Clinical trial NCT01870570: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers
Official title: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycaemia
Insulinemia
Keywords: Glycaemia
Insulinemia
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
name: Glycemic Index Laboratories, Inc
name: University of Sydney
First posted: 2013-06-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.

Detailed description: This study will be performed at 3 centers and 15 subjects will be recruited at each center.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-35 years inclusive.
2. Non-smoker.
3. BMI 19.0-25.0 kg/m2 inclusive.
4. Healthy subjects with:

   * Fasting plasma glucose \< 5,6 mM (ADA criteria,2011)
   * Insulin resistance index based on homeostasis model assessment (HOMA-IR) \<1.70
   * Fasting lipids: triglyceride \<1.70mmol/L, LDL-cholesterol\<5.00 mmol/L and HDL-cholesterol \>1.03mmol/L for males or \>1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
   * Gamma-GT, AST and ALT \<1.5 times the upper limit of normal (ULN)
   * Complete blood count: Normal full blood count according to the investigator
   * Systolic blood pressure \<130 mmHg
   * Diastolic blood pressure \<85 mmHg
   * Resting heart rate 50-90 beats per minutes (after 3 minutes rest).
5. Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
6. 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))
7. Able to fast for at least 10 hours the night before each test session.
8. Able to refrain from eating legumes and drinking alcohol the day before each test session.
9. Subject covered by social security or covered by a similar system
10. Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
11. Subject having given written consent to take part in the study

Exclusion Criteria:

1. Following a restrictive or specific diet.
2. Suffering from any inflammatory or metabolic diseases
3. Suffering from mental illness.
4. Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
5. Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
6. Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
7. Subject having taken part in another clinical trial within the last week.
8. Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
9. Subject undergoing general anaesthesia in the month prior to inclusion.
10. 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: Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products
timeFrame: 01-20 minutes
measure: Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products
timeFrame: 0-120 minutes
measure: Determine the Intra-Laboratory Variability for the iAUC of Glycaemia
timeFrame: 0-120 minutes
measure: Determine the Intra-Laboratory Variability of the iAUC of Insulinemia
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Human Nutrition Unit, The University of Sydney
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
state: Ontario
city: Saint Herblain
country: France
facility: Biofortis
Study officials:
affiliation: BioFortis
name: David Gendre, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Jennie Brand Miller, Dr.
role: PRINCIPAL_INVESTIGATOR
References: