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

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

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

Study Overview

• Status: Completed
• Conditions: Glycaemia; Insulinemia
• Intervention / Treatment: Other: Reference Glucose; Other: Food Product A: Corn Flakes; Other: Food Product B: Ginger Bread; Other: Food Product C:Sandwiched Breakfast Biscuit; Other: Food Product D: Crackers Nature; Other: Food Product E: Breakfast Biscuit; Other: Food Product F: White Bread

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia, 2006
    • Human Nutrition Unit, The University of Sydney
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Glycemic Index Laboratories
• France
  • Saint Herblain, France
    • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Reference Glucose; Glucose Standard (50g of Glucose)	Other: Reference Glucose; Other Names: Glucose Standard (50g of Glucose)
EXPERIMENTAL: Food Product A: Corn Flakes; Corn Flakes	Other: Food Product A: Corn Flakes; Other Names: Corn Flakes
EXPERIMENTAL: Food Product B: Ginger Bread; Ginger Bread	Other: Food Product B: Ginger Bread; Other Names: Ginger Bread
EXPERIMENTAL: Food Product C:Sandwiched Breakfast Biscuit; Sandwiched Breakfast Biscuit	Other: Food Product C:Sandwiched Breakfast Biscuit; Other Names: Sandwiched Breakfast Biscuit
EXPERIMENTAL: Food Product D: Crackers Nature; Crackers Nature	Other: Food Product D: Crackers Nature; Other Names: Crackers Nature
EXPERIMENTAL: Food Product E: Breakfast Biscuit; Breakfast Biscuit	Other: Food Product E: Breakfast Biscuit; Other Names: Breakfast Biscuit
EXPERIMENTAL: Food Product F: White Bread; White Bread	Other: Food Product F: White Bread; Other Names: White Bread

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products	0-120 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Insulinemic Index 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
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
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia	0-120 minutes

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: University of Sydney; Glycemic Index Laboratories, Inc; BioFortis
• Investigators: Principal Investigator: David Gendre, Dr., Biofortis; Principal Investigator: Thomas Wolever, Dr., Glycemic Index Laboratories, Inc; Principal Investigator: Jennie Brand Miller, Dr., University of Sydney

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (ESTIMATE): June 6, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 20, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Insulinemia; Glycaemia
• Other Study ID Numbers: KBE019