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Completed

NCT Number: NCT02323542

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutrition intervention with cereal products

Other

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

Primary outcomes

  1. Rate of appearance of exogenous glucose (RaE)

    Time frame: T0 to 300 minutes

    Postprandial kinetic of RaE

Secondary outcomes

  1. iAUC RaE

    Time frame: T0 to 300 minutes

    iAUC of RaE over selected intervals over the 300-minute postprandial period

  2. 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)

    Time frame: T0 to 300 minutes

    Postprandial kinetics of RdE, RaT, RdT and EGP

  3. iAUC of RdE, RaT, RdT and EGP

    Time frame: T0 to 300 minutes

    iAUC of RdE, RaT and RdT and dAUC of EGP over selected intervals over the 300-minute postprandial period

  4. kinetics of glycemia and insulinemia

    Time frame: T-120 to 300 minutes

    Pre- and postprandial kinetics of glycemia and insulinemia

  5. iAUC of glycemia and insulinemia

    Time frame: T0 to 300 minutes

    iAUC of glycemia and insulinemia over selected intervals over the 300-minute postprandial period

  6. Kinetics of plasma glucose-dependent insulinotropic peptide (GIP) concentration

    Time frame: T0 to 300 minutes

    Postprandial kinetic of GIP

  7. iAUC of GIP

    Time frame: T0 to 300 minutes

    iAUC of GIP over selected intervals over the 300-minute postprandial period

  8. Kinetics of plasma FFA concentration

    Time frame: T0 to 300 minutes

    Postprandial kinetic of FFA

  9. dAUC of FFA

    Time frame: T0 to 300 minutes

    dAUC of FFA over selected intervals over the 300-minute postprandial period

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • BioFortis
  • Centre de Recherche en Nutrition Humaine Rhone-Alpe
  • Institut de Recherches Cliniques de Montreal
  • MedQualis

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.