Clinical trial NCT00260858: GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods
Official title: Measuring the Glycaemic Index of Foods: Interlaboratory Study #2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glycemic index
Nutrition
Carbohydrates
Glycemic responses
Methodology
Healthy human subjects
Lead sponsor: Glycaemic Index Testing, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sydney University Glycaemic Index Research Services
name: ILSI Europe
First posted: 2005-12-02
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Diabetes
* Pregnancy or lactation

Primary outcomes:
measure: glycaemic index
Secondary outcomes:
measure: within-individual variation of glycaemic responses
measure: glycaemic responses assessed as incremental area under the curve
Other outcomes:
Locations:
city: Gainsville
country: United States
facility: Abernethy Research
state: Florida
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
city: Melbourne
country: Australia
facility: International Diabetes Institute
state: Victoria
city: Toronto
country: Canada
facility: Glycemic Index Laboratories, Inc.
state: Ontario
city: Beijing
country: China
facility: Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention
state: Beijing
city: Copenhagen
country: Denmark
facility: The Royal Veterinary & Agricultural University
city: Helsinki
country: Finland
facility: National Public Health Institute
city: Kuopio
country: Finland
facility: Foodfiles Oy
city: Nantes
country: France
facility: Biofortis
city: Potsdam-Rehbrucke
country: Germany
facility: German Institute of Human Nutrition
state: Nuthetal
city: Milan
country: Italy
facility: University of Milan
city: Parma
country: Italy
facility: University of Parma
city: Kota Bharu
country: Malaysia
facility: University Sains Malaysia
state: Kelantan
city: Maastricht
country: Netherlands
facility: Nutriscience, BV
city: Dunedin
country: New Zealand
facility: University of Otago
state: Otago
city: Diliman
country: Philippines
facility: University of the Philippines
city: Nelspruit
country: South Africa
facility: GI Foundation of South Africa
state: Mpumalanga
city: Potchefstroom
country: South Africa
facility: Potchefstroom University
state: Potchesfstroom
city: Gothenburg
country: Sweden
facility: Gotheburg University
state: Gotheburg
city: Lund
country: Sweden
facility: Lund University
city: Champs Fleurs
country: Trinidad and Tobago
facility: University of the West Indies
state: Trinidad
city: Reading
country: United Kingdom
facility: Reading Scientific Services, Ltd.
state: Berkshire
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
city: Leatherhead
country: United Kingdom
facility: Leatherhead Food International
state: Surrey
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Janette C Brand-Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolever TM, Brand-Miller JC, Abernethy J, Astrup A, Atkinson F, Axelsen M, Bjorck I, Brighenti F, Brown R, Brynes A, Casiraghi MC, Cazaubiel M, Dahlqvist L, Delport E, Denyer GS, Erba D, Frost G, Granfeldt Y, Hampton S, Hart VA, Hatonen KA, Henry CJ, Hertzler S, Hull S, Jerling J, Johnston KL, Lightowler H, Mann N, Morgan L, Panlasigui LN, Pelkman C, Perry T, Pfeiffer AF, Pieters M, Ramdath DD, Ramsingh RT, Robert SD, Robinson C, Sarkkinen E, Scazzina F, Sison DC, Sloth B, Staniforth J, Tapola N, Valsta LM, Verkooijen I, Weickert MO, Weseler AR, Wilkie P, Zhang J. Measuring the glycemic index of foods: interlaboratory study. Am J Clin Nutr. 2008 Jan;87(1):247S-257S. doi: 10.1093/ajcn/87.1.247S.