Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000434695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Glycine Betaine on fasting and Post methionine load homocysteine concentrations in healthy volunteers.
Scientific title
The effect of 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:
N/A 545 0
Healthy Volunteers 546 0
Condition category
Condition code
Other 623 623 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-week intervention study investigating the effect of dietary manipulation versus dietary supplementation of glycine betaine on fasting and post-methionine load homocysteine concentrations.
Intervention code [1] 473 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 729 0
Homocysteine concentrations
Timepoint [1] 729 0
At 0, 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours post dose.
Secondary outcome [1] 1494 0
Plasma glycine betaine, choline, methionine, and urine glycine betaine and choline concentrations.
Timepoint [1] 1494 0
At 0, 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours post dose.

Eligibility
Key inclusion criteria
Healthy volunteers with no previous history of vascular disease and no illness requiring medication, normal haemoglobin concentration.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The presence of vitamin B12, vitamin B6 or folate deficiency, and/or 677C->T polymorphism 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)
stratified, latin square design
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
11/08/2006
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] 203 0
New Zealand
State/province [1] 203 0

Funding & Sponsors
Funding source category [1] 681 0
Charities/Societies/Foundations
Name [1] 681 0
National Heart Foundation
Country [1] 681 0
New Zealand
Primary sponsor type
Government body
Name
Canterbury health laboratories
Address
Country
New Zealand
Secondary sponsor category [1] 570 0
None
Name [1] 570 0
n/a
Address [1] 570 0
Country [1] 570 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36295 0
Address 36295 0
Country 36295 0
Phone 36295 0
Fax 36295 0
Email 36295 0
Contact person for public queries
Name 9662 0
Wendy Atkinson
Address 9662 0
Specialist Biochemistry
Canterbury Health Laboratories
PO Box 151
Christchurch 8001
Country 9662 0
New Zealand
Phone 9662 0
+64 3 3640122
Fax 9662 0
Email 9662 0
[email protected]
Contact person for scientific queries
Name 590 0
Wendy Atkinson
Address 590 0
Specialist Biochemistry
Canterbury Health Laboratories
PO Box 151
Christchurch 8001
Country 590 0
New Zealand
Phone 590 0
+64 3 3640122
Fax 590 0
Email 590 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.