Metabolic Syndrome Clinical Trial
— MICAOfficial title:
Evaluation of the Effect of Cranberry Whole Fruit Powder on Gut Microbiota Diversity, Intestinal Health and Metabolic Syndrome in Overweight Individuals: a Proof-of-concept Study
Verified date | March 2020 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is of major importance to refine prevention strategies in order to alleviate inflammation, insulin resistance and metabolic syndrome and it appear that improving gut health and microbiota represent a promising strategy. Cranberry-enriched diets may help prevent metabolic syndrome and its associated chronic diseases by a protective effect of gut health and microbiota. It is therefore highly relevant to test the hypothesis that a whole cranberry powder supplements (which include a mixture of polyphenols, free and fiber-associated proanthocyanidins, and fruits fibers) is associated with changes on the gut health and microbiota playing a major role in alleviating inflammation and obesity-associated metabolic disorders.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - overweight - fasting insulin > 42 pmol/L - non smoking - Stable weight in the past 3 months Exclusion Criteria: - chronic diseases - Taking drugs that could affect glucose or lipid metabolism - Taking anti-inflammatory, immunosuppressant or anticoagulant drugs - Inflammatory bowel disease - vegetarians, vegan or following any restrictive dietary pattern or if they are big consumers of berries (>1 portion/day) - taking pre- and probiotics - antibiotics in the past 3 months or change in their regular medication - Major surgery in the past 3 months - taste aversion for cranberries or cranberry allergy or allergies to other ingredients used in the placebo |
Country | Name | City | State |
---|---|---|---|
Canada | Institut sur la nutrition et les aliments fonctionnels | Québec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Naturex |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Gut Microbiota Diversity | Global variation of the fecal microbiota | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Endotoxemia | Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Intestinal permeability | Plasma zonulin | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Inflammation state of the tissue | Fecal calprotectin and chromogranin | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Short chain fatty acids in the feces | Measure short chain fatty acids in the feces | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Gut health and stool consistency | Evaluation of gastrointestinal symptoms and stool consistency using standardized questionnaires | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Lipid profile | Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL and Apolipoprotein B from the beginning to the end of two dietary treatment | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in chronic inflammation | Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP) | At the beginning and the end of each treatment (4 weeks each) | |
Secondary | Change in Glucose homeostasis | Evaluation of plasma fasting glucose and insulin concentration | At the beginning and the end of each treatment (4 weeks each) |
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