Powdered Fermented Fruits for Glycemia Reduction

Obesity, Abdominal Clinical Trial

— P2F-GR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877548
• Other study ID #: 69HCL20_1032
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2021
• Source: Hospices Civils de Lyon
• Contact: Nathalie FEUGIER-FAVIER, MD
• Phone: 4 78 86 19 72
• Email: nathalie.feugier[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors
• Obesity, Abdominal

Intervention

Other:
• Fermented orange flour
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
• Control
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Baseline characteristics	Anthropometric parameters; height (cm),; waist and hip circumference (cm),	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Dietary intake	Dietary records completed (the day before and the day of the standardized breakfast intake).	Through study completion, an average of 18 days
Secondary	Baseline characteristics	Anthropometric parameters: - weight (kg)	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Baseline characteristics	Anthropometric parameters: - body composition (lean body mass and fat mass by impedance)	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Baseline characteristics	Metabolic parameters (glycaemia, insulinemia).	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Baseline characteristics	Digestive hormones (GLP-1, ghrelin)	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Baseline characteristics	Expired gases (H2, CH4)	Day 0 (at fasting before the standardized breakfast intake)
Secondary	Baseline characteristics	Resting metabolic rate.	Day 0 (at fasting before the standardized breakfast intake)