Endotoxemia, Metabolic Syndrome, Glucose Metabolism Disorders, Insulin Resistance
Conditions
Brief summary
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.
Detailed description
It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut. The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
Interventions
DIETARY_SUPPLEMENTCranberry
Supplementation of polyphenols from cranberry extract
DIETARY_SUPPLEMENTAgaves
Supplementation of inulin from Agaves powder
DIETARY_SUPPLEMENTPlacebo
Supplementation with placebo
Sponsors
Ministry of Agriculture, Fisheries and Food, Quebec
Ministry of economic development, innovation and export trade, Quebec
Diana Food, Symrise
Atrium Innovations
NutriAgaves, Mexico
Société des Produits Nestlé (SPN)
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma | At the beginning and the end of treatment (10 weeks) | effect of the supplements on variation in plasma concentration of LPS and LBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces | At the beginning and the end of treatment (10 weeks) | effect of the supplements on fecal calprotectin and lactoferrin |
| Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum | At the beginning and the end of treatment (10 weeks) | effect of the supplements on chronic inflammation (serum concentration of hsCRP, Il-6, TNF-alpha, IL-1 beta, IL-23) |
| Change in intestinal permeability: Measure concentration of zonulin in plasma | At the beginning and the end of treatment (10 weeks) | effect of the supplements on plasma concentration of zonulin |
| Change in insulin and C-peptide serum concentration | At the beginning and the end of treatment (10 weeks) | effect of the supplements on serum concentration of insulin and C-peptide |
| Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.) | At the beginning and the end of treatment (10 weeks) | Global variation of the fecal microbiota and gut microbiota profiling |
| Change in glucose serum concentration | At the beginning and the end of treatment (10 weeks) | effect of the supplements on serum concentration of glucose |
Countries
Canada
Outcome results
None listed