Clinical trial NCT02323542: Plasma Glucose Kinetics and Cereal Product Content in Slowly Digestible Starch (SDS) in Healthy Volunteers
Official title: Plasma Glucose Kinetics Following Ingestion of Two Cereal Products With a Different Content in Slowly Digestible Starch (SDS) in Healthy Males and Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose Kinetics
Keywords: Starch
cereal products
glucose kinetics
blood glucose
blood insulin
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Institut de Recherches Cliniques de Montreal
name: Centre de Recherche en Nutrition Humaine Rhone-Alpe
name: BioFortis
name: MedQualis
First posted: 2014-12-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of appearance of exogenous glucose (RaE)
timeFrame: T0 to 300 minutes
Secondary outcomes:
measure: iAUC RaE
timeFrame: T0 to 300 minutes
measure: 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)
timeFrame: T0 to 300 minutes
measure: iAUC of RdE, RaT, RdT and EGP
timeFrame: T0 to 300 minutes
measure: kinetics of glycemia and insulinemia
timeFrame: T-120 to 300 minutes
measure: iAUC of glycemia and insulinemia
timeFrame: T0 to 300 minutes
measure: Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration
timeFrame: T0 to 300 minutes
measure: iAUC of GIP
timeFrame: T0 to 300 minutes
measure: Kinetics of plasma FFA concentration
timeFrame: T0 to 300 minutes
measure: dAUC of FFA
timeFrame: T0 to 300 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de Recherches Cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de Recherches Cliniques de Montreal
name: Remi Rabasa-Llhoret, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: