An interventional study of Fermented orange flour and Fermented grape flour in Cardiometabolic Risk Factors and Obesity, Abdominal, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science
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.
274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Exclusion Criteria:
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
Other: Fermented orange flour
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
Other: Fermented grape flour
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
Other: Control
Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
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).
Time frame: 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 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Through study completion, 24 hours following the last day
Baseline characteristics
Anthropometric parameters * height (cm), * waist and hip circumference (cm),
Time frame: 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).
Time frame: Through study completion, an average of 18 days
Baseline characteristics
Anthropometric parameters: - weight (kg)
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Anthropometric parameters: - body composition (lean body mass and fat mass by impedance)
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Metabolic parameters (glycaemia, insulinemia).
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Digestive hormones (GLP-1, ghrelin)
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Expired gases (H2, CH4)
Time frame: Day 0 (at fasting before the standardized breakfast intake)
Baseline characteristics
Resting metabolic rate.
Time frame: Day 0 (at fasting before the standardized breakfast intake)
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon