Powdered Fermented Fruits for Glycemia Reduction

Hospices Civils de Lyon20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Cardiometabolic Risk Factors Obesity, Abdominal

Interventions

Fermented orange flourOTHER

Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates

Fermented grape flourOTHER

Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates

ControlOTHER

Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, France

RECRUITING

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.

Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast).

Time frame: Through study completion, an average of 18 days

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 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Central Contacts

Nathalie FEUGIER-FAVIER, MD

CONTACT

4 78 86 19 72 nathalie.feugier@chu-lyon.fr

Julie-Anne NAZARE, PhD

CONTACT

4 78 86 23 22 julie-anne.nazare@univ-lyon1.fr

Data from ClinicalTrials.gov

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