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Completed

NCT Number: NCT02650674

Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sydney

Sydney, New South Wales, 2006, Australia

About this study

This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged between 18-45 years.
  • Non-smoker.
  • BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
  • Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
  • Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
  • Healthy subjects with:

Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal 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 diet.
  • Family history of Diabetes Mellitus or obesity
  • Suffering from any clinical, physical or mental illness.
  • Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
  • Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
  • Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
  • Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
  • 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

Product A: NP-0148

Other

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

glucose solution

Other

Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times

Product B: NP-0149

Other

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product C: NP-0150

Other

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product D: NP-0151

Other

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Product E: NP-0152

Other

Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Primary outcomes

  1. Glycaemic index values of five cereal products

    Time frame: 2 hours after food consumption

    Determination of GI in both Caucasian and Asian subjects

Secondary outcomes

  1. Glycaemic response assessed by the glycemic index (GI) values of five cereal products

    Time frame: 2 hours after food consumption

    Determination of GI in the global population

  2. Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  3. Glycaemic response assessed by the kinetic of glycemia over the 120 minutes

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  4. Glycaemic response assessed by the peak value of glycemia

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  5. Glycaemic response assessed by the delta value between baseline and peak values of glycemia

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  6. Insulinaemic response assessed by the insulinemic index (II) values of five cereal products

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  7. Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  8. Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  9. Insulinaemic response assessed by the peak value of insulinemia

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  10. Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  11. Insulin / glucose ratio (II/GI) evaluation of five cereal products

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  12. Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  13. Kinetic of insulin / glucose over the 120 minutes

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  14. Peak value of insulin / glucose ratio

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

  15. Delta peak value between baseline and peak values of insulin / glucose ratio

    Time frame: 2 hours after food consumption

    This parameter will be analyzed first in both Caucasian and Asian populations and second globally

Sponsors and collaborators

Lead sponsor

Mondelēz International, Inc.

Industry

Collaborators

  • University of Sydney

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2016
Registry last updated
Sep 14, 2017

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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