Cardiometabolic Risk Factors, Obesity, Abdominal
Conditions
Keywords
Postprandial glycaemia, Dietary fibers, Cardiometabolic risk, Fermented fruit flour
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.
Interventions
OTHERFermented orange flour
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
OTHERFermented grape flour
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
OTHERControl
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through study completion, an average of 18 days | Glycaemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemia tArea Under Curve/insulinemia tArea Under Curve ratio (0-120 and 0-240 min) | Through study completion, an average of 18 days | Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast). |
| 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) | Through study completion, an average of 18 days | 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). |
| Maximum value, total and incremental area under curve (iArea Under Curve and tArea Under Curve 0-240 min) of expired gases (H2, CH4) | Through study completion, 24 hours following the last day | 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). |
| 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 | Through study completion, an average of 18 days | Glycaemia and insulinemia will be measured at time t-30, 0, 15, 30, 45, 60, 90, 120, 180, 240 (when taking the standardized breakfast). |
| Satiety and digestive tolerance | Through study completion, 24 hours following the last day | 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). |
| Baseline characteristics | Day 0 (at fasting before the standardized breakfast intake) | Anthropometric parameters * height (cm), * waist and hip circumference (cm), |
| Dietary intake | Through study completion, an average of 18 days | Dietary records completed (the day before and the day of the standardized breakfast intake). |
| Oxidation of energy substrates (carbohydrates, lipids, proteins) and induced-food thermogenesis | Through study completion, an average of 18 days | Indirect calorimetry measurement during the postprandial period (0-240 min) (when taking the standardized breakfast). |
Countries
France
Contacts
Primary ContactNathalie FEUGIER-FAVIER, MD
Backup ContactJulie-Anne NAZARE, PhD
Outcome results
None listed