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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endotoxemia
- Sponsor
- Laval University
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Helene Jacques
Professor
Laval University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
Time Frame: At the beginning and the end of treatment (10 weeks)
effect of the supplements on variation in plasma concentration of LPS and LBP
Secondary Outcomes
- Change in intestinal permeability: Measure concentration of zonulin in plasma(At the beginning and the end of treatment (10 weeks))
- 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))
- 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))
- Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum(At the beginning and the end of treatment (10 weeks))
- Change in glucose serum concentration(At the beginning and the end of treatment (10 weeks))
- Change in insulin and C-peptide serum concentration(At the beginning and the end of treatment (10 weeks))