Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers

Study Overview
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Brief Summary
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The present study aims at investigating the effect of ingesting 2 cereal products differing by their SDS content on the kinetics of glucose in healthy volunteers.

Detailed Description
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The present study will compare the effect of consuming cereal products alone on : the rates of appearance and disappearance of exogenous and total glucose the glycemic and insulinemic responses the postprandial GIP concentrations

Official Title
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Plasma Glucose Kinetics Following Ingestion of Two Cereal Products With a Different Content in Slowly Digestible Starch (SDS) in Healthy Males and Females

Conditions
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Blood Glucose Kinetics

Intervention / Treatment
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* Other: Nutrition intervention with cereal products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteer, male or female (half male, half female); Aged between 18 and 40 years old (bounds included); Non-smoker; BMI ranging between 18.5 and 25 kg/m2 (bounds included) Waist circumference ≤ 94 cm for men and ≤ 80 cm for women; Stable body weight (± 1 kg) over the 3 months preceding the experimental period; Systolic blood pressure between 95 and 145 mmHg and diastolic blood pressure between 50 and 85 mmHg; For the female subjects: use of an oral contraceptive with regular menstrual cycles; Subject not displaying any identified significant metabolic impairment according to the Principal Investigator; Sedentary or with a moderate physical activity; Not having given blood in the month prior to the selection and accepting not to give blood during the experimental period of the present study; Regularly consuming a breakfast providing more than 15% of the total daily energy intake, including at least one cereal product; adequate partitioning of macronutrient intake; Providing written consent for his/her participation to the study; Exclusion Criteria: Subject with a severe or acute disease which should influence the results of the study and to be life-threatening for the volunteer according to the Principal Investigator; Subject with medical history of symptomatic vascular diseases (infarct, angina pectoris, syndrome of threat, surgery or endovascular surgery, stroke, symptomatic peripheral arteritis) which according to the investigator should interfere with the results from the study or should constitute a particular risk for the subject; Subject with type 1 or type 2 diabetes; Subject with any food allergy; Subject with eating disorders (e.g. anorexia nervosa & bulimia) according to the Principal Investigator; Subject regularly consuming more than 20 g/day of alcohol; Subject regularly consuming recreational drugs; Subject consuming regularly corticoids, anorectics, adrenergic drugs, gastric demulcent, cholesterol and/or lipid lowering medication, weight-loss drugs or other drugs or supplement that should impact glucose metabolism in the Principal Investigator's opinion; Pregnant or lactating women; Currently participating in another study or having participated in another study in the 3 months prior to the selection visit; Consuming large amounts of food products naturally rich in 13C.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: High-SDS biscuit<br>Biscuit with high Slowly Digestible Starch content | Other: Nutrition intervention with cereal products<br>* acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content<br>|
| Active Comparator: Low-SDS cereal product<br>Cereal product with low Slowly Digestible Starch content | Other: Nutrition intervention with cereal products<br>* acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of appearance of exogenous glucose (RaE) | Postprandial kinetic of RaE | T0 to 300 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iAUC RaE | iAUC of RaE over selected intervals over the 300-minute postprandial period | T0 to 300 minutes | 
| kinetics of Rate of disappearance of exogenous glucose (RdE), Rate of appearance of total glucose (RaT), Rate of disappearance of total glucose (RdT) and Endogenous glucose production (EGP) | Postprandial kinetics of RdE, RaT, RdT and EGP | T0 to 300 minutes | 
| iAUC of RdE, RaT, RdT and EGP | iAUC of RdE, RaT and RdT and dAUC of EGP over selected intervals over the 300-minute postprandial period | T0 to 300 minutes | 
| kinetics of glycemia and insulinemia | Pre- and postprandial kinetics of glycemia and insulinemia | T-120 to 300 minutes | 
| iAUC of glycemia and insulinemia | iAUC of glycemia and insulinemia over selected intervals over the 300-minute postprandial period | T0 to 300 minutes | 
| Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration | Postprandial kinetic of GIP | T0 to 300 minutes | 
| iAUC of GIP | iAUC of GIP over selected intervals over the 300-minute postprandial period | T0 to 300 minutes | 
| Kinetics of plasma FFA concentration | Postprandial kinetic of FFA | T0 to 300 minutes | 
| dAUC of FFA | dAUC of FFA over selected intervals over the 300-minute postprandial period | T0 to 300 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Starch, cereal products, glucose kinetics, blood glucose, blood insulin