Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and cardiovascular disease (CVD).
Detailed Description
Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level. After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Overweight, obese men and women volunteers aged between 18-65 yrs
- •BMI equal to or greater than 25
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- •Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
- •Able to provide informed consent.
- •Women of childbearing potential with a negative pregnancy test at screening.
- •Exclusion Criteria
- •BMI greater than 35
- •Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- •Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Body weight
Time Frame: 60 days
Secondary Outcomes
- Blood total cholesterol(60 days)
- Alanine transaminase(60 days)
- Body fat percentage(60 days)
- Blood insulin(60 days)
- Body mass index(60 days)
- Hip circumference(60 days)
- Gut microbiome(60 days)
- Blood low-density lipoprotein cholesterol(60 days)
- Waist circumference(60 days)
- Total fat mass(60 days)
- Blood pressure(60 days)
- Blood high-density lipoprotein cholesterol(60 days)
- Blood triglycerides(60 days)
- Aspartate aminotransferase(60 days)
- Total lean mass(60 days)
- Blood glucose(60 days)