Powdered Fermented Fruits for Glycemia Reduction

Overview

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.

Full Title of Study: “Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2022

Interventions

  • Other: Fermented orange flour
    • Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
  • Other: Fermented grape flour
    • Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
  • Other: Control
    • Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

Arms, Groups and Cohorts

  • Experimental: Fermented orange flour
    • Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
  • Experimental: Fermented grape flour
    • Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
  • Placebo Comparator: Control
    • Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
    • Time Frame: Through study completion, an average of 18 days
    • Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
  • Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)
    • Time Frame: Through study completion, an average of 18 days
    • Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).
  • 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)
    • Time Frame: Through study completion, an average of 18 days
    • GLP-1 and ghrelin concentrations will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 and t0, 60, 120, 180, 240 respectively (when taking the standardized breakfast).
  • Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)
    • Time Frame: Through study completion, 24 hours following the last day
    • Expired gases concentrations will be measured at time t-30, 0, 60, 120, 180, 240, 360, 480, before the diner and the breakfast next day (24 hours following the standardized breakfast intake).
  • Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis
    • Time Frame: Through study completion, an average of 18 days
    • Indirect calorimetry measurement during the postprandial period (0-240 min) (when taking the standardized breakfast).
  • Satiety and digestive tolerance
    • Time Frame: Through study completion, 24 hours following the last day
    • Visual analogue scales (VAS) on gastrointestinal symptoms and questionnaires on the consistency and frequency of stools completed, when taking the standardized breakfast (24 hours following the standardized breakfast intake).
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Anthropometric parameters height (cm), waist and hip circumference (cm),
  • Dietary intake
    • Time Frame: Through study completion, an average of 18 days
    • Dietary records completed (the day before and the day of the standardized breakfast intake).
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Anthropometric parameters: – weight (kg)
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Anthropometric parameters: – body composition (lean body mass and fat mass by impedance)
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Metabolic parameters (glycaemia, insulinemia).
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Digestive hormones (GLP-1, ghrelin)
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Expired gases (H2, CH4)
  • Baseline characteristics
    • Time Frame: Day 0 (at fasting before the standardized breakfast intake)
    • Resting metabolic rate.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nathalie FEUGIER-FAVIER, MD, Principal Investigator, Centre de Recherche en Nutrition Humaine Rhône-Alpes
  • Overall Contact(s)
    • Nathalie FEUGIER-FAVIER, MD, 4 78 86 19 72, nathalie.feugier@chu-lyon.fr

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