Powdered Fermented Fruits for Glycemia Reduction

Study Overview
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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.

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

Conditions
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Cardiometabolic Risk Factors, Obesity, Abdominal

Intervention / Treatment
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* Other: Fermented orange flour
* Other: Fermented grape flour
* Other: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented orange flour<br>Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates | Other: Fermented orange flour<br>* Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates<br>|
| Experimental: Fermented grape flour<br>Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates | Other: Fermented grape flour<br>* Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates<br>|
| Placebo Comparator: Control<br>Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates | Other: Control<br>* Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour