Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000889257
Ethics application status
Approved
Date submitted
9/10/2009
Date registered
12/10/2009
Date last updated
12/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
To investigate the effects of three different meals (different glycemic index (GI) content) on blood pressure, blood vessel function, blood glucose and lipids.
Scientific title
To investigate and compare the acute effects of three different meals on a range of metabolic and vascular parameters in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
GI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type-2 diabetes 251976 0
Cardiovascular Disease 251983 0
Condition category
Condition code
Metabolic and Endocrine 252166 252166 0 0
Diabetes
Cardiovascular 252174 252174 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acute postprandial effects of two meals of different GI content will be tested against a control meal on a range of metabolic and vascular parameters. Participants will be required to consume three different meals, one meal per visit served in random order, with a minimum one week washout between each visit. The two meals will be 1) a low GI meal, containing 14g of protein with a GI index of 45, and 2) moderately-high protein, containing 23g of protein with a GI index of 45.
Intervention code [1] 241386 0
Prevention
Intervention code [2] 241395 0
Lifestyle
Comparator / control treatment
A high GI content meal, containing 15g of protein with a GI index of 76, serves as the control. This meal is randomly allocated to one of the three visits, with a one week washout period seperating the three visits.
Control group
Dose comparison

Outcomes
Primary outcome [1] 253041 0
Glucose measured by blood analysis.
Timepoint [1] 253041 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals up to 2 hours postprandially (20, 40, 60, 90 and 120 minutes).
Primary outcome [2] 253053 0
Insulin measured by blood analysis.
Timepoint [2] 253053 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals up to 2 hours postprandially (20, 40, 60, 90 and 120 minutes).
Primary outcome [3] 253054 0
Triglycerides measured by blood analysis.
Timepoint [3] 253054 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals up to 2 hours postprandially (20, 40, 60, 90 and 120 minutes).
Primary outcome [4] 253055 0
Brachial blood pressure measured using a semiautomated electronic blood pressure monitor.
Timepoint [4] 253055 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals up to 2 hours postprandially (20, 40, 60, 90 and 120 minutes). Multiple readings are to be recorded at each time point.
Primary outcome [5] 253056 0
Central blood pressure measure using pulse wave analysis technique
Timepoint [5] 253056 0
Measured after an overnight fast (10 to 12 hours) and at regular intervals up to 2 hours postprandially (20, 40, 60, 90 and 120 minutes). Multiple readings are to be recorded at each time point.
Secondary outcome [1] 257853 0
adenosine diphosphate (ADP) induced Platelet aggragation
Timepoint [1] 257853 0
Measured after an overnight fast (10 to 12 hours), one and two hours postprandially.

Eligibility
Key inclusion criteria
Males and females aged between 18 and 80 years with no self known history of heart, liver and/or kidney disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals taking medication for hypertension and heart disease. Also, individuals diagnosed with type-2 diabetes will be excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prior to the study commencing an outside investigator, not directly involved with the study, randomised meal order for identification numbers and sealed these in labeled envelopes. Subject screening is performed to ensure participants meet the inclusion/exculsion criteria. After inclusion into the study, participants are given a identification number, which has a previously allocated randomised meal order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Excel was used to randomise meal order for individual identification numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Randomised cross-over design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243857 0
Charities/Societies/Foundations
Name [1] 243857 0
Clifford Craig Medical Research Trust
Country [1] 243857 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Newnham Drive,
Newnham, TAS 7250
Country
Australia
Secondary sponsor category [1] 237206 0
None
Name [1] 237206 0
Address [1] 237206 0
Country [1] 237206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243974 0
Tasmanian Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 243974 0
Ethics committee country [1] 243974 0
Australia
Date submitted for ethics approval [1] 243974 0
Approval date [1] 243974 0
26/04/2009
Ethics approval number [1] 243974 0
H0009855

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30365 0
Address 30365 0
Country 30365 0
Phone 30365 0
Fax 30365 0
Email 30365 0
Contact person for public queries
Name 13612 0
Dr. Kiran Ahuja
Address 13612 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 13612 0
Australia
Phone 13612 0
+61 3 6324 5478
Fax 13612 0
Email 13612 0
[email protected]
Contact person for scientific queries
Name 4540 0
Dr. Kiran Ahuja
Address 4540 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 4540 0
Australia
Phone 4540 0
+61 3 6324 5478
Fax 4540 0
Email 4540 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.