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

NCT ID: NCT01870570

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Glycaemia; Insulinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Reference Glucose

Glucose Standard (50g of Glucose)

Group Type: OTHER

Reference Glucose

Intervention Type: OTHER

Food Product A: Corn Flakes

Corn Flakes

Group Type: EXPERIMENTAL

Food Product A: Corn Flakes

Intervention Type: OTHER

Food Product B: Ginger Bread

Ginger Bread

Group Type: EXPERIMENTAL

Food Product B: Ginger Bread

Intervention Type: OTHER

Food Product C:Sandwiched Breakfast Biscuit

Sandwiched Breakfast Biscuit

Group Type: EXPERIMENTAL

Food Product C:Sandwiched Breakfast Biscuit

Intervention Type: OTHER

Food Product D: Crackers Nature

Crackers Nature

Group Type: EXPERIMENTAL

Food Product D: Crackers Nature

Intervention Type: OTHER

Food Product E: Breakfast Biscuit

Breakfast Biscuit

Group Type: EXPERIMENTAL

Food Product E: Breakfast Biscuit

Intervention Type: OTHER

Food Product F: White Bread

White Bread

Group Type: EXPERIMENTAL

Food Product F: White Bread

Intervention Type: OTHER

Interventions

Reference Glucose

Intervention Type: OTHER

Food Product A: Corn Flakes

Intervention Type: OTHER

Food Product B: Ginger Bread

Intervention Type: OTHER

Food Product C:Sandwiched Breakfast Biscuit

Intervention Type: OTHER

Food Product D: Crackers Nature

Intervention Type: OTHER

Food Product E: Breakfast Biscuit

Intervention Type: OTHER

Food Product F: White Bread

Intervention Type: OTHER

Other Intervention Names

Glucose Standard (50g of Glucose); Corn Flakes; Ginger Bread; Sandwiched Breakfast Biscuit; Crackers Nature; Breakfast Biscuit; White Bread

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

Mondelēz International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Gendre, Dr.

Role: PRINCIPAL_INVESTIGATOR

BioFortis

Thomas Wolever, Dr.

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Jennie Brand Miller, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Human Nutrition Unit, The University of Sydney

Sydney, , Australia

Glycemic Index Laboratories

Toronto, Ontario, Canada

Biofortis

Saint-Herblain, , France

Countries

Australia; Canada; France

Other Identifiers

KBE019

Identifier Type: -

Identifier Source: org_study_id