The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Lactobacillus plantarum; Dietary Supplement: Placebo; Dietary Supplement: Bifidobacterium animalis

• Registration Number: NCT01879098
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-17
• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

To participate in the study you must NOT:

• Fail to meet any of the criteria I mentioned above.
• Consume >20 g fiber daily, according to the Block Fiber Screener.
• Be taking any statins or cholesterol-lowering prescription drugs now, or within the last 6 months.
• Be currently taking any constipation or diarrhea on a regular basis.
• Be currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
• Have used plant sterols, n-3 fatty acids, fish oil, soy protein, soluble oat fiber, psyllium seed husk or other cholesterol-lowering supplements within the last 3 months.
• Have received antibiotic therapy or a colonoscopy in the past two months.
• Currently be treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, colostomy, but not including Gastroesophageal Reflux Disease (GERD); or have a central venous catheter.
• Taking medications for type 1 or type 2 diabetes.
• Be physically active or very physically active. Active = typical daily living activities PLUS at least 60 minutes of daily moderate activity. Very active = typical daily living activities PLUS at least 60 minutes of daily moderate activity, PLUS an additional 60 minutes of vigorous activity OR 120 minutes of moderate activity.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic: Lactobacillus plantarum	Lactobacillus plantarum	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).
Placebo	Placebo	Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Probiotic: Bifidobacterium animalis	Bifidobacterium animalis	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).

Primary Outcome Measures

Name	Time	Method
Difference in deconjugated bile acids in the blood	Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18	Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group.

Secondary Outcome Measures

Name	Time	Method
Satiety and glucose metabolism	Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States