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

This study has been completed.
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: August 20, 2014
Last verified: August 2014
  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 ]

Enrollment: 48
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870570

Locations
Australia
Human Nutrition Unit, The University of Sydney
Sydney, Australia, 2006
Canada, Ontario
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2N8
France
Biofortis
Saint Herblain, France
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: August 20, 2014
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 November 19, 2014