Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiometabolic Risk Factors
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to evaluate the effects of an acute intake of two fermented fruits flours as part of a standardized breakfast, in comparison with the acute intake of a standardized breakfast without fermented fruits flour but with the same amount of available carbohydrates, on postprandial glycaemic response and overall metabolism in subjects at cardiometabolic risk.
The metabolic parameters will be assessed in fasting and in postprandial period after the consumption of the standardized breakfast.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index between 25 and 35 kg/m2 inclusive
- •Waist circumference \> 80 cm for women and \> 96 cm for men
- •Fibers intake ≤ 25g/day
Exclusion Criteria
- •History of digestive surgery or diseases
- •Current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
- •Current probiotics, prebiotics, fibers complement, and/or any products modulating glucose and lipid metabolism
- •Volunteer with a dietary restriction (vegetarian or high-protein diet for example)
- •Current weight loss diet
- •Pregnant or lactating woman or woman who do not use effective contraception
- •Drinking more than 3 glasses of alcohol per day (\>30g/day)
- •Smoking volunteer
Outcomes
Primary Outcomes
Incremental area under curve (iAUC 0-240 min) of postprandial glycaemia in response to an acute intake of different standardized breakfast including or not a fermented fruits flour but which all contain similar amount of available carbohydrate.
Time Frame: Through study completion, an average of 18 days
Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
Secondary Outcomes
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of digestive hormones (GLP-1 and ghrelin)(Through study completion, an average of 18 days)
- Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis(Through study completion, an average of 18 days)
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-120, 0-240 and 120-240 min) of glycaemia and insulinemia(Through study completion, an average of 18 days)
- Satiety and digestive tolerance(Through study completion, 24 hours following the last day)
- Baseline characteristics(Day 0 (at fasting before the standardized breakfast intake))
- Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)(Through study completion, an average of 18 days)
- Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)(Through study completion, 24 hours following the last day)
- Dietary intake(Through study completion, an average of 18 days)