Clinical trial NCT04877548: Powdered Fermented Fruits for Glycemia Reduction
Official title: Randomized Pilot Study to Measure the Effects of an Acute Intake of Fermented Fruits Flours on Postprandial Glycaemic Response and Metabolic Profile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiometabolic Risk Factors
Obesity, Abdominal
Keywords: Postprandial glycaemia
Dietary fibers
Cardiometabolic risk
Fermented fruit flour
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 18 days
Secondary outcomes:
measure: 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
timeFrame: Through study completion, an average of 18 days
measure: Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min)
timeFrame: Through study completion, an average of 18 days
measure: 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)
timeFrame: Through study completion, an average of 18 days
measure: Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4)
timeFrame: Through study completion, 24 hours following the last day
measure: Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis
timeFrame: Through study completion, an average of 18 days
measure: Satiety and digestive tolerance
timeFrame: Through study completion, 24 hours following the last day
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Dietary intake
timeFrame: Through study completion, an average of 18 days
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
measure: Baseline characteristics
timeFrame: Day 0 (at fasting before the standardized breakfast intake)
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study officials:
affiliation: Centre de Recherche en Nutrition Humaine Rhône-Alpes
name: Nathalie FEUGIER-FAVIER, MD
role: PRINCIPAL_INVESTIGATOR
References: