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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Disorder
• Intervention / Treatment: Other: Product A: NP-0148; Other: Product B: NP-0149; Other: Product C: NP-0150; Other: Product D: NP-0151; Other: Product E: NP-0152; Other: Glucose solution

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: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic response assessed by the glycemic index (GI) values of five cereal products	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	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	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	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	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	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	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	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	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	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	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	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	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	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	This parameter will be analyzed first in both Caucasian and Asian populations and second globally	2 hours after food consumption

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: University of Sydney
• Investigators: Principal Investigator: Jennie Brand Miller, University of Sydney

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 30, 2015
• First Submitted That Met QC Criteria: January 6, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Nutrition; Absorption; Carbohydrate; Intestine; SDS; glycemic & insulin response; cereal product
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: KBE043