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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323542
Enrollment
41
Registered
2014-12-23
Start date
2015-04-30
Completion date
2016-04-30
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose Kinetics

Keywords

Starch, cereal products, glucose kinetics, blood glucose, blood insulin

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

Interventions

OTHERNutrition intervention with cereal products

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

Sponsors

Institut de Recherches Cliniques de Montreal
CollaboratorOTHER
Centre de Recherche en Nutrition Humaine Rhone-Alpe
CollaboratorOTHER
BioFortis
CollaboratorOTHER
MedQualis
CollaboratorINDUSTRY
Mondelēz International, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of appearance of exogenous glucose (RaE)T0 to 300 minutesPostprandial kinetic of RaE

Secondary

MeasureTime frameDescription
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 minutesPostprandial kinetics of RdE, RaT, RdT and EGP
iAUC of RdE, RaT, RdT and EGPT0 to 300 minutesiAUC of RdE, RaT and RdT and dAUC of EGP over selected intervals over the 300-minute postprandial period
kinetics of glycemia and insulinemiaT-120 to 300 minutesPre- and postprandial kinetics of glycemia and insulinemia
iAUC of glycemia and insulinemiaT0 to 300 minutesiAUC of glycemia and insulinemia over selected intervals over the 300-minute postprandial period
iAUC RaET0 to 300 minutesiAUC of RaE over selected intervals over the 300-minute postprandial period
iAUC of GIPT0 to 300 minutesiAUC of GIP over selected intervals over the 300-minute postprandial period
Kinetics of plasma FFA concentrationT0 to 300 minutesPostprandial kinetic of FFA
dAUC of FFAT0 to 300 minutesdAUC of FFA over selected intervals over the 300-minute postprandial period
Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentrationT0 to 300 minutesPostprandial kinetic of GIP

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026