Clinical trial NCT02650674: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorder
Keywords: glycemic & insulin response
SDS
cereal product
Nutrition
Carbohydrate
Absorption
Intestine
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Sydney
First posted: 2016-01-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Glycaemic index values of five cereal products
timeFrame: 2 hours after food consumption
Secondary outcomes:
measure: Glycaemic response assessed by the glycemic index (GI) values of five cereal products
timeFrame: 2 hours after food consumption
measure: Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products
timeFrame: 2 hours after food consumption
measure: Glycaemic response assessed by the kinetic of glycemia over the 120 minutes
timeFrame: 2 hours after food consumption
measure: Glycaemic response assessed by the peak value of glycemia
timeFrame: 2 hours after food consumption
measure: Glycaemic response assessed by the delta value between baseline and peak values of glycemia
timeFrame: 2 hours after food consumption
measure: Insulinaemic response assessed by the insulinemic index (II) values of five cereal products
timeFrame: 2 hours after food consumption
measure: Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products
timeFrame: 2 hours after food consumption
measure: Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes
timeFrame: 2 hours after food consumption
measure: Insulinaemic response assessed by the peak value of insulinemia
timeFrame: 2 hours after food consumption
measure: Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia
timeFrame: 2 hours after food consumption
measure: Insulin / glucose ratio (II/GI) evaluation of five cereal products
timeFrame: 2 hours after food consumption
measure: Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products
timeFrame: 2 hours after food consumption
measure: Kinetic of insulin / glucose over the 120 minutes
timeFrame: 2 hours after food consumption
measure: Peak value of insulin / glucose ratio
timeFrame: 2 hours after food consumption
measure: Delta peak value between baseline and peak values of insulin / glucose ratio
timeFrame: 2 hours after food consumption
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Jennie Brand Miller
role: PRINCIPAL_INVESTIGATOR
References: