Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products

September 13, 2017 updated by: Mondelēz International, Inc.
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.

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 aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.

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.
24

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
    • New South Wales
      • Sydney, New South Wales, Australia, 2006
        • University of Sydney

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 18-45 years.
  • Non-smoker.
  • BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
  • Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
  • Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
  • Healthy subjects with:

Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal resting heart rate (50-90 beats per minutes after 3 minutes rest).

  • Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
  • 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))
  • Able to fast for at least 10 hours the night before each test session.
  • Able to refrain from eating legumes and drinking alcohol the day before each test session.
  • Subject covered by social security or covered by a similar system
  • Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
  • Subject having given written consent to take part in the study.

Exclusion Criteria:

  • Following a restrictive diet.
  • Family history of Diabetes Mellitus or obesity
  • Suffering from any clinical, physical or mental illness.
  • Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
  • Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
  • Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
  • Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
  • Subject having taken part in another clinical trial within the last week.
  • Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
  • Subject undergoing general anaesthesia in the month prior to inclusion.
  • 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 Assignment
  • Masking: None (Open Label)

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.
Experimental: Product A: NP-0148
Cereal product belVita Milk & Cereals - High in SDS
Other: Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimental: Product B: NP-0149
Cereal product belVita Honey & Nuts - High in SDS
Other: Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimental: Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
Other: Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimental: Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
Other: Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimental: Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
Other: Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Experimental: Glucose reference
Glucose solution performed on three occasions
Other: Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times

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
Measure Description
Time Frame
Glycaemic index values of five cereal products
Time Frame: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
2 hours after food consumption

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
Measure Description
Time Frame
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Time Frame: 2 hours after food consumption
Determination of GI in the global population
2 hours after food consumption
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the peak value of glycemia
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the peak value of insulinemia
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Kinetic of insulin / glucose over the 120 minutes
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Peak value of insulin / glucose ratio
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption
Delta peak value between baseline and peak values of insulin / glucose ratio
Time Frame: 2 hours after food consumption
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
2 hours after food consumption

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

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: Jennie Brand Miller, 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.
October 1, 2015

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.
March 1, 2016

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.
April 1, 2016

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).
October 30, 2015

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.
January 6, 2016

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.
January 8, 2016

Study Record Updates

Last Update Posted (Actual)

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.
September 14, 2017

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.
September 13, 2017

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.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • KBE043

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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