Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers

Not Applicable

Completed

• Conditions: Insulinemia; Glycaemia
• Interventions: Other: Reference Glucose

• Registration Number: NCT01870570
• Lead Sponsor: Mondelēz International, Inc.

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference Glucose	Reference Glucose	Glucose Standard (50g of Glucose)

Primary Outcome Measures

Name	Time	Method
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products	0-120 minutes

Secondary Outcome Measures

Name	Time	Method
Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products	0-120 minutes
Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products	0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products	0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products	0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products	01-20 minutes
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia	0-120 minutes
Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products	0-120 minutes
Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products	0-120 minutes
Determine the Intra-Laboratory Variability for the iAUC of Glycaemia	0-120 minutes

Trial Locations

Locations (3)

Human Nutrition Unit, The University of Sydney; 🇦🇺 Sydney, Australia

Glycemic Index Laboratories; 🇨🇦 Toronto, Ontario, Canada

Biofortis; 🇫🇷 Saint Herblain, France