Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000604606
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 extended ad libitum consumption study
Scientific title
A cross-over trial of the effect of ad libitum supplementation of chickpeas in the diet on nutrient intake, physiologic or metabolic parameters, compared to an ad libitum diet only for the reduction in 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 733 0
Glucose intolerance 734 0
Condition category
Condition code
Cardiovascular 811 811 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sequential cross-over trial comparing the effects of a stated minimum amount of chickpeas per week (four 300g cans) with an unrestricted (usual) diet of the subject's choosing. Chickpea diet period was 12 weeks duration.
Intervention code [1] 694 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1039 0
Serum lipid and lipoprotein levels
Timepoint [1] 1039 0
Measured at the end of 4 weeks of observed usual diet, at the end of 12 weeks of the ad libitum chickpea diet, and after a further 4 weeks on the usual diet (weeks 4, 16 and 20)
Primary outcome [2] 1040 0
Plasma glucose levels
Timepoint [2] 1040 0
Measured at the end of 4 weeks of observed usual diet, at the end of 12 weeks of the ad libitum chickpea diet, and after a further 4 weeks on the usual diet (weeks 4, 16 and 20)
Primary outcome [3] 1041 0
Serum insulin levels
Timepoint [3] 1041 0
Measured at the end of 4 weeks of observed usual diet, at the end of 12 weeks of the ad libitum chickpea diet, and after a further 4 weeks on the usual diet (weeks 4, 16 and 20)
Secondary outcome [1] 1935 0
Plasma homocystine levels
Timepoint [1] 1935 0
Results were measured at weeks 4, 16 and 20
Secondary outcome [2] 1936 0
Blood glutathione peroxidase levels
Timepoint [2] 1936 0
Results were measured at weeks 4, 16 and 20
Secondary outcome [3] 1937 0
Serum leptin levels
Timepoint [3] 1937 0
Results were measured at weeks 4, 16 and 20
Secondary outcome [4] 1938 0
Antioxidant status and haematological parameters
Timepoint [4] 1938 0
Results were measured at weeks 4, 16 and 20
Secondary outcome [5] 1939 0
Perceived degrees of satiety, perceived degrees of bowel health and function.
Timepoint [5] 1939 0
Results were measured at weeks 4, 16 and 20

Eligibility
Key inclusion criteria
Middle-aged, healthy, recruited by newspaper advertisement who were willing to eat a chickpea supplemented diet for a 12 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
Prevention
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
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
1/09/2004
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] 897 0
University
Name [1] 897 0
University of Tasmania
Country [1] 897 0
Australia
Funding source category [2] 898 0
Government body
Name [2] 898 0
Grains Research Development Corporation
Country [2] 898 0
Australia
Primary sponsor type
University
Name
School of Human Life Sciences, University of Tasmania
Address
Country
Australia
Secondary sponsor category [1] 759 0
None
Name [1] 759 0
None
Address [1] 759 0
Country [1] 759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2181 0
HUMAN RESEARCH ETHICS COMMITTEE (TASMANIA) NETWORK: Medical
Ethics committee address [1] 2181 0
Ethics committee country [1] 2181 0
Australia
Date submitted for ethics approval [1] 2181 0
Approval date [1] 2181 0
Ethics approval number [1] 2181 0

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

Contacts
Principal investigator
Name 35576 0
Address 35576 0
Country 35576 0
Phone 35576 0
Fax 35576 0
Email 35576 0
Contact person for public queries
Name 9883 0
Ms Jane Pittaway
Address 9883 0
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 9883 0
Australia
Phone 9883 0
+61 3 63245495
Fax 9883 0
+61 3 63243658
Email 9883 0
[email protected]
Contact person for scientific queries
Name 811 0
Professor Madeleine Ball
Address 811 0
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 811 0
Australia
Phone 811 0
+61 3 63245480
Fax 811 0
+61 3 63243658
Email 811 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.