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

About this trial
This is an interventional basic science trial for Healthy focused on measuring probiotics, inflammation, bile, hunger, satiety
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.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Experimental
Experimental
Placebo
Probiotic: Bacillus subtilis
Probiotic: Lactobacillus plantarum
Probiotic: Bifidobacterium animalis
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
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).