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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01870570




Registration number
NCT01870570
Ethics application status
Date submitted
3/06/2013
Date registered
6/06/2013
Date last updated
21/08/2014

Titles & IDs
Public title
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Food Products in 3 Separate Research Centers
Scientific title
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers
Secondary ID [1] 0 0
KBE019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemia 0 0
Insulinemia 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: Reference Glucose - Glucose Standard (50g of Glucose)

Experimental: Food Product A: Corn Flakes - Corn Flakes

Experimental: Food Product B: Ginger Bread - Ginger Bread

Experimental: Food Product C:Sandwiched Breakfast Biscuit - Sandwiched Breakfast Biscuit

Experimental: Food Product D: Crackers Nature - Crackers Nature

Experimental: Food Product E: Breakfast Biscuit - Breakfast Biscuit

Experimental: Food Product F: White Bread - White Bread
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
Timepoint [1] 0 0
0-120 minutes
Secondary outcome [1] 0 0
Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products
Timepoint [1] 0 0
0-120 minutes
Secondary outcome [2] 0 0
Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products
Timepoint [2] 0 0
0-120 minutes
Secondary outcome [3] 0 0
Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products
Timepoint [3] 0 0
0-120 minutes
Secondary outcome [4] 0 0
Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products
Timepoint [4] 0 0
0-120 minutes
Secondary outcome [5] 0 0
Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products
Timepoint [5] 0 0
01-20 minutes
Secondary outcome [6] 0 0
Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products
Timepoint [6] 0 0
0-120 minutes
Secondary outcome [7] 0 0
Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products
Timepoint [7] 0 0
0-120 minutes
Secondary outcome [8] 0 0
Determine the Intra-Laboratory Variability for the iAUC of Glycaemia
Timepoint [8] 0 0
0-120 minutes
Secondary outcome [9] 0 0
Determine the Intra-Laboratory Variability of the iAUC of Insulinemia
Timepoint [9] 0 0
0-120 minutes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2013
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Human Nutrition Unit, The University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
France
State/province [2] 0 0
Saint Herblain

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mondelez International, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
BioFortis
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Glycemic Index Laboratories, Inc
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sydney
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01870570
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Gendre, Dr.
Address 0 0
BioFortis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01870570