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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | 1 capsule per day containing probiotics |
|
| Placebo | Placebo Comparator | 1 capsule per day without probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | 60 days | |
| Body fat percentage | 60 days | |
| Waist circumference |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rotimi Aluko, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richardson Centre for Functional Foods and Nutraceuticals | Winnipeg | Manitoba | R3T 2N2 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| 60 days |
| Hip circumference | 60 days |
| Total fat mass | 60 days |
| Total lean mass | 60 days |
| Gut microbiome | Stool samples will be collected from participants to analyze intestinal microbiota community composition | 60 days |
| Blood pressure | 60 days |
| Blood total cholesterol | 60 days |
| Blood low-density lipoprotein cholesterol | 60 days |
| Blood high-density lipoprotein cholesterol | 60 days |
| Blood triglycerides | 60 days |
| Blood glucose | 60 days |
| Blood insulin | 60 days |
| Aspartate aminotransferase | 60 days |
| Alanine transaminase | 60 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |