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

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.

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.