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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800277
Other study ID # GASTRO-Phenulin (2016-317)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2018
Est. completion date December 31, 2021

Study information

Verified date March 2023
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Dietary Supplement:
Cranberry
Supplementation of polyphenols from cranberry extract
Agaves
Supplementation of inulin from Agaves powder
Placebo
Supplementation with placebo

Locations

Country Name City State
Canada Institute of nutrition and functional foods, Laval University Québec Quebec

Sponsors (7)

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)

Country where clinical trial is conducted

Canada, 

Outcome

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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