Clinical Trials Logo

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)
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A