Trial Review

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Trial details imported from ClinicalTrials.gov

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00260858