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

Glycaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870570
• Other study ID #: KBE019
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: August 20, 2014
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: Mondelez International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glycaemia
• Insulinemia

Intervention

Other:
• Reference Glucose

• Food Product A: Corn Flakes

• Food Product B: Ginger Bread

• Food Product C:Sandwiched Breakfast Biscuit

• Food Product D: Crackers Nature

• Food Product E: Breakfast Biscuit

• Food Product F: White Bread

Locations

Country	Name	City	State
Australia	Human Nutrition Unit, The University of Sydney	Sydney
Canada	Glycemic Index Laboratories	Toronto	Ontario
France	Biofortis	Saint Herblain

Sponsors (4)

Lead Sponsor	Collaborator
Mondelez International, Inc.	BioFortis, Glycemic Index Laboratories, Inc, University of Sydney

Countries where clinical trial is conducted

Australia,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products		0-120 minutes	No
Secondary	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	No
Secondary	Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products		0-120 minutes	No
Secondary	Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products		0-120 minutes	No
Secondary	Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products		0-120 minutes	No
Secondary	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	No
Secondary	Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products		0-120 minutes	No
Secondary	Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products		0-120 minutes	No
Secondary	Determine the Intra-Laboratory Variability for the iAUC of Glycaemia		0-120 minutes	No
Secondary	Determine the Intra-Laboratory Variability of the iAUC of Insulinemia		0-120 minutes	No