry Development & Research Institute, located at No. 331, Food Rd., Hsinchu City, Taiwan. Detailed information regarding the deposit is shown in Table 1.

[0016] Table 1. Resident data of lactic acid bacteria strains strain name Classification Deposit number Deposit Date BBr-28 Bifidobacterium breve Bifidobacterium breve BCRC 911254 2024 / 12 / 10 PS23 Bifidobacterium animalis subsp. lactis Bifidobacterium animalissubsp. lactis BCRC 911251 2024 / 12 / 10 BR631 Bifidobacterium longum infant subspecies Bifidobacterium longumsubsp. infantis BCRC 911172 2023 / 02 / 20 BR176 Lactobacillus paracasei Lacticaseibacillus paracasei BCRC 911253 2024 / 12 / 10

[0017] The combination of lactic acid bacteria strains listed in Table 1 has physiological activity that can soothe emotions; therefore, the combination of the above-mentioned lactic acid bacteria strains can be used for the purpose of soothing emotions.

[0018] One embodiment of the present invention provides a composition for soothing emotions, comprising a strain of lactic acid bacteria with soothing activity and a carrier. In one embodiment, the lactic acid bacteria strain comprises the following isolated strains: *Bifidobacterium breve* BBr-28, accession number BCRC 911254; *Bifidobacterium animalis subsp. lactis* PS23, accession number BCRC 911251; *Bifidobacterium longum subsp. infantis* BR631, accession number BCRC 911172; and *Lacticaseibacillus paracasei* BR176, accession number BCRC 911253. All of the above strains are registered at the Food Industry Development Institute. For example, the ratio of each lactic acid bacteria powder can be 1:1:1:1, but is not limited to this; the ratio of each lactic acid bacteria powder can be designed to an appropriate ratio based on systematic experimental results. In one embodiment, the carrier can be a physiologically acceptable excipient or diluent. Alternatively, the carrier can be a pharmaceutically acceptable excipient or diluent.

[0019] In one embodiment, the effective viable count of the lactic acid bacteria strain in the composition of the present invention is greater than or equal to 1 × 10⁶ CFU / g; in a preferred embodiment, the effective viable count of the lactic acid bacteria strain in the composition of the present invention is equal to or greater than 5 × 10⁹ CFU / g. In one embodiment, the dosage form of the composition of the present invention may be tablets, capsules, or powder for convenient oral administration by the user. [Characteristics of the lactic acid bacteria strains of this invention:]

[0020] The taxonomic characteristics of the strain were confirmed based on 16S rRNA sequence analysis and API bacterial identification system analysis results. The morphological and general characteristics of the lactic acid bacteria strain of this invention are detailed in Table 2: Table 2. Morphological and general properties of the lactic acid bacteria strains of the present invention strain name Morphological characteristics Bifidobacterium breve BBr-28 strain 1. When cultured in MRS medium, the bacteria exhibit irregular shapes such as Y-shape, V-shape, or curved shape. The bacteria are small and usually appear alone, not in chains. 2. Gram-positive bacilli that do not produce spores, do not possess catalase, oxidase, or motility, grow in an absolutely anaerobic environment, with an optimal growth temperature of 37±1℃, and are facultative heterogeneous fermenting strains that do not produce gas during glucose metabolism. Bifidobacterium animalis subsp. lactis PS23 strain 1. When cultured in MRS medium, the bacteria exhibit irregular shapes such as Y-shape, V-shape, or curved shape, and usually appear alone rather than in chains. 2. Gram-positive bacilli that do not produce spores, do not possess catalase, oxidase, or motility, grow in an absolutely anaerobic environment, with an optimal growth temperature of 37±1℃, and are facultative heterogeneous fermenting strains that do not produce gas during glucose metabolism. Bifidobacterium longum infant subspecies BR631 strain 1. When cultured in MRS medium, the bacterial cells are short rod-shaped with an oval tail, usually appearing alone or in pairs of short chains. 2. Gram-positive bacilli that do not produce spores, do not possess catalase, oxidase, or motility, can grow in both aerobic and anaerobic environments, with the optimal growth temperature being 37±1℃. They are facultative heterogeneous fermenting strains and do not produce gas during glucose metabolism. Lactobacillus paracasei BR176 strain 1. When cultured in MRS medium, the bacteria are short rod-shaped with rounded ends, usually in chains, and occasionally appear singly or in pairs. 2. Gram-positive bacilli that do not produce spores, do not possess catalase, oxidase, or motility, can grow in both aerobic and anaerobic environments, with the optimal growth temperature being 37±1℃. They are facultative heterogeneous fermenting strains and do not produce gas during glucose metabolism. [Preparation of the lactic acid bacteria powder and composition of the present invention:]

