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

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ClinicalTrials.gov Identifier: NCT02650674
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Mondelēz International, Inc.

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

Condition or disease Intervention/treatment Phase
Metabolic Disorder Other: Product A: NP-0148 Other: Glucose solution Other: Product B: NP-0149 Other: Product C: NP-0150 Other: Product D: NP-0151 Other: Product E: NP-0152 Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Product A: NP-0148
Cereal product belVita Milk & Cereals - High in SDS
Other: Product A: NP-0148
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Experimental: Product B: NP-0149
Cereal product belVita Honey & Nuts - High in SDS
Other: Product B: NP-0149
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Experimental: Product C: NP-0150
Cereal product belVita Mixed Berry - High in SDS
Other: Product C: NP-0150
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Experimental: Product D: NP-0151
Cereal product Kellogg's Corn Flakes - Low in SDS - Low in fat
Other: Product D: NP-0151
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Experimental: Product E: NP-0152
Cereal product Kellogg's Trésor Duo Choco - Low in SDS
Other: Product E: NP-0152
Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.

Experimental: Glucose reference
Glucose solution performed on three occasions
Other: Glucose solution
Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650674


Locations
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Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
Mondelēz International, Inc.
University of Sydney
Investigators
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Principal Investigator: Jennie Brand Miller University of Sydney

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Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT02650674     History of Changes
Other Study ID Numbers: KBE043
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Mondelēz International, Inc.:
glycemic & insulin response
SDS
cereal product
Nutrition
Carbohydrate
Absorption
Intestine

Additional relevant MeSH terms:
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Metabolic Diseases
Pharmaceutical Solutions