The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation
Evaluation of the Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation in Healthy, Middle-aged Adults: a Randomized, Double-blinded, Placebo-controlled Study
1 other identifier
interventional
155
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Aug 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2013
CompletedFirst Posted
Study publicly available on registry
June 17, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 10, 2014
July 1, 2014
10 months
June 12, 2013
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Satiety and glucose metabolism
Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Other Outcomes (1)
Inflammatory status
Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Probiotic: Bacillus subtilis
EXPERIMENTALBacillus 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
EXPERIMENTALLactobacillus 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
EXPERIMENTALBifidobacterium 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
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).
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).
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).
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Lallemand Health Solutionscollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (1)
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.
PMID: 31090458DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bobbi Langkamp-Henken, PhD, RD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2013
First Posted
June 17, 2013
Study Start
August 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
July 10, 2014
Record last verified: 2014-07