Status:
COMPLETED
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers
Lead Sponsor:
Mondelēz International, Inc.
Collaborating Sponsors:
BioFortis
Glycemic Index Laboratories, Inc
Conditions:
Glycaemia
Insulinemia
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.
Detailed Description
This study will be performed at 3 centers and 15 subjects will be recruited at each center.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01870570
Start Date
June 1 2013
End Date
December 1 2013
Last Update
August 21 2014
Active Locations (3)
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1
Human Nutrition Unit, The University of Sydney
Sydney, Australia, 2006
2
Glycemic Index Laboratories
Toronto, Ontario, Canada, M5C 2N8
3
Biofortis
Saint-Herblain, France