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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Glucose Kinetics
• Intervention / Treatment: Other: Nutrition intervention with cereal products

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2W1R7
      • Institut de Recherches Cliniques de Montreal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-SDS biscuit; Biscuit with high Slowly Digestible Starch content	Other: Nutrition intervention with cereal products; acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content
Active Comparator: Low-SDS cereal product; Cereal product with low Slowly Digestible Starch content	Other: Nutrition intervention with cereal products; acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe; Institut de Recherches Cliniques de Montreal; BioFortis; MedQualis
• Investigators: Principal Investigator: Remi Rabasa-Llhoret, MD, PhD, Institut de Recherches Cliniques de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: blood glucose; blood insulin; Starch; cereal products; glucose kinetics
• Other Study ID Numbers: KBE032