Powdered Fermented Fruits for Glycemia Reduction

Not Applicable

• Conditions: Cardiometabolic Risk Factors; Obesity, Abdominal
• Interventions: Other: Control; Other: Fermented orange flour; Other: Fermented grape flour

• Registration Number: NCT04877548
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-07
• Status Verified: 2021-09
• Study Start: 2021-09-07
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	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).
Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis	Through study completion, an average of 18 days	Indirect calorimetry measurement during the postprandial period (0-240 min) (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 glycaemia and insulinemia	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).
Satiety and digestive tolerance	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	Day 0 (at fasting before the standardized breakfast intake)	Resting metabolic rate.
Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)	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 0-240 min) of expired gases (H2, CH4)	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).
Dietary intake	Through study completion, an average of 18 days	Dietary records completed (the day before and the day of the standardized breakfast intake).

Trial Locations

Locations (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes; 🇫🇷 Pierre-Bénite, France