Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000419066
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
25/05/2010
Date last updated
25/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishment of a Routine Glycemic Index testing capability using healthy volunteers.
Scientific title
Establishment of a Routine Glycemic Index testing capability by administering a reference food to healthy volunteers.
Secondary ID [1] 251711 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Determining Glycemic Index of foods using healthy subjects 257332 0
Condition category
Condition code
Other 257475 257475 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Glycemic Index is a system of ranking carbohydrate-containing foods according to their immediate effect on blood sugar levels.

Using Australian Standard 4694-2007, The Glycemic index of of foods will be determined.

The test protocol itself is standardised, straightforward and well-defined. Briefly, a set number of participants (minimum of 10) consume the test or reference food (containing 50 g of available carbohydrate). Immediately before, and at designated intervals after food consumption, capillary blood (a few microlitres) is collected by fingerprick and its glucose content measured. Integrated areas under the glycemic response curves are then derived. To calculate the Gycemic Index of the test food, its Integrated Area Under Curve is indexed against that of the average Integrated Area Under Curve for the reference food (mean of three separate tests).

Each participant will consume one test food or one glucose reference item on a single testing day.

The duration between tests will be a minimum of 3 days.

The overall duration of the testing in each participant will be 5 X 3 hour sessions over a period of 5 weeks, with testing occurring once per week.
Intervention code [1] 256438 0
Other interventions
Comparator / control treatment
To calculate the Glycemic Index of the test food, its Integrated Area Under Curve is indexed against that of the average Integrated Area Under Curve for the glucose reference (mean of three separate tests).
Control group
Active

Outcomes
Primary outcome [1] 258385 0
Determine the Glycemic Index value of individual foods
Timepoint [1] 258385 0
Blood samples (via finger prick) will be taken at 0, 15, 30, 45, 60, 90 and 120 minutes after the first mouthful of test or reference food is consumed.

Blood glucose is quantified using spectrophotometry or electrochemical detection on coupled enzyme systems
Secondary outcome [1] 264122 0
None
Timepoint [1] 264122 0
None

Eligibility
Key inclusion criteria
Male or female, aged 18-65 years with a normal fasting blood glucose concentration of 3.5 – 5.5 mmol/L.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of diabetes, sufferers of bleeding disorders, known food allergy, hypersensitivity or intolerance to the study foods, taking medications known to influence glucose tolerance (oral contraceptives are excepted), persons considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol, participation in another research study within 30 days preceding the start of this study and history or presence of gastrointestinal, renal or hepatic disease of any cause.

Study design
Purpose of the study
Educational / counselling / training
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256934 0
Government body
Name [1] 256934 0
Commonwealth Scientific and Industrial Research Organisation
Country [1] 256934 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation
Address
Commonwealth Scientific and Industrial Research Organisation, Food and Nutritional Sciences, Gate 13 Kintore Avenue, ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 256200 0
None
Name [1] 256200 0
Address [1] 256200 0
Country [1] 256200 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The Glycemic Index is a system of ranking carbohydrate-containing foods according to their immediate effect on blood sugar levels. A pool of up to 20 participants will initially need to be formed and maintained (ie have up-to-date glycemic response data for the reference food) for this purpose. If required due to demand for testing, the pool of participants will be increased further. The test protocol itself is standardised, straightforward and well-defined. Briefly, a set number of participants (minimum of 10) consume the test or reference food (containing 50 g of available carbohydrate). Immediately before, and at designated intervals after food consumption, capillary blood (a few microlitres) is collected by fingerprick and its glucose content measured. Integrated areas under the glycemic response curves are then derived. To calculate the Glycemic Index of the test food, its Integrated Area Under Curve is indexed against that of the average Integrated Area Under Curve for the reference food (mean of three separate tests).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31136 0
Address 31136 0
Country 31136 0
Phone 31136 0
Fax 31136 0
Email 31136 0
Contact person for public queries
Name 14383 0
Dr Tony Bird
Address 14383 0
Commonwealth Scientific and Industrial Research Organisation, Food and Nutritional Sciences, Gate 13 Kintore Avenue, ADELAIDE SA 5000
Country 14383 0
Australia
Phone 14383 0
+61 8 8303 8800
Fax 14383 0
Email 14383 0
Tony.Bird@csiro.au
Contact person for scientific queries
Name 5311 0
Dr Tony Bird
Address 5311 0
Commonwealth Scientific and Industrial Research Organisation, Food and Nutritional Sciences, Gate 13 Kintore Avenue, ADELAIDE SA 5000
Country 5311 0
Australia
Phone 5311 0
+61 8 8303 8800
Fax 5311 0
Email 5311 0
Tony.Bird@csiro.au

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

Documents added manually
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Documents added automatically
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