The Influence of Probiotics on Body Weight and Composition

This is a randomized, double-blinded, placebo-controlled study. After obtaining informed
consent, healthy overweight adults aged 18 to 75 years (n=76/intervention group with n=228
total/study) will be randomized to one of three groups: Lactobacillus, a blend of
Bifidobacterium and Lactobacillus, or placebo. Participants will consume 1 capsule per day
of probiotic or placebo for 12 weeks. Participants will attend weekly behavioral lifestyle
intervention meetings, which will address dietary and physical activity contributions to
weight loss, in groups of approximately 20 subjects during the 12 intervention weeks.

Participants will complete daily questionnaires throughout the week before and during the
intervention period which address subject compliance and bowel habits. A dual X-ray
absorptivity scan will be done to measure body composition during the week before the
intervention and during the 12th week of the intervention period (± 1 week). Blood samples
will be collected via a finger prick at the baseline and final time points. Blood samples
will be used to measure cardiovascular and metabolic markers of health. Stool samples will
be collected from 25 subjects per intervention group during the week before the intervention
period and the 12th week of the intervention period. Dietary intake will be assessed during
the week before the intervention period and during the week of the final appointment (± 1
week). Gastrointestinal symptoms and physical activity questionnaires will be completed upon
providing consent to the study, being randomized to an intervention, and during the last
week of the intervention period. Questionnaires regarding income, weight control strategies,
and quality of life will be completed during randomization and during the last week of the
intervention period. Stool samples will be collected from a subgroup of participants during
the week before the intervention period and during the 12th week of the intervention period.
These samples will be used to detect the presence and/or abundance and/or survival of the
probiotic microorganisms at the end of the digestive tract.

Inclusion Criteria:

To participate in the study you must:

- Be age 18 to 75 years

- Have a BMI ≥ 25

- Be willing to receive random assignment to probiotic or placebo supplementation

- Be willing to and able to complete the Informed Consent Form in English

- Be willing to complete questionnaires, records, and diaries associated with the study
and to complete all study visits

- Be committed to losing weight over the 12-week study period

- 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:

- Have used another investigational product within 3 months of enrolling in the study

- Be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months

- Be allergic to milk, soy, or yeast

- Have gained or lost at least 10 lbs in the previous 3 months

- Have had uncontrolled angina (severe chest pain) within the past 6 months

- Have insulin-dependent diabetes (oral medications are not exclusionary)

- Use weight-loss medications

- Have had cancer treatment (radiation, chemotherapy, or surgery) within the past 6
months or any other treatment or condition known to weaken the immune system (e.g.,
systemic corticosteroids or HIV/AIDS)

- Be currently being treated for or have any of the following physician-diagnosed
diseases or conditions: inflammatory bowel disease, celiac disease, short bowel
syndrome, or any other malabsorptive syndrome?

- Have any physical condition deemed likely to significantly interfere with your
ability to participate in a lifestyle intervention involving eating and physical
activity changes

- Be currently participating in Weight Watcher's or another weight loss program