NCT02323542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

December 18, 2014

Last Update Submit

September 13, 2017

Conditions

Blood Glucose Kinetics

Keywords

Starchcereal productsglucose kineticsblood glucoseblood insulin

Outcome Measures

Primary Outcomes (1)

  • Rate of appearance of exogenous glucose (RaE)

    Postprandial kinetic of RaE

    T0 to 300 minutes

Secondary Outcomes (9)

  • iAUC RaE

    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)

    T0 to 300 minutes

  • iAUC of RdE, RaT, RdT and EGP

    T0 to 300 minutes

  • kinetics of glycemia and insulinemia

    T-120 to 300 minutes

  • iAUC of glycemia and insulinemia

    T0 to 300 minutes

  • +4 more secondary outcomes

Study Arms (2)

High-SDS biscuit

EXPERIMENTAL

Biscuit with high Slowly Digestible Starch content

Other: Nutrition intervention with cereal products

Low-SDS cereal product

ACTIVE COMPARATOR

Cereal product with low Slowly Digestible Starch content

Other: Nutrition intervention with cereal products

Interventions

Nutrition intervention with cereal productsOTHER

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

High-SDS biscuitLow-SDS cereal product

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Remi Rabasa-Llhoret, MD, PhD

    Institut de Recherches Cliniques de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

CA(1)