HealthyNCT00260858
GI Interlab 2 Study: Measuring the Glycaemic Index (GI) of Foods
A study testing Test Meal: Reference food (glucose or white bread), Test Meal: Pirate's Booty and Test Meal: Ceaprove wafer in people with Healthy, run by Glycaemic Index Testing, Inc. at 28 sites in 17 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test Meal: Reference food (glucose or white bread), Test Meal: Pirate's Booty and Test Meal: Ceaprove wafer
- How many people
- 280 participants
- Where
- 28 sitesin 17 countries
- Study dates
- Nov 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects
Who cannot join
- Diabetes
- Pregnancy or lactation
Trial locations and contacts
28 sites in 17 countries.
28 sites in 17 countries
United Kingdom5 sites
University of Surrey
Guildford, Surrey, GU5 7XH
Leatherhead Food International
Leatherhead, Surrey, KT22 7RY
Hammersmith Hospital
London, London, W12 0HS
Oxford Brookes University
Oxford, Oxfordshire, OX3 0BP
Reading Scientific Services, Ltd.
Reading, Berkshire
United States3 sites
University of Buffalo
Buffalo, New York, 14214-3000
Ohio State University
Columbus, Ohio, 43210-1295
Abernethy Research
Gainsville, Florida, 32601
Australia2 sites
International Diabetes Institute
Melbourne, Victoria, 3162
University of Sydney
Sydney, New South Wales
Finland2 sites
National Public Health Institute
Helsinki, Helsinki, FIN-00300
Foodfiles Oy
Kuopio, Kuopio, FI-70210
Italy2 sites
University of Milan
Milan, Milan, 20133
University of Parma
Parma, Parma, 43100
South Africa2 sites
GI Foundation of South Africa
Mbombela, Mpumalanga, 1200
Potchefstroom University
Potchefstroom, Potchesfstroom, 2520
Sweden2 sites
Gotheburg University
Gothenburg, Gotheburg, 413 90
Lund University
Lund, Lund, 222 41
China1 site
Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention
Beijing, Beijing Municipality, 100050
Germany1 site
German Institute of Human Nutrition
Potsdam-Rehbrucke, Nuthetal, D-14558
Trinidad and Tobago1 site
University of the West Indies
Champs Fleurs, Trinidad
About this study
Official title: Measuring the Glycaemic Index of Foods: Interlaboratory Study #2
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Test Meal: Reference food (glucose or white bread), Test Meal: Pirate's Booty, Test Meal: Ceaprove wafer, Test Meal: Stretch Island Strawberry Fruit Leather
- Keywords
- Glycemic index, Nutrition, Carbohydrates, Glycemic responses, Methodology, Healthy human subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Meal: Reference food (glucose or white bread)Drug
Test Meal: Pirate's BootyDrug
Test Meal: Ceaprove waferDrug
Test Meal: Stretch Island Strawberry Fruit LeatherDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
glycaemic index
Secondary outcomes (2)
within-individual variation of glycaemic responses
glycaemic responses assessed as incremental area under the curve
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startNov 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Glycaemic Index Testing, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney, ILSI Europe
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, University of TorontoJanette C Brand-Miller, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260858
- Sponsor's protocol ID
- GIL5047
- Status last verified
- Jun 2006
- First submitted
- 30 Nov 2005
- Last updated
- 9 Jun 2006
- Results posted
- No
Publications
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.
PubMed 18175765
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Glycaemic Index of Foods: Interlaboratory Study #2
- ClinicalTrials.gov ID
- NCT00260858
- Acronym / sponsor ID
- GIL5047
- Conditions
- Healthy
- Keywords
- Glycemic index, Nutrition, Carbohydrates, Glycemic responses, Methodology, Healthy human subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- Glycaemic Index Testing, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Sydney, ILSI Europe
- Study start
- Nov 2005
- Study completion
- Apr 2006
- First posted
- 2 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects
Key exclusion criteria (2 listed)
- Diabetes
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | – |
Primary outcome
glycaemic index
2 secondary outcomes
within-individual variation of glycaemic responses
glycaemic responses assessed as incremental area under the curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2006.
- Derived from this study: PubMed 18175765Wolever 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas MS Wolever, MD, PhD principal investigator
University of Toronto
Janette C Brand-Miller, PhD principal investigator
University of Sydney
28 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Meal: Reference food (glucose or white bread), Test Meal: Pirate's Booty and Test Meal: Ceaprove wafer in people with Healthy, run by Glycaemic Index Testing, Inc. at 28 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom, United States, Australia, Finland, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycaemic index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2006.