Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000605695
Ethics application status
Approved
Date submitted
4/10/2005
Date registered
6/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Launceston chickpea study
Scientific title
A randomised crossover trial of the effect of dietary chickpea on plasma lipids and measures of glucose tolerance in the reduction of cardiovascular disease risk factors
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk 735 0
Glucose intolerance 736 0
Condition category
Condition code
Cardiovascular 812 812 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised cross-over trial comparing the effects of consumption of 140g of chickpeas (Edgell canned chickpeas) plus an ad libitum quantity of bread and biscuits containing 30% chickpea flour versus a similar diet with wheat flour replacing chickpea flour and wheat fibre replacing the raw chickpeas. Duration 5 weeks on each diet with an 8 week wash-out period between diets.
Intervention code [1] 695 0
Lifestyle
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1042 0
Serum lipid and lipoprotein levels
Timepoint [1] 1042 0
Measured at the start and end of each 5 week dietary period
Primary outcome [2] 1043 0
Plasma glucose levels
Timepoint [2] 1043 0
Measured at the start and end of each 5 week dietary period
Primary outcome [3] 1044 0
Serum insulin levels
Timepoint [3] 1044 0
Measured at the start and end of each 5 week dietary period
Secondary outcome [1] 1940 0
4-day weighed food diary assessment of dietary intake during final week of each diet period.
Timepoint [1] 1940 0

Eligibility
Key inclusion criteria
Middle-aged, healthy,recruited by newspaper advertisement who were willing to eat a chickpea supplemented diet for a 5 week period.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those on lipid-lowering or anti-diabetic medication; intolerant to chickpea or wheat.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation following recruitment from predetermined list, not concealed from research officer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 899 0
University
Name [1] 899 0
University of Tasmania
Country [1] 899 0
Australia
Funding source category [2] 900 0
Government body
Name [2] 900 0
Grains Research Development Corporation
Country [2] 900 0
Australia
Primary sponsor type
University
Name
School of Human Life Sciences, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 760 0
None
Name [1] 760 0
None
Address [1] 760 0
Country [1] 760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2182 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK: Medical
Ethics committee address [1] 2182 0
Ethics committee country [1] 2182 0
Australia
Date submitted for ethics approval [1] 2182 0
Approval date [1] 2182 0
Ethics approval number [1] 2182 0

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

Contacts
Principal investigator
Name 35241 0
Address 35241 0
Country 35241 0
Phone 35241 0
Fax 35241 0
Email 35241 0
Contact person for public queries
Name 9884 0
Ms Jane Pittaway
Address 9884 0
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 9884 0
Australia
Phone 9884 0
+61 3 63245495
Fax 9884 0
+61 3 63243658
Email 9884 0
[email protected]
Contact person for scientific queries
Name 812 0
Professor Madeleine Ball
Address 812 0
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 812 0
Australia
Phone 812 0
+61 3 63245480
Fax 812 0
+61 3 63243658
Email 812 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.