Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000501549
Ethics application status
Approved
Date submitted
24/11/2006
Date registered
5/12/2006
Date last updated
5/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of proline betaine in orange juice on homocysteine concentrations in healthy male Caucasians
Scientific title
A study to compare orange juice versus supplementation with proline betaine on homocysteine concentrations in healthy male Caucasians
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers 1477 0
Condition category
Condition code
Other 1573 1573 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive a single dose of two treatments (a, b) in random order. Treatment (a) is 750 mL orange juice, treatment (b) is proline betaine (0.532g dissolved in 750 mL apple juice). The treatment duration will be one day (24 hours) each week for three consecutive weeks with a wash-out period of 6 days between treatments.
Intervention code [1] 1465 0
Treatment: Other
Comparator / control treatment
Subjects will receive a single dose of treatments (c) in random order. Treatment (c) is a placebo control of 750 mL apple juice only. The treatment duration will be one day (24 hours) each week for three consecutive weeks with a wash-out period of 6 days between treatments.
Control group
Placebo

Outcomes
Primary outcome [1] 2174 0
Plasma homocysteine concentrations
Timepoint [1] 2174 0
At baseline and 20, 40, 60 90, 120, 180, 240, 300, 360 minutes and 24 hours post-treatment.
Secondary outcome [1] 3788 0
Plasma glycine betaine and proline betaine concentrations
Timepoint [1] 3788 0
At baseline and 20, 40, 60 90, 120, 180, 240, 300, 360 minutes and 24 hours post-treatment.
Secondary outcome [2] 3789 0
Urine glycine betaine and proline betaine concentrations
Timepoint [2] 3789 0
At baseline and 20, 40, 60 90, 120, 180, 240, 300, 360 and 24 hours post-treatment.

Eligibility
Key inclusion criteria
Healthy Caucasian volunteers, with a normal fasting plasma homocysteine concentration.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Vitamin B12 or folate deficiency, chronic or acute illness requiring prescription medication, current or previous history of vascular or renal disease, and smokers.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated using simple randomisation generated by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 433 0
New Zealand
State/province [1] 433 0

Funding & Sponsors
Funding source category [1] 1715 0
Charities/Societies/Foundations
Name [1] 1715 0
National Heart Foundation
Country [1] 1715 0
New Zealand
Funding source category [2] 1716 0
University
Name [2] 1716 0
Christchurch School of Medicine summer studentship programme
Country [2] 1716 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury Health Laboratories
Address
Country
New Zealand
Secondary sponsor category [1] 1515 0
University
Name [1] 1515 0
Christchurch School of Medicine
Address [1] 1515 0
Country [1] 1515 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3174 0
Canterbury Health Laboratories
Ethics committee address [1] 3174 0
Ethics committee country [1] 3174 0
New Zealand
Date submitted for ethics approval [1] 3174 0
Approval date [1] 3174 0
25/10/2006
Ethics approval number [1] 3174 0
URA/06/02/002
Ethics committee name [2] 3175 0
Christchurch Clinical Studies Trust
Ethics committee address [2] 3175 0
Ethics committee country [2] 3175 0
New Zealand
Date submitted for ethics approval [2] 3175 0
Approval date [2] 3175 0
25/10/2006
Ethics approval number [2] 3175 0
URA/06/02/002

Summary
Brief summary
People with high blood levels of homocysteine have an increased risk of heart disease and stroke. A previous study by our group has shown that a molecule called 'proline betaine' increased plasma homocysteine levels in rats. Proline betaine is found in the diet with particularly high levels citrus fruits and alfalfa sprouts. This research will investigate whether drinking orange juice raises homocysteine levels healthy male volunteers and if this is a result of proline betaine content. We hope to learn more about how proline betaine influences homocysteine metabolism and whether it has a role in vascular disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27399 0
Address 27399 0
Country 27399 0
Phone 27399 0
Fax 27399 0
Email 27399 0
Contact person for public queries
Name 10654 0
Dr Wendy Atkinson
Address 10654 0
Clinical Biochemistry Department
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 10654 0
New Zealand
Phone 10654 0
+64 3 3641594
Fax 10654 0
Email 10654 0
[email protected]
Contact person for scientific queries
Name 1582 0
Dr Wendy Atkinson
Address 1582 0
Clinical Biochemistry Department
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 1582 0
New Zealand
Phone 1582 0
+64 3 3641594
Fax 1582 0
Email 1582 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.