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

Sponsor

Glycaemic Index Testing, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00260858

Collaborator

Sydney University Glycaemic Index Research Services (Other), ILSI Europe (Other)

280

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Test Meal: Reference food (glucose or white bread) Drug: Test Meal: Pirate's Booty Drug: Test Meal: Ceaprove wafer Drug: Test Meal: Stretch Island Strawberry Fruit Leather	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Measuring the Glycaemic Index of Foods: Interlaboratory Study #2

Study Start Date :

Nov 1, 2005

Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

glycaemic index []

Secondary Outcome Measures

within-individual variation of glycaemic responses []
glycaemic responses assessed as incremental area under the curve []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male or female subjects

Exclusion Criteria:

Diabetes
Pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abernethy Research	Gainsville	Florida	United States	32601
2	University of Buffalo	Buffalo	New York	United States	14214-3000
3	Ohio State University	Columbus	Ohio	United States	43210-1295
4	University of Sydney	Sydney	New South Wales	Australia
5	International Diabetes Institute	Melbourne	Victoria	Australia	3162
6	Glycemic Index Laboratories, Inc.	Toronto	Ontario	Canada	M5C 2X3
7	Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention	Beijing	Beijing	China	100050
8	The Royal Veterinary & Agricultural University	Copenhagen		Denmark
9	National Public Health Institute	Helsinki		Finland	FIN-00300
10	Foodfiles Oy	Kuopio		Finland	FI-70210
11	Biofortis	Nantes		France	44200
12	German Institute of Human Nutrition	Potsdam-Rehbrucke	Nuthetal	Germany	D-14558
13	University of Milan	Milan		Italy	20133
14	University of Parma	Parma		Italy	43100
15	University Sains Malaysia	Kota Bharu	Kelantan	Malaysia
16	Nutriscience, BV	Maastricht		Netherlands	6200
17	University of Otago	Dunedin	Otago	New Zealand
18	University of the Philippines	Diliman		Philippines
19	GI Foundation of South Africa	Nelspruit	Mpumalanga	South Africa	1200
20	Potchefstroom University	Potchefstroom	Potchesfstroom	South Africa	2520
21	Gotheburg University	Gothenburg	Gotheburg	Sweden	413 90
22	Lund University	Lund		Sweden	222 41
23	University of the West Indies	Champs Fleurs	Trinidad	Trinidad and Tobago
24	Reading Scientific Services, Ltd.	Reading	Berkshire	United Kingdom
25	Oxford Brookes University	Oxford	Oxfordshire	United Kingdom	OX3 0BP
26	University of Surrey	Guildford	Surrey	United Kingdom	GU5 7XH
27	Leatherhead Food International	Leatherhead	Surrey	United Kingdom	KT22 7RY
28	Hammersmith Hospital	London		United Kingdom	W12 0HS