Clinical trial NCT02465294: The Influence of Probiotics on Body Weight and Composition
Official title: The Influence of Probiotics With a Behavioral Life Style Intervention on Body Weight and Composition in Overweight Participants: A Randomized, Double-blinded, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Overweight
Keywords: Probiotics
Weight loss
Body composition
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the addition of two different probiotic interventions to a comprehensive behavioral lifestyle intervention on body weight loss and overall health in overweight adults.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in baseline to week 12 in the percentage of body weight lost between the probiotic groups and the placebo group
timeFrame: Change from Baseline (start of week 1) to Week 12
Secondary outcomes:
measure: Changes in body composition (Fat mass) between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline to Week 12
measure: Changes in body composition (Waist circumference) between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline to Week 12
measure: Changes in body composition (Sagittal abdominal diameter) between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline to Week 12
measure: Changes in bowel habits between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline (Week -1) to Week 12
measure: Changes in gastrointestinal symptoms between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline (Week -1) to Week 12
measure: Changes in markers of cardiovascular health between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline to Week 12
measure: Changes in nutritional intake between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline (Week -1) to Week 12
measure: Changes in weight control strategies between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline (Week -1) to Week 12
measure: Changes in intestinal microbiota community composition between the probiotic groups and the placebo group
timeFrame: Changes from Pre-baseline (Week -1) to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD
role: PRINCIPAL_INVESTIGATOR
References: