Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers

August 20, 2014 updated by: Mondelēz International, Inc.

Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers

The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be performed at 3 centers and 15 subjects will be recruited at each center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Sydney, Australia, 2006
        • Human Nutrition Unit, The University of Sydney
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C 2N8
        • Glycemic Index Laboratories
  • France
      • Saint Herblain, France
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18-35 years inclusive.
  2. Non-smoker.
  3. BMI 19.0-25.0 kg/m2 inclusive.

  4. Healthy subjects with:

    • Fasting plasma glucose < 5,6 mM (ADA criteria,2011)
    • Insulin resistance index based on homeostasis model assessment (HOMA-IR) <1.70
    • Fasting lipids: triglyceride <1.70mmol/L, LDL-cholesterol<5.00 mmol/L and HDL-cholesterol >1.03mmol/L for males or >1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
    • Gamma-GT, AST and ALT <1.5 times the upper limit of normal (ULN)
    • Complete blood count: Normal full blood count according to the investigator
    • Systolic blood pressure <130 mmHg
    • Diastolic blood pressure <85 mmHg
    • Resting heart rate 50-90 beats per minutes (after 3 minutes rest).
  5. Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
  6. Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
  7. Able to fast for at least 10 hours the night before each test session.
  8. Able to refrain from eating legumes and drinking alcohol the day before each test session.
  9. Subject covered by social security or covered by a similar system
  10. Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
  11. Subject having given written consent to take part in the study

Exclusion Criteria:

  1. Following a restrictive or specific diet.
  2. Suffering from any inflammatory or metabolic diseases
  3. Suffering from mental illness.
  4. Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
  5. Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
  6. Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
  7. Subject having taken part in another clinical trial within the last week.
  8. Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
  9. Subject undergoing general anaesthesia in the month prior to inclusion.
  10. Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Reference Glucose
Glucose Standard (50g of Glucose)
Other: Reference Glucose
Other Names:
  • Glucose Standard (50g of Glucose)
EXPERIMENTAL: Food Product A: Corn Flakes
Corn Flakes
Other: Food Product A: Corn Flakes
Other Names:
  • Corn Flakes
EXPERIMENTAL: Food Product B: Ginger Bread
Ginger Bread
Other: Food Product B: Ginger Bread
Other Names:
  • Ginger Bread
EXPERIMENTAL: Food Product C:Sandwiched Breakfast Biscuit
Sandwiched Breakfast Biscuit
Other: Food Product C:Sandwiched Breakfast Biscuit
Other Names:
  • Sandwiched Breakfast Biscuit
EXPERIMENTAL: Food Product D: Crackers Nature
Crackers Nature
Other: Food Product D: Crackers Nature
Other Names:
  • Crackers Nature
EXPERIMENTAL: Food Product E: Breakfast Biscuit
Breakfast Biscuit
Other: Food Product E: Breakfast Biscuit
Other Names:
  • Breakfast Biscuit
EXPERIMENTAL: Food Product F: White Bread
White Bread
Other: Food Product F: White Bread
Other Names:
  • White Bread

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products
Time Frame: 01-20 minutes
01-20 minutes
Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products
Time Frame: 0-120 minutes
0-120 minutes
Determine the Intra-Laboratory Variability for the iAUC of Glycaemia
Time Frame: 0-120 minutes
0-120 minutes
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia
Time Frame: 0-120 minutes
0-120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mondelēz International, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sydney
Glycemic Index Laboratories, Inc
BioFortis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Gendre, Dr., Biofortis
  • Principal Investigator: Thomas Wolever, Dr., Glycemic Index Laboratories, Inc
  • Principal Investigator: Jennie Brand Miller, Dr., University of Sydney

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KBE019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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