Powdered Fermented Fruits for Glycemia Reduction (P2F-GR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Abdominal; Cardiometabolic Risk Factors
• Intervention / Treatment: Other: Fermented orange flour; Other: Fermented grape flour; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie FEUGIER-FAVIER, MD; Phone Number: +33 4 78 86 19 72; Email: nathalie.feugier@chu-lyon.fr
• Study Contact Backup: Name: Julie-Anne NAZARE, PhD; Phone Number: +33 4 78 86 23 22; Email: julie-anne.nazare@univ-lyon1.fr

Study Locations

• France
  • Pierre-Bénite, France
    • Recruiting
    • Centre de Recherche en Nutrition Humaine Rhône-Alpes
    • Contact: Nathalie FEUGIER-FAVIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fermented orange flour; Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates	Other: 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	Other: 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	Other: Control; Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).	Through study completion, an average of 18 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).	Through study completion, an average of 18 days
Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)	Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).	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 digestive hormones (GLP-1 and ghrelin)	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).	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)	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).	Through study completion, 24 hours following the last day
Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis	Indirect calorimetry measurement during the postprandial period (0-240 min) (when taking the standardized breakfast).	Through study completion, an average of 18 days
Satiety and digestive tolerance	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).	Through study completion, 24 hours following the last day
Baseline characteristics	Anthropometric parameters; height (cm),; waist and hip circumference (cm),	Day 0 (at fasting before the standardized breakfast intake)
Dietary intake	Dietary records completed (the day before and the day of the standardized breakfast intake).	Through study completion, an average of 18 days
Baseline characteristics	Anthropometric parameters: - weight (kg)	Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics	Anthropometric parameters: - body composition (lean body mass and fat mass by impedance)	Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics	Metabolic parameters (glycaemia, insulinemia).	Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics	Digestive hormones (GLP-1, ghrelin)	Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics	Expired gases (H2, CH4)	Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics	Resting metabolic rate.	Day 0 (at fasting before the standardized breakfast intake)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Nathalie FEUGIER-FAVIER, MD, Centre de Recherche en Nutrition Humaine Rhône-Alpes

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cardiometabolic risk; Dietary fibers; Postprandial glycaemia; Fermented fruit flour
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Obesity; Obesity, Abdominal
• Other Study ID Numbers: 69HCL20_1032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No