CClinicalTrials.gg
CompletedNCT02323542Updated Sep 14, 2017

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

An interventional study of Nutrition intervention with cereal products in Blood Glucose Kinetics, sponsored by Mondelēz International, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-14.

Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Blood Glucose Kinetics

Keywords

  • Starch
  • cereal products
  • glucose kinetics
  • blood glucose
  • blood insulin
03

In context

Lead sponsor

Mondelēz International, Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    High-SDS biscuit

    Biscuit with high Slowly Digestible Starch content

    Other: Nutrition intervention with cereal products

  • Active comparator
    Low-SDS cereal product

    Cereal product with low Slowly Digestible Starch content

    Other: Nutrition intervention with cereal products

Interventions

  • OtherNutrition intervention with cereal products

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

06

What researchers measure

Primary outcomes

  1. Rate of appearance of exogenous glucose (RaE)

    Postprandial kinetic of RaE

    Time frame: T0 to 300 minutes

Secondary outcomes

  1. iAUC RaE

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

    Time frame: T0 to 300 minutes

  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)

    Postprandial kinetics of RdE, RaT, RdT and EGP

    Time frame: T0 to 300 minutes

  3. 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

    Time frame: T0 to 300 minutes

  4. kinetics of glycemia and insulinemia

    Pre- and postprandial kinetics of glycemia and insulinemia

    Time frame: T-120 to 300 minutes

  5. iAUC of glycemia and insulinemia

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

    Time frame: T0 to 300 minutes

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

    Postprandial kinetic of GIP

    Time frame: T0 to 300 minutes

  7. iAUC of GIP

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

    Time frame: T0 to 300 minutes

  8. Kinetics of plasma FFA concentration

    Postprandial kinetic of FFA

    Time frame: T0 to 300 minutes

  9. dAUC of FFA

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

    Time frame: T0 to 300 minutes

07

Study locations

1 site
  • Institut de Recherches Cliniques de Montréal
    Montréal, Quebec H2W1R7, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02323542
Lead sponsor
Mondelēz International, Inc.
Collaborators
Institut de Recherches Cliniques de Montreal, Centre de Recherche en Nutrition Humaine Rhone-Alpe, BioFortis, MedQualis
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Apr 2015
Primary completion
Dec 2015
Completion
Apr 2016
Last update
Sep 14, 2017

Study contacts

Remi Rabasa-Llhoret, MD, PhD
principal investigator · Institut de Recherches Cliniques de Montreal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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