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

Metabolic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650674
• Other study ID #: KBE043
• Status: Completed
• Phase: N/A
• First received: October 30, 2015
• Last updated: September 13, 2017
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: September 2017
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolic Disorder

Intervention

Other:
• Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
• Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
• Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
• Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
• Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
• Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Mondelez International, Inc.	University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic index values of five cereal products	Determination of GI in both Caucasian and Asian subjects	2 hours after food consumption
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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