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

NCT01870570 | Completed

• 1 other identifier: KBE019
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 3

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.

Conditions

Glycaemia; Insulinemia

Keywords

Glycaemia; Insulinemia

Outcome Measures

Primary Outcomes (1)

• Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products

  0-120 minutes

Secondary Outcomes (9)

• 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

Study Arms (7)

Reference Glucose

OTHER

Glucose Standard (50g of Glucose)

Other: Reference Glucose

Food Product A: Corn Flakes

EXPERIMENTAL

Corn Flakes

Other: Food Product A: Corn Flakes

Food Product B: Ginger Bread

EXPERIMENTAL

Ginger Bread

Other: Food Product B: Ginger Bread

Food Product C:Sandwiched Breakfast Biscuit

EXPERIMENTAL

Sandwiched Breakfast Biscuit

Other: Food Product C:Sandwiched Breakfast Biscuit

Food Product D: Crackers Nature

EXPERIMENTAL

Crackers Nature

Other: Food Product D: Crackers Nature

Food Product E: Breakfast Biscuit

EXPERIMENTAL

Breakfast Biscuit

Other: Food Product E: Breakfast Biscuit

Food Product F: White Bread

EXPERIMENTAL

White Bread

Other: Food Product F: White Bread

Interventions

Reference Glucose OTHER

Also known as: Glucose Standard (50g of Glucose)

Reference Glucose

Food Product A: Corn Flakes OTHER

Also known as: Corn Flakes

Food Product A: Corn Flakes

Food Product B: Ginger Bread OTHER

Also known as: Ginger Bread

Food Product B: Ginger Bread

Food Product C:Sandwiched Breakfast Biscuit OTHER

Also known as: Sandwiched Breakfast Biscuit

Food Product C:Sandwiched Breakfast Biscuit

Food Product D: Crackers Nature OTHER

Also known as: Crackers Nature

Food Product D: Crackers Nature

Food Product E: Breakfast Biscuit OTHER

Also known as: Breakfast Biscuit

Food Product E: Breakfast Biscuit

Food Product F: White Bread OTHER

Also known as: White Bread

Food Product F: White Bread

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-35 years inclusive.
• Non-smoker.
• BMI 19.0-25.0 kg/m2 inclusive.
• 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).
• Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
• 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))
• Able to fast for at least 10 hours the night before each test session.

You may not qualify if:

• Following a restrictive or specific diet.
• Suffering from any inflammatory or metabolic diseases
• Suffering from mental illness.
• Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
• Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
• Subject having taken part in another clinical trial within the last week.
• 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.

Sponsors & Collaborators

• Mondelēz International, Inc.: lead
• BioFortis: collaborator
• Glycemic Index Laboratories, Inc: collaborator
• University of Sydney: collaborator

Study Sites (3)

Human Nutrition Unit, The University of Sydney

Sydney, 2006, Australia

Location

Glycemic Index Laboratories

Toronto, Ontario, M5C 2N8, Canada

Location

Biofortis

Saint-Herblain, France

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• David Gendre, Dr.

  BioFortis

  PRINCIPAL INVESTIGATOR

• Thomas Wolever, Dr.

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

• Jennie Brand Miller, Dr.

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

AU (1); CA (1); FR (1)