Metabolic Syndrome Clinical Trial
— PhenulinOfficial title:
Prebiotic Supplementation and Metabolic Endotoxemia and Modulation of the Gut Microbiota: Double-blind and Randomized Parallel Clinical Study of the Efficacy and Synergistical Effect of Cranberry Polyphenols and Inulin From Agaves
Verified date | March 2023 |
Source | Laval University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
Status | Completed |
Enrollment | 122 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - overweight (BMI 25-39.9 kg/m2) or waist circumference = 80 cm (women) and =94 cm (men) - fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L - at least one of the following criteria: Tg = 1.7 mmol/L; blood pressure = 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L - non-smoking - eating fruits and vegetables less then 5 portions/day Exclusion Criteria: - chronic disease - taking drugs or natural health products that could affect glucose or lipid metabolism - taking anti-inflammatory, antiacids - taking pre or probiotics - inflammatory bowel disease - antibiotics in the past 3 months - allergy or intolerance to cranberries or agaves - Major surgery in the past 3 months |
Country | Name | City | State |
---|---|---|---|
Canada | Institute of nutrition and functional foods, Laval University | Québec | Quebec |
Lead Sponsor | Collaborator |
---|---|
Laval University | Atrium Innovations, Diana Food, Symrise, Ministry of Agriculture, Fisheries and Food, Quebec, Ministry of economic development, innovation and export trade, Quebec, NutriAgaves, Mexico, Société des Produits Nestlé (SPN) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma | effect of the supplements on variation in plasma concentration of LPS and LBP | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in intestinal permeability: Measure concentration of zonulin in plasma | effect of the supplements on plasma concentration of zonulin | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces | effect of the supplements on fecal calprotectin and lactoferrin | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum | effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23) | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in glucose serum concentration | effect of the supplements on serum concentration of glucose | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in insulin and C-peptide serum concentration | effect of the supplements on serum concentration of insulin and C-peptide | At the beginning and the end of treatment (10 weeks) | |
Secondary | Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.) | Global variation of the fecal microbiota and gut microbiota profiling | At the beginning and the end of treatment (10 weeks) |
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