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Completed

NCT Number: NCT01870570

Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food 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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Unit, The University of Sydney, Sydney, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Able to refrain from eating legumes and drinking alcohol the day before each test session.
  • Subject covered by social security or covered by a similar system
  • Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
  • Subject having given written consent to take part in the study

Exclusion criteria

  • 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).
  • Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
  • 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 currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
  • Subject undergoing general anaesthesia in the month prior to inclusion.
  • 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.

Treatment and study plan

Reference Glucose

Other

Other names: Glucose Standard (50g of Glucose)

Food Product A: Corn Flakes

Other

Other names: Corn Flakes

Food Product B: Ginger Bread

Other

Other names: Ginger Bread

Food Product C:Sandwiched Breakfast Biscuit

Other

Other names: Sandwiched Breakfast Biscuit

Food Product D: Crackers Nature

Other

Other names: Crackers Nature

Food Product E: Breakfast Biscuit

Other

Other names: Breakfast Biscuit

Food Product F: White Bread

Other

Other names: White Bread

Primary outcomes

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

    Time frame: 0-120 minutes

Secondary outcomes

  1. 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

  2. Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products

    Time frame: 0-120 minutes

  3. Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products

    Time frame: 0-120 minutes

  4. Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products

    Time frame: 0-120 minutes

  5. 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

  6. Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products

    Time frame: 0-120 minutes

  7. Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products

    Time frame: 0-120 minutes

  8. Determine the Intra-Laboratory Variability for the iAUC of Glycaemia

    Time frame: 0-120 minutes

  9. Determine the Intra-Laboratory Variability of the iAUC of Insulinemia

    Time frame: 0-120 minutes

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • BioFortis
  • Glycemic Index Laboratories, Inc
  • University of Sydney

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2013
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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