Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers
- Conditions
- Blood Glucose Kinetics
- Interventions
- Other: Nutrition intervention with cereal products
- Registration Number
- NCT02323542
- Lead Sponsor
- Mondelēz International, Inc.
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low-SDS cereal product Nutrition intervention with cereal products Cereal product with low Slowly Digestible Starch content High-SDS biscuit Nutrition intervention with cereal products Biscuit with high Slowly Digestible Starch content
- Primary Outcome Measures
Name Time Method Rate of appearance of exogenous glucose (RaE) T0 to 300 minutes Postprandial kinetic of RaE
- Secondary Outcome Measures
Name Time Method iAUC of glycemia and insulinemia T0 to 300 minutes iAUC of glycemia and insulinemia over selected intervals over the 300-minute postprandial period
Kinetics of plasma FFA concentration T0 to 300 minutes Postprandial kinetic of FFA
iAUC RaE T0 to 300 minutes iAUC of RaE over selected intervals over the 300-minute postprandial period
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) T0 to 300 minutes Postprandial kinetics of RdE, RaT, RdT and EGP
iAUC of RdE, RaT, RdT and EGP T0 to 300 minutes iAUC of RdE, RaT and RdT and dAUC of EGP over selected intervals over the 300-minute postprandial period
kinetics of glycemia and insulinemia T-120 to 300 minutes Pre- and postprandial kinetics of glycemia and insulinemia
Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration T0 to 300 minutes Postprandial kinetic of GIP
iAUC of GIP T0 to 300 minutes iAUC of GIP over selected intervals over the 300-minute postprandial period
dAUC of FFA T0 to 300 minutes dAUC of FFA over selected intervals over the 300-minute postprandial period
Trial Locations
- Locations (1)
Institut de Recherches Cliniques de Montréal
🇨🇦Montréal, Quebec, Canada