Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
- Conditions
- Glucose Metabolism DisordersMetabolic SyndromeEndotoxemiaInsulin Resistance
- Interventions
- Dietary Supplement: CranberryDietary Supplement: PlaceboDietary Supplement: Agaves
- Registration Number
- NCT03800277
- Lead Sponsor
- Laval University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cranberry and placebo Placebo Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) Cranberry and placebo Cranberry Cranberry extract (2 capsules) + Placebo powder (1 single-dose packet) Placebo and placebo Placebo Placebo (2 capsules) + Placebo powder (1 single-dose packet) Cranberry and Agaves Agaves Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) Placebo and Agaves Agaves Placebo (2 capsules) + Agaves powder (1 single-dose packet) Cranberry and Agaves Cranberry Cranberry extract (2 capsules) + Agaves powder (1 single-dose packet) Placebo and Agaves Placebo Placebo (2 capsules) + Agaves powder (1 single-dose packet)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 glucose serum concentration At the beginning and the end of treatment (10 weeks) effect of the supplements on serum concentration of glucose
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
Trial Locations
- Locations (1)
Institute of nutrition and functional foods, Laval University
🇨🇦Québec, Quebec, Canada