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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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

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

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
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 292 0
New Zealand
State/province [1] 292 0

Funding & Sponsors
Funding source category [1] 1254 0
Name [1] 1254 0
National Heart Foundation
Address [1] 1254 0
Country [1] 1254 0
Primary sponsor type
Government body
Canterbury Health Laboratories
New Zealand
Secondary sponsor category [1] 1113 0
Name [1] 1113 0
Address [1] 1113 0
Country [1] 1113 0

Ethics approval
Ethics application status
Ethics committee name [1] 2592 0
Canterbury Health Laboratories
Ethics committee address [1] 2592 0
Ethics committee country [1] 2592 0
Date submitted for ethics approval [1] 2592 0
Approval date [1] 2592 0
Ethics approval number [1] 2592 0

Brief summary
People with high blood levels of homocysteine are more likely to have heart attacks. Betaine helps keep homocysteine levels down. Many foods (including wheat-based breakfast cereals and some vegetables) are rich in betaine. In addition, betaine (also called “trimethylglycine”) can be purchased as a dietary supplement from health food stores. This research will investigate which approach has the greatest influence on homocysteine levels over a prolonged time period, eating more betaine in the diet or taking betaine in the form of dietary supplements. We hope to learn more about how betaine can be most effectively used to lower homocysteine and decrease the risk of heart attacks.
Trial website
Trial related presentations / publications
Public notes

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
Country 10132 0
New Zealand
Phone 10132 0
+64 3 3641594
Fax 10132 0
Email 10132 0
Contact person for scientific queries
Name 1060 0
Dr Wendy Atkinson
Address 1060 0
Clinical Biochemistry Department
Canterbury Health Laboratories
PO Box 151
Country 1060 0
New Zealand
Phone 1060 0
+64 3 3641594
Fax 1060 0
Email 1060 0

No information has been provided regarding IPD availability
Summary results
No Results