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

NCT ID: NCT02323542

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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

Conditions

Blood Glucose Kinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

High-SDS biscuit

Biscuit with high Slowly Digestible Starch content

Group Type: EXPERIMENTAL

Nutrition intervention with cereal products

Intervention Type: OTHER

acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content

Low-SDS cereal product

Cereal product with low Slowly Digestible Starch content

Group Type: ACTIVE_COMPARATOR

Nutrition intervention with cereal products

Intervention Type: OTHER

acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content

Interventions

Nutrition intervention with cereal products

acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: collaborator

Centre de Recherche en Nutrition Humaine Rhone-Alpe

OTHER

Sponsor Role: collaborator

BioFortis

OTHER

Sponsor Role: collaborator

MedQualis

INDUSTRY

Sponsor Role: collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Remi Rabasa-Llhoret, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut de Recherches Cliniques de Montreal

Locations

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

KBE032

Identifier Type: -

Identifier Source: org_study_id