Powdered Fermented Fruits for Glycemia Reduction (P2F-GR)

Civil Hospices of Lyon

Status: Unknown

Conditions: Cardiometabolic Risk Factors; Obesity, Abdominal

Treatments: Other: Control; Other: Fermented grape flour; Other: Fermented orange flour

Study type: Interventional

Funder types: Other

Identifiers

NCT04877548

69HCL20_1032

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups, including a placebo group

Fermented orange flour

Experimental group

Description:

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

Treatment:

Other: Fermented orange flour

Fermented grape flour

Experimental group

Description:

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

Treatment:

Other: Fermented grape flour

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Control