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

NCT ID: NCT01879098

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).

Probiotic: Bacillus subtilis

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).

Group Type: EXPERIMENTAL

Probiotic: Bacillus subtilis

Intervention Type: 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).

Probiotic: 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).

Group Type: EXPERIMENTAL

Lactobacillus plantarum

Intervention Type: 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).

Probiotic: 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).

Group Type: EXPERIMENTAL

Bifidobacterium animalis

Intervention Type: 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).

Interventions

Probiotic: Bacillus subtilis

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Bacillus subtilis R0179; Lactobacillus plantarum HA-119; Bifidobacterium animalis subsp. lactis LAFTI B94

Eligibility Criteria

Inclusion Criteria

To participate in the study you must:

• Be 35-65 years of age.
• Have a waist circumference > 102 cm (40 in) for males, and > 88 cm (35 in) for females.
• Be willing and able to complete the Informed Consent Form in English.
• Be available for 18 consecutive weeks to participate in this study.
• Be willing and able to complete daily and weekly questionnaires regarding general wellness, bowel function, gastrointestinal symptoms, physical activity level, and dietary intake.
• Be willing to provide 4 blood samples and 4 stool samples.
• Be willing to maintain your regular level of physical activity and your diet for 18-week study.
• Be able to take the study supplement without the aid of another person.
• Be willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
• Be willing to provide a social security number (SS#) to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbi Langkamp-Henken, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31090458 (View on PubMed)

Other Identifiers

IRB# 70-2013

Identifier Type: -

Identifier Source: org_study_id