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

This study is currently recruiting participants.
Verified June 2013 by Mondelēz International, Inc.
Sponsor:
Collaborators:
BioFortis
Glycemic Index Laboratories, Inc
University of Sydney
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01870570
First received: June 3, 2013
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Glycaemia
Insulinemia
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers

Resource links provided by NLM:


Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products [ Time Frame: 01-20 minutes ] [ Designated as safety issue: No ]
  • Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine the Intra-Laboratory Variability for the iAUC of Glycaemia [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
  • Determine the Intra-Laboratory Variability of the iAUC of Insulinemia [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Reference Glucose
Glucose Standard (50g of Glucose)
Other: Reference Glucose
Other Name: Glucose Standard (50g of Glucose)
Experimental: Food Product A: Corn Flakes
Corn Flakes
Other: Food Product A: Corn Flakes
Other Name: Corn Flakes
Experimental: Food Product B: Ginger Bread
Ginger Bread
Other: Food Product B: Ginger Bread
Other Name: Ginger Bread
Experimental: Food Product C:Sandwiched Breakfast Biscuit
Sandwiched Breakfast Biscuit
Other: Food Product C:Sandwiched Breakfast Biscuit
Other Name: Sandwiched Breakfast Biscuit
Experimental: Food Product D: Crackers Nature
Crackers Nature
Other: Food Product D: Crackers Nature
Other Name: Crackers Nature
Experimental: Food Product E: Breakfast Biscuit
Breakfast Biscuit
Other: Food Product E: Breakfast Biscuit
Other Name: Breakfast Biscuit
Experimental: Food Product F: White Bread
White Bread
Other: Food Product F: White Bread
Other Name: White Bread

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870570

Contacts
Contact: Alexandra Meynier, Dr. 0033 1 60 1975 74 alexandra.meynier@mdlz.com

Locations
Australia
Human Nutrition Unit, The University of Sydney Recruiting
Sydney, Australia, 2006
Contact: Fiona Atkinson, Dr.    +61 293516018    fiona.atkinson@sydney.edu.au   
Principal Investigator: Jennie Brand Miller, Dr.         
Sub-Investigator: Fiona Atkinson, Dr.         
Canada, Ontario
Glycemic Index Laboratories Recruiting
Toronto, Ontario, Canada, M5C 2N8
Contact: Thomas Wolever, Dr.    416-861-0506    thomas.wolever@utoronto.ca   
Contact: Alexandra Jenkins, Dr.    416-861-9782    alexandrajenkins@gilabs.com   
Principal Investigator: Thomas Wolever, Dr.         
Sub-Investigator: Alexandra jenkins, Dr.         
Sub-Investigator: Vladmir Vuksan, Dr.         
France
Biofortis Recruiting
Saint Herblain, France
Contact: Guillaume Talourd    +33 240202326    guillaume.talourd@mxns.com   
Principal Investigator: David Gendre, Dr.         
Sponsors and Collaborators
Mondelēz International, Inc.
BioFortis
Glycemic Index Laboratories, Inc
University of Sydney
Investigators
Principal Investigator: David Gendre, Dr. BioFortis
Principal Investigator: Thomas Wolever, Dr. Glycemic Index Laboratories, Inc
Principal Investigator: Jennie Brand Miller, Dr. The University of Sydney
  More Information

No publications provided

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01870570     History of Changes
Other Study ID Numbers: KBE019
Study First Received: June 3, 2013
Last Updated: June 5, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Mondelēz International, Inc.:
Glycaemia
Insulinemia

ClinicalTrials.gov processed this record on April 20, 2014