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NCT00260858 Clinical Trial

GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods

Healthy Clinical Trial

Official title:
Measuring the Glycaemic Index of Foods: Interlaboratory Study #2

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00260858
Other study ID # GIL5047
Secondary ID
Status Completed
Phase N/A
First received November 30, 2005
Last updated June 7, 2006
Start date November 2005
Est. completion date April 2006

Study information
Verified date June 2006
Source Glycaemic Index Testing, Inc.
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Description:

The glycaemic index values of 3 different foods provided from a central location will be determined in each of 20-30 centers around the world. A standard protocol will be followed, but this protocol leaves room for variation in certain details, such as whether subjects are allowed to have coffee or tea with the test meals or only water, or the method of analyzing blood glucose. Methodologic details, subject demographic information (height, weight, age, and ethnicity), results of local calculations and raw data will be sent to a central location.

Recruitment information / eligibility
Status Completed
Enrollment 280
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Healthy male or female subjects

Exclusion Criteria:

- Diabetes

- Pregnancy or lactation

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Test Meal: Reference food (glucose or white bread)

• Test Meal: Pirate's Booty

• Test Meal: Ceaprove wafer

• Test Meal: Stretch Island Strawberry Fruit Leather

Locations
Country Name City State
Australia International Diabetes Institute Melbourne Victoria
Australia University of Sydney Sydney New South Wales
Canada Glycemic Index Laboratories, Inc. Toronto Ontario
China Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention Beijing Beijing
Denmark The Royal Veterinary & Agricultural University Copenhagen
Finland National Public Health Institute Helsinki
Finland Foodfiles Oy Kuopio
France Biofortis Nantes
Germany German Institute of Human Nutrition Potsdam-Rehbrucke Nuthetal
Italy University of Milan Milan
Italy University of Parma Parma
Malaysia University Sains Malaysia Kota Bharu Kelantan
Netherlands Nutriscience, BV Maastricht
New Zealand University of Otago Dunedin Otago
Philippines University of the Philippines Diliman
South Africa GI Foundation of South Africa Nelspruit Mpumalanga
South Africa Potchefstroom University Potchefstroom Potchesfstroom
Sweden Gotheburg University Gothenburg Gotheburg
Sweden Lund University Lund
Trinidad and Tobago University of the West Indies Champs Fleurs Trinidad
United Kingdom University of Surrey Guildford Surrey
United Kingdom Leatherhead Food International Leatherhead Surrey
United Kingdom Hammersmith Hospital London
United Kingdom Oxford Brookes University Oxford Oxfordshire
United Kingdom Reading Scientific Services, Ltd. Reading Berkshire
United States University of Buffalo Buffalo New York
United States Ohio State University Columbus Ohio
United States Abernethy Research Gainsville Florida

Sponsors (3)
Lead Sponsor Collaborator
Glycaemic Index Testing, Inc. ILSI Europe, Sydney University Glycaemic Index Research Services

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Denmark,  Finland,  France,  Germany,  Italy,  Malaysia,  Netherlands,  New Zealand,  Philippines,  South Africa,  Sweden,  Trinidad and Tobago,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycaemic index
Secondary within-individual variation of glycaemic responses
Secondary glycaemic responses assessed as incremental area under the curve
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