Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000104550
Ethics application status
Approved
Date submitted
17/03/2006
Date registered
20/03/2006
Date last updated
20/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic dietary modification versus supplementation with glycine betaine, on fasting and post-methionine load homocysteine concentrations in healthy volunteers.
Scientific title
A study to compare dietary modification versus supplementation with glycine betaine, on fasting and post-methionine load homocysteine concentrations in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers 1068 0
Condition category
Condition code
Diet and Nutrition 1149 1149 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will receive 2 treatments (a or b) in random order. Treatment a is a diet rich in glycine betaine (approximately 1500mg per day). The treatment duration will be two weeks, followed by a one week wash out period, and then a further two weeks on the alternative treatment.
Intervention code [1] 943 0
Treatment: Other
Comparator / control treatment
Treatment b is a glycine betaine supplementation regime (3x 500mg tablets each day).
Control group
Active

Outcomes
Primary outcome [1] 1545 0
Homocysteine concentrations
Timepoint [1] 1545 0
At 1, 3, 7, 10, 14, 16 and 20 days post-treatment
Secondary outcome [1] 2790 0
Plasma glycine betaine, choline, methionine, and urine glycine betaine and choline concentrations.
Timepoint [1] 2790 0
At 1, 3, 7, 10, 14, 16 and 20 days post-treatment.
Secondary outcome [2] 2791 0
For each treatment period, duplicate food samples will be also be assayed for glycine betaine and choline measurement to confirm the amount ingested.
Timepoint [2] 2791 0

Eligibility
Key inclusion criteria
Healthy volunteers with no previous history of vascular disease and no illness requiring medication, normal homocysteine concentration.
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of vitamin B12, vitamin B6 or folate deficiency, and/or 677->T polymorphisms in the methylene reductase gene.

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
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
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] 292 0
New Zealand
State/province [1] 292 0

Funding & Sponsors
Funding source category [1] 1254 0
Charities/Societies/Foundations
Name [1] 1254 0
National Heart Foundation
Country [1] 1254 0
Primary sponsor type
Government body
Name
Canterbury Health Laboratories
Address
Country
New Zealand
Secondary sponsor category [1] 1113 0
None
Name [1] 1113 0
N/A
Address [1] 1113 0
Country [1] 1113 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2592 0
Canterbury Health Laboratories
Ethics committee address [1] 2592 0
Ethics committee country [1] 2592 0
Australia
Date submitted for ethics approval [1] 2592 0
Approval date [1] 2592 0
21/02/2006
Ethics approval number [1] 2592 0
URA/06/02/002

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

Contacts
Principal investigator
Name 35226 0
Address 35226 0
Country 35226 0
Phone 35226 0
Fax 35226 0
Email 35226 0
Contact person for public queries
Name 10132 0
Dr Wendy Atkinson
Address 10132 0
Clinical Biochemistry Department
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 10132 0
New Zealand
Phone 10132 0
+64 3 3641594
Fax 10132 0
Email 10132 0
[email protected]
Contact person for scientific queries
Name 1060 0
Dr Wendy Atkinson
Address 1060 0
Clinical Biochemistry Department
Canterbury Health Laboratories
PO Box 151
Christchurch
Country 1060 0
New Zealand
Phone 1060 0
+64 3 3641594
Fax 1060 0
Email 1060 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.