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

Primary Purpose

Metabolic Disorder

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Product A: NP-0148
Glucose solution
Product B: NP-0149
Product C: NP-0150
Product D: NP-0151
Product E: NP-0152
Sponsored by
Mondelēz International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Disorder focused on measuring glycemic & insulin response, SDS, cereal product, Nutrition, Carbohydrate, Absorption, Intestine

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Sydney

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Product A: NP-0148

Product B: NP-0149

Product C: NP-0150

Product D: NP-0151

Product E: NP-0152

Glucose reference

Arm Description

Cereal product belVita Milk & Cereals - High in SDS

Cereal product belVita Honey & Nuts - High in SDS

Cereal product belVita Mixed Berry - High in SDS

Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat

Cereal product Kellogg's Trésor Duo Choco - Low in SDS

Glucose solution performed on three occasions

Outcomes

Primary Outcome Measures

Glycaemic index values of five cereal products
Determination of GI in both Caucasian and Asian subjects

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2015
Last Updated
September 13, 2017
Sponsor
Mondelēz International, Inc.
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT02650674
Brief Title
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Official Title
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mondelēz International, Inc.
Collaborators
University of Sydney

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disorder
Keywords
glycemic & insulin response, SDS, cereal product, Nutrition, Carbohydrate, Absorption, Intestine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Product A: NP-0148
Arm Type
Experimental
Arm Description
Cereal product belVita Milk & Cereals - High in SDS
Arm Title
Product B: NP-0149
Arm Type
Experimental
Arm Description
Cereal product belVita Honey & Nuts - High in SDS
Arm Title
Product C: NP-0150
Arm Type
Experimental
Arm Description
Cereal product belVita Mixed Berry - High in SDS
Arm Title
Product D: NP-0151
Arm Type
Experimental
Arm Description
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
Arm Title
Product E: NP-0152
Arm Type
Experimental
Arm Description
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
Arm Title
Glucose reference
Arm Type
Experimental
Arm Description
Glucose solution performed on three occasions
Intervention Type
Other
Intervention Name(s)
Product A: NP-0148
Intervention Description
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Intervention Type
Other
Intervention Name(s)
Glucose solution
Intervention Description
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
Intervention Type
Other
Intervention Name(s)
Product B: NP-0149
Intervention Description
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Intervention Type
Other
Intervention Name(s)
Product C: NP-0150
Intervention Description
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Intervention Type
Other
Intervention Name(s)
Product D: NP-0151
Intervention Description
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Intervention Type
Other
Intervention Name(s)
Product E: NP-0152
Intervention Description
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
Primary Outcome Measure Information:
Title
Glycaemic index values of five cereal products
Description
Determination of GI in both Caucasian and Asian subjects
Time Frame
2 hours after food consumption
Secondary Outcome Measure Information:
Title
Glycaemic response assessed by the glycemic index (GI) values of five cereal products
Description
Determination of GI in the global population
Time Frame
2 hours after food consumption
Title
Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Glycaemic response assessed by the peak value of glycemia
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Glycaemic response assessed by the delta value between baseline and peak values of glycemia
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulinaemic response assessed by the peak value of insulinemia
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Insulin / glucose ratio (II/GI) evaluation of five cereal products
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Kinetic of insulin / glucose over the 120 minutes
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Peak value of insulin / glucose ratio
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption
Title
Delta peak value between baseline and peak values of insulin / glucose ratio
Description
This parameter will be analyzed first in both Caucasian and Asian populations and second globally
Time Frame
2 hours after food consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie Brand Miller
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2006
Country
Australia

12. IPD Sharing Statement

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

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