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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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This study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. Participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. These periods will occur in random order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will consume one yogurt smoothie daily for the duration of the intervention that contains 3.16 × 109 colony forming units (CFU) bifidobacterium animalis subsp. lactis BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods. |
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| Control | Placebo Comparator | Participants will consume one yogurt smoothie daily for the duration of the intervention that contains no BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yogurt smoothie with BB-12 | Drug | During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in inflammatory markers | Change in inflammatory markers in the serum and secreted cytokines from lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells compared to baseline. In the serum the markers to be investigated are high sensitivity c-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-a), interleukin 1 beta (IL-1B), IL-6, IL-8, IL-10, IL-12p70, monocyte chemotactic protein 1 (MCP-1), macrophage inflammatory protein alpha (MIP-1a), sCD14, and LPS binding protein (LPB). From LPS-stimulated peripheral blood mononuclear cells the cytokines to be investigated are TNF-a, IL-1B, IL-6, IL-8, IL-10, IL-12p70, MCP-1, and MIP-1a. Changes in these inflammatory markers will assist in understanding how the consumption of yogurt containing BB-12 affects the inflammatory status of obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in number and activation of leukocytes | Change in quantity and activation of T cells, B cells, dendritic cells, natural killer cells, and monocytes measured by flow cytometry before and after each period. Changes in the number and activation of leukocytes will assist in understanding the impacts of the consumption of yogurt containing BB-12 on leukocytes in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in trimethylamine N-oxide (TMAO) in serum | Change in TMAO in serum measured using liquid chromatography with tandem mass spectrometry (LC-MS) compared to baseline. Changes in TMAO, which is associated with gut microbiota, will assist in understanding the mechanism that connects changes in the commensal microbiota in the gut to inflammatory outcomes in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connie J Rogers, PhD, MPH | Contact | 814 867 3716 | cjr102@psu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26621631 | Background | Meng H, Ba Z, Lee Y, Peng J, Lin J, Fleming JA, Furumoto EJ, Roberts RF, Kris-Etherton PM, Rogers CJ. Consumption of Bifidobacterium animalis subsp. lactis BB-12 in yogurt reduced expression of TLR-2 on peripheral blood-derived monocytes and pro-inflammatory cytokine secretion in young adults. Eur J Nutr. 2017 Mar;56(2):649-661. doi: 10.1007/s00394-015-1109-5. Epub 2015 Nov 30. | |
| 20420526 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 10, 2025 | Feb 28, 2025 | 9 | ||
| Aug 5, 2025 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Yogurt smoothie | Drug | During the one month control period, the participants will consume one yogurt smoothie daily. |
|
| Change in gut permeability | Change in gut permeability, assessed using a lactulose/mannitol gut permeability assay, from baseline. Changes in gut permeability will assist in understanding the impacts of the consumption of yogurt containing BB-12 on gut health and permeability in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Change in gut microbiota populations | Change in gut microbiota populations, assessed with 16s ribosomal ribonucleic acid (rRNA), compared to baseline. Changes in microbial populations will assist in understanding the impacts of the consumption of yogurt containing BB-12 on commensal gut microbiota in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Change in metabolism of gut microbiota populations | Change in the metabolism of gut microbiota populations, measured via transcriptomics, compared to baseline. Changes in the transcriptome of the commensal microbiota will assist in understanding the impacts of the consumption of yogurt containing BB-12 on the metabolism of commensal gut microbiota in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Change in serum metabolomic profile | Change in serum metabolomic profile, assessed in hydrophilic and hydrophobic fractions, compared to baseline. Changes in the metabolomic profile will assist in understanding the underlying mechanisms that connect consumption of yogurt containing BB-12 to changes in inflammatory status in obese individuals. | At baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) |
| Background |
| Aggarwal BB. Targeting inflammation-induced obesity and metabolic diseases by curcumin and other nutraceuticals. Annu Rev Nutr. 2010 Aug 21;30:173-99. doi: 10.1146/annurev.nutr.012809.104755. |
| 22872030 | Background | Leber B, Tripolt NJ, Blattl D, Eder M, Wascher TC, Pieber TR, Stauber R, Sourij H, Oettl K, Stadlbauer V. The influence of probiotic supplementation on gut permeability in patients with metabolic syndrome: an open label, randomized pilot study. Eur J Clin Nutr. 2012 Oct;66(10):1110-5. doi: 10.1038/ejcn.2012.103. Epub 2012 Aug 8. |
| 18305141 | Background | Cani PD, Bibiloni R, Knauf C, Waget A, Neyrinck AM, Delzenne NM, Burcelin R. Changes in gut microbiota control metabolic endotoxemia-induced inflammation in high-fat diet-induced obesity and diabetes in mice. Diabetes. 2008 Jun;57(6):1470-81. doi: 10.2337/db07-1403. Epub 2008 Feb 27. |
| 26315217 | Background | Sugahara H, Odamaki T, Fukuda S, Kato T, Xiao JZ, Abe F, Kikuchi J, Ohno H. Probiotic Bifidobacterium longum alters gut luminal metabolism through modification of the gut microbial community. Sci Rep. 2015 Aug 28;5:13548. doi: 10.1038/srep13548. |
| 21899798 | Background | Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M. Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12(R) and Lactobacillus paracasei ssp. paracasei, L. casei 431(R) in an influenza vaccination model: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2012 Mar;107(6):876-84. doi: 10.1017/S000711451100420X. Epub 2011 Sep 7. |
| Aug 22, 2025 |
| 10 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |