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| Name | Class |
|---|---|
| Dairy Management Inc. | INDUSTRY |
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In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.
Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act independently of the matrix used to deliver them to the human host. This thinking ignores the impact the delivery matrix (food or dietary supplement) may have on both the physiology of the probiotic organism and on the human host and is likely not true.
Historically the most common "probiotic foods" have been fermented dairy products, particularly yogurts. Since yogurts are commonly understood to contain live "good" bacteria they are well accepted by consumers. However, increasingly over the last decade, probiotics are being added to non-dairy-based foods (juice, chocolate, cookies, etc) or consumed as supplements (tablets/capsules). While this expands the options for people to obtain probiotic organism, it is not clear whether probiotics delivered in these products are as efficacious as when delivered in a dairy food. In fact, the buffering capacity and nutrient composition of milk products may directly influence efficacy of the probiotic by increasing survival during passage through the gastrointestinal tract (GIT) and by modifying the physiology of the probiotic organism. In addition, fermentation products produced by the probiotic during manufacture of yogurt may also have an influence on the efficacy of probiotic bacteria.
Our hypotheses are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yogurt smoothie without probiotic. | Placebo Comparator |
| |
| Probiotic added post fermentation. | Experimental |
| |
| Probiotic added pre-fermentation. | Experimental |
| |
| A capsule containing the probiotic. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt smoothie without probiotic | Dietary Supplement | A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal transit time | Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule. | Weeks 4, 10, 16, 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period | Weeks 4, 10, 16, 22 and 28 | |
| Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period |
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Inclusion Criteria:
Exclusion Criteria:
Note: If a participant experiences a delay in passing the capsule (beyond five days) they will be treated accordingly and excluded from future participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Penny M Kris-Etherton, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17013448 | Background | Drossman DA, Dumitrascu DL. Rome III: New standard for functional gastrointestinal disorders. J Gastrointestin Liver Dis. 2006 Sep;15(3):237-41. | |
| 34232082 | Derived | Ba Z, Lee Y, Meng H, Kris-Etherton PM, Rogers CJ, Lewis ZT, Mills DA, Furumoto EJ, Rolon ML, Fleming JA, Roberts RF. Matrix Effects on the Delivery Efficacy of Bifidobacterium animalis subsp. lactis BB-12 on Fecal Microbiota, Gut Transit Time, and Short-Chain Fatty Acids in Healthy Young Adults. mSphere. 2021 Aug 25;6(4):e0008421. doi: 10.1128/mSphere.00084-21. Epub 2021 Jul 7. |
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|
| Yogurt smoothie with probiotic added post fermentation | Dietary Supplement | A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). |
|
|
| Yogurt smoothie with probiotic added pre-fermentation | Dietary Supplement | A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). |
|
|
| A capsule containing the probiotic | Dietary Supplement | A capsule taken daily will provide between 10x^y9 and 10x^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12). |
|
|
| Weeks 4, 10, 16, 22, 28 |
| 28662676 | Derived | Lee Y, Ba Z, Roberts RF, Rogers CJ, Fleming JA, Meng H, Furumoto EJ, Kris-Etherton PM. Effects of Bifidobacterium animalis subsp. lactis BB-12(R) on the lipid/lipoprotein profile and short chain fatty acids in healthy young adults: a randomized controlled trial. Nutr J. 2017 Jun 29;16(1):39. doi: 10.1186/s12937-017-0261-6. |
| 26821116 | Derived | Meng H, Lee Y, Ba Z, Peng J, Lin J, Boyer AS, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 impacts upper respiratory tract infection and the function of NK and T cells in healthy adults. Mol Nutr Food Res. 2016 May;60(5):1161-71. doi: 10.1002/mnfr.201500665. Epub 2016 Mar 1. |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D015014 | Yogurt |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D001628 | Beverages |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
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