Powdered Fermented Fruits for Glycemia Reduction

NCT ID: NCT04877548

Last Updated: 2021-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2022-08-01

Brief Summary

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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

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Conditions

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Cardiometabolic Risk Factors Obesity, Abdominal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fermented orange flour

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

Group Type EXPERIMENTAL

Fermented orange flour

Intervention Type OTHER

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

Fermented grape flour

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

Group Type EXPERIMENTAL

Fermented grape flour

Intervention Type OTHER

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

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Fermented orange flour

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

Intervention Type OTHER

Fermented grape flour

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

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie FEUGIER-FAVIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Locations

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Centre de Recherche en Nutrition Humaine Rhône-Alpes

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nathalie FEUGIER-FAVIER, MD

Role: CONTACT

4 78 86 19 72 ext. +33

Julie-Anne NAZARE, PhD

Role: CONTACT

4 78 86 23 22 ext. +33

Facility Contacts

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Nathalie FEUGIER-FAVIER, MD

Role: primary

Other Identifiers

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69HCL20_1032

Identifier Type: -

Identifier Source: org_study_id

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