[0021] The *Bifidobacterium breve* BBr-28 strain, *Bifidobacterium animalis* subsp. *lactobacter* PS23 strain, and *Bifidobacterium longum* subsp. *infant* strain BR631 strain of this invention were isolated from breast milk; *Lactobacillus paracasei* strain BR176 strain was isolated from infant feces. The isolated lactic acid bacteria strains were stored at -80°C with 20% glycerol. For use, 1% (v / v) inoculum was inoculated into Difco TMMRS (De Man, Rogosa and Sharpe) medium and cultured at 37°C for 20 hours. Subsequently, the four cultures were centrifuged at 4°C for 20 minutes, the supernatant was discarded, and the resulting precipitates (pellets) were freeze-dried to obtain the bacterial powder of each lactic acid bacteria strain. In one embodiment, the precipitate after centrifugation could be mixed with a protective carrier before freeze-drying to maintain better bacterial activity.

[0022] The above-mentioned lactic acid bacteria powder and carrier are mixed evenly to form the composition of the present invention, wherein the effective viable count of the lactic acid bacteria strain is equal to or greater than 5 × 10⁹ CFU / g. In one embodiment, the carrier may contain oligosaccharides, sugar alcohols, sodium carboxymethyl cellulose, ethyl cellulose, galactooligosaccharides, stearic acid, magnesium stearate, potato starch, or a combination thereof. For example, oligosaccharides may contain fructooligosaccharides, isomaltose oligosaccharides, xylooligosaccharides, stachyose, mannose, arabinose, or a combination thereof; sugar alcohols may contain erythritol, sorbitol, isomaltitol, xylitol, mannitol, or a combination thereof. [Physiological activity analysis of the composition of the present invention:]

[0023] Thirty participants were divided into two groups. One group took the capsules containing the composition of this invention twice daily, once between 2-3 PM and once two hours before bedtime, for two weeks. The other group, serving as a control group, took capsules containing only Bifidobacterium animalis subsp. lactis strain PS23 powder; all other administration methods were the same. Blood samples were collected from the participants before and after taking the compositions of the embodiments and control group to measure changes in serotonin levels. In the embodiment group, changes in dopamine levels were also measured. [(one)] [The effect of taking the composition of one embodiment of the present invention on serotonin:]

[0024] Serotonin, also known as 5-hydroxytryptamine (5-HT), is a monoamine neurotransmitter responsible for transmitting mood-related signals in the brain. Serotonin regulates emotional responses; a deficiency can lead to feelings of depression, sadness, and anxiety. Conversely, sufficient serotonin levels result in more stable moods, greater relaxation, and even feelings of happiness and well-being.

[0025] Before and two weeks after taking the compositions of the embodiments and control groups of this invention, approximately 5 ml of blood was collected from the subjects for serotonin testing. The collected blood was centrifuged to separate the serum. The serum was processed using serotonin ELISA kits (abnova) according to the manufacturer's instructions. After HRP (horseradish peroxidase) catalysis to produce TMB (3,3',5,5'-Tetramethyl-benzidine) colorimetric reaction, the absorbance was measured using an ELISA Reader at OD 450 nm, and the serotonin concentration was calculated using a standard curve.

[0026] Figure 1a shows the results of the test on changes in serotonin levels in subjects before and after taking the composition of an embodiment of the present invention. Figure 1b shows the results of the test on changes in serotonin levels in subjects before and after taking the composition of the control group. Figure 2 compares the changes in serotonin levels in subjects after taking the composition of an embodiment of the present invention and the control group. The values ​​are presented as Mean ± SD. Statistical analysis was performed using a paired t-test, and p < 0.05 was considered statistically significant.

[0027] As shown in Figures 1a and 1b, after two weeks of taking the compositions of both the embodiments of the present invention and the control group, the serotonin levels in the blood of the subjects increased significantly compared to before taking the compositions. Furthermore, comparing the changes in serotonin levels (i.e., the difference between serotonin levels before and after taking the composition of one embodiment of the present invention) with the control group, the increase in serotonin levels after taking the composition of one embodiment of the present invention was significantly greater than that in the control group, as shown in Figure 2 (p = 0.0075). Therefore, the composition of the embodiments of the present invention, containing four strains of lactic acid bacteria, significantly increased serotonin levels compared to the control group containing only a single strain of lactic acid bacteria. In other words, the composition of the embodiments of the present invention has a physiological activity that promotes the increase of serotonin, thereby having a mood-soothing effect on the user. It is understood that an increase in serotonin also helps improve sleep quality; therefore, while improving sleep quality, it can also produce a mood-soothing effect. [(two)] [The effect of taking the composition of one embodiment of the present invention on dopamine:]

[0028] Dopamine is a neurotransmitter that the human body can produce on its own. The nervous system uses dopamine to transmit messages between nerve cells. Dopamine plays a crucial role in making people feel happy, helping them to be motivated, concentrate, and maintain interest in things. When dopamine is insufficient, people may experience fatigue, poor concentration, lack of motivation, and mood swings.

[0029] Blood samples were collected from subjects before and two weeks after administration of the composition described in this invention for dopamine detection. The collected blood was centrifuged to separate serum. The serum was processed using Dopamine ELISA kits (abnova, KA1887) according to the manufacturer's manual. After color development, the absorbance was measured using an ELISA Reader at OD 450 nm, and the dopamine concentration was calculated using a standard curve.

[0030] Figure 3 shows the experimental results of changes in dopamine levels in subjects before and after taking the composition of an embodiment of the present invention. Statistics were calculated using a paired t-test, with p < 0.05 considered statistically significant. As can be seen from Figure 3, after taking the composition of the embodiment of the present invention, most subjects experienced a significant increase in blood dopamine levels, which was statistically significant compared to before taking the composition (p = 0.0001). Therefore, the composition of the embodiment of the present invention has the physiological activity of promoting dopamine production in the human body, thereby having the effect of soothing the user's mood, especially addressing the problem of low mood caused by dopamine deficiency.

[0031] In summary, the compositions of the embodiments of the present invention possess physiological activity that soothes emotions. It should be noted that, compared to compositions containing only a single lactic acid bacteria strain, the compositions of the embodiments of the present invention containing four lactic acid bacteria strains significantly increase serotonin levels, thus demonstrating that the combination of lactic acid bacteria strains in the embodiments of the present invention has unexpected efficacy.

[0032] The embodiments described above are merely for illustrating the technical ideas and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly. They should not be used to limit the patent scope of the present invention. That is, all equivalent changes or modifications made in accordance with the spirit disclosed in the present invention should still be covered within the patent scope of the present invention.

[0033] none

[0034] 1. Taiwan, Republic of China, Food Industry Development Institute, 2024 / 12 / 10, BCRC 911254 2. Taiwan, Republic of China, Food Industry Development Institute, 2024 / 12 / 10, BCRC 911251 3. Taiwan, Republic of China, Food Industry Development Institute Foundation, 2023 / 02 / 20, BCRC 911172 4. Taiwan, Republic of China, Food Industry Development Institute, 2024 / 12 / 10, BCRC 911253

Claims

1. A composition for soothing emotions, comprising: a strain of lactic acid bacteria having a soothing effect, the lactic acid bacteria strain comprising: isolated *Bifidobacterium breve* BBr-28 strain, accession number BCRC 911254; *Bifidobacterium animalis subsp. lactis* PS23 strain, accession number BCRC 911251; *Bifidobacterium longum subsp. infantis* BR631 strain, accession number BCRC 911172; and *Lactobacillus paracasei* BR176 strain, accession number BCRC 911253, the above strains are all stored at the Food Industry Development Institute; and the carrier contains oligosaccharides, sugar alcohols, sodium carboxymethyl cellulose, ethyl cellulose, galactooligosaccharides, stearic acid, magnesium stearate, potato starch or a combination thereof.

2. The composition for soothing emotions as described in claim 1, wherein the effective viable count of the lactic acid bacteria strain is equal to or greater than 5 × 10⁹ CFU / g.

3. The composition for soothing emotions as described in claim 1, wherein the carrier is a physiologically acceptable excipient or diluent.

4. The composition for soothing emotions as described in claim 1, wherein the carrier is a pharmaceutically acceptable excipient or diluent.

5. The composition for relieving mood as described in claim 1, wherein the dosage form is a tablet, capsule or powder.

6. Use of a lactic acid bacteria strain in the preparation of a composition for soothing mood, wherein the composition comprises: a lactic acid bacteria strain having a soothing effect, the lactic acid bacteria strain comprising isolated *Bifidobacterium breve* strain BBr-28, accession number BCRC 911254; *Bifidobacterium animalis subsp. lactis* strain PS23, accession number BCRC 911251; *Bifidobacterium longum subsp. infantis* strain BR631, accession number BCRC 911172; and *Lacticaseibacillus paracasei* strain BR176, accession number BCRC 911253, all of which are registered at the Food Industry Development Institute; and a carrier.

7. The use as described in claim 6, wherein the effective viable count of the lactic acid bacteria strain is equal to or greater than 5 × 10⁹ CFU / g.

8. The use as described in claim 6, wherein the carrier is a physiologically acceptable excipient or diluent.

9. The use as described in claim 6, wherein the carrier is a pharmaceutically acceptable excipient or diluent.

10. The dosage form is tablets, capsules or powder as described in claim 6.

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