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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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The purpose of this research study is to determine whether a probiotic can change the way bile is used by the body. The investigators will also look at the effect of the probiotic on your intestinal health.
This is a randomized, double-blind, placebo controlled crossover study. After obtaining informed consent, healthy, middle-aged adults with a larger waist circumference (n=30/probiotic cross with n=90 total/study) will be randomized to one of four groups: Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis subsp. lactis, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 6 weeks. After a 4-week washout period, participants will be crossed to the other treatment (i.e., probiotic to placebo or placebo to probiotic).
Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected at the baseline and final time points (±3 days) of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms and physical activity questionnaires will be completed weekly during each intervention period and also the weeks before and after each intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design). |
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| Probiotic: Bacillus subtilis | Experimental | Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Probiotic: Lactobacillus plantarum | Experimental | Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Probiotic: Bifidobacterium animalis | Experimental | Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic: Bacillus subtilis | Dietary Supplement | Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in deconjugated bile acids in the blood | Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group. | Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety and glucose metabolism | Levels of hormones associated with hunger, satiety and glucose metabolism in the blood will be compared between treatment periods for each subject/group. Daily questionnaires will also assess hunger/satiety. | Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory status | Levels of inflammatory markers in the blood will be compared between treatment periods for each subject/group. | Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 |
Inclusion Criteria
To participate in the study you must:
Exclusion Criteria:
To participate in the study you must NOT:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31090458 | Derived | Culpepper T, Rowe CC, Rusch CT, Burns AM, Federico AP, Girard SA, Tompkins TA, Nieves C Jr, Dennis-Wall JC, Christman MC, Langkamp-Henken B. Three probiotic strains exert different effects on plasma bile acid profiles in healthy obese adults: randomised, double-blind placebo-controlled crossover study. Benef Microbes. 2019 May 28;10(5):497-509. doi: 10.3920/BM2018.0151. Epub 2019 May 15. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586340 | bificin C6165, Bifidobacterium animalis |
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| Lactobacillus plantarum | Dietary Supplement | Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Bifidobacterium animalis | Dietary Supplement | Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
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| Placebo | Dietary Supplement | Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design). |
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