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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00260858




Registration number
NCT00260858
Ethics application status
Date submitted
30/11/2005
Date registered
2/12/2005
Date last updated
9/06/2006

Titles & IDs
Public title
GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods
Scientific title
Measuring the Glycaemic Index of Foods: Interlaboratory Study #2
Secondary ID [1] 0 0
GIL5047
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Test Meal: Reference food (glucose or white bread)
Treatment: Drugs - Test Meal: Pirate's Booty
Treatment: Drugs - Test Meal: Ceaprove wafer
Treatment: Drugs - Test Meal: Stretch Island Strawberry Fruit Leather

Treatment: Drugs: Test Meal: Reference food (glucose or white bread)


Treatment: Drugs: Test Meal: Pirate's Booty


Treatment: Drugs: Test Meal: Ceaprove wafer


Treatment: Drugs: Test Meal: Stretch Island Strawberry Fruit Leather
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
glycaemic index
Timepoint [1] 0 0
Secondary outcome [1] 0 0
within-individual variation of glycaemic responses
Timepoint [1] 0 0
Secondary outcome [2] 0 0
glycaemic responses assessed as incremental area under the curve
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- Healthy male or female subjects
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diabetes

- Pregnancy or lactation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment hospital [2] 0 0
International Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
3162 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
Finland
State/province [7] 0 0
Helsinki
Country [8] 0 0
Finland
State/province [8] 0 0
Kuopio
Country [9] 0 0
France
State/province [9] 0 0
Nantes
Country [10] 0 0
Germany
State/province [10] 0 0
Nuthetal
Country [11] 0 0
Italy
State/province [11] 0 0
Milan
Country [12] 0 0
Italy
State/province [12] 0 0
Parma
Country [13] 0 0
Malaysia
State/province [13] 0 0
Kelantan
Country [14] 0 0
Netherlands
State/province [14] 0 0
Maastricht
Country [15] 0 0
New Zealand
State/province [15] 0 0
Otago
Country [16] 0 0
Philippines
State/province [16] 0 0
Diliman
Country [17] 0 0
South Africa
State/province [17] 0 0
Mpumalanga
Country [18] 0 0
South Africa
State/province [18] 0 0
Potchesfstroom
Country [19] 0 0
Sweden
State/province [19] 0 0
Gotheburg
Country [20] 0 0
Sweden
State/province [20] 0 0
Lund
Country [21] 0 0
Trinidad and Tobago
State/province [21] 0 0
Trinidad
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Berkshire
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Oxfordshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Surrey
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Glycaemic Index Testing, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sydney University Glycaemic Index Research Services
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ILSI Europe
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the extent of and sources of variation in the
glycaemic index values of foods measured by different laboratories around the world.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00260858
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas MS Wolever, MD, PhD
Address 0 0
University of Toronto
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/ct2/show/NCT00260858