Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000232639
Ethics application status
Approved
Date submitted
17/06/2013
Date registered
5/03/2014
Date last updated
29/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Betaine Supplementation on Body Composition in Metabolic Syndrome
Scientific title
A randomised controlled trial evaluating the effects of Betaine Supplementation on Body Composition in Adult Males with Metabolic Syndrome
Secondary ID [1] 282686 0
Nil
Universal Trial Number (UTN)
U1111-1137-2894
Trial acronym
BBC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 289399 0
Condition category
Condition code
Metabolic and Endocrine 289722 289722 0 0
Diabetes
Diet and Nutrition 289723 289723 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated, with equal probability to receive supplemental betaine; either 0.5 g or 2.5 g, or placebo once daily for 6 months. Active treatment sachets will contain 5 g of powder; either 2.5g betaine and 2.5 g water-soluble placebo maltodextrin or 0.5g betaine with 4.5 g water-soluble placebo maltodextrin. Participants will consume one sachet of treatment by dissolving the contents into a beverage of 200 ml once daily for 6 months.

Randomization into 1 of 3 sequences will be performed in permutated block sizes from a computer-generated randomization list. Study treatments will be dispensed in identical numbered packages of sachets with the lowest available number allocated to each sequential participant.

Participants will be contacted by telephone weekly for the first month of study, and thereafter participants will be contacted at fortnightly intervals to improve adherence to study medication. Compliance to treatment will be determined by sachet count.
Intervention code [1] 287346 0
Prevention
Comparator / control treatment
Matching placebo (water-soluble maltodextrin powder sachet (5g) dissolved in beverage) daily for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 289814 0
Change in body composition on DEXA scan, BMI, and waist circumference
Timepoint [1] 289814 0
Baseline and six months
Secondary outcome [1] 306891 0
Changes in betaine metabolism, specifically: plasma and urine betaine and dimethylglycine, plasma choline and Homocysteine, and Post-methionine load plasma homocysteine, betaine and dimethylglycine via the post-methionine load test.
Timepoint [1] 306891 0
Three and six months
Secondary outcome [2] 306981 0
Changes in insulin resistance measured by calculating the CIGMA-HOMA insulin resistance index and plasma haemoglobin A1c a using standard laboratory assay.
Timepoint [2] 306981 0
Three and six months
Secondary outcome [3] 306982 0
Changes in the plasma lipid profile: HDLC LDLC triglycerides and total cholesterol measured by standard laboratory methods.
Timepoint [3] 306982 0
Three and six months
Secondary outcome [4] 306983 0
Changes in vascular risk and inflammation measures, specifically plasma C-reactive protein and IL-6, TNF-alpha measured with ELISA.
Timepoint [4] 306983 0
Three and six months
Secondary outcome [5] 306984 0
Coagulation markers (PAI-1, fibrinogen), adipocines (adiponectin, leptin) and adhesion molecules (VCAM-1, IACAM-1, E-selectin) measured with ELISA.
Timepoint [5] 306984 0
Three and six months
Secondary outcome [6] 306985 0
Change in sitting blood pressure measured via an automated sphygmometer.
Timepoint [6] 306985 0
Three and six months

Eligibility
Key inclusion criteria
Males with metabolic syndrome and waist circumference greater than 90 cm, hypertension and dyslipidaemia
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Fibrate therapy, chronic renal failure, diabetes, other major illness

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)
Treatment allocation is concealed by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANOVA.

In pigs the changes in body composition are >5%. The coefficient of variation in DEXA estimates of body fat % is < 3%, and the intra-individual coefficient of variation in % body fat has been reported as 10%, although this is probably an overestimate since the method used was bioelectrical impedance which is confounded by variations in hydration, and the actual value is more likely to be in the 8-10% range. The proposed recruitment of 25 subjects per group would have sufficient power to detect a significant difference between active treatment and placebo if the intra-individual coefficient of variation is <8%.

The recruitment of 25 subjects per group will provide sufficient power for conclusive and publishable results on the biochemical risk-factor secondary endpoints. Based on our and others previous experience, the plasma betaine concentrations will be raised by 20 to 50 µmol/L by the treatments, detectable with n < 6. The expected change in fasting homocysteine, and the post-methionine load rise in homocysteine, will be readily detectable; the intra-individual variation in plasma homocysteine is 8% and we expect changes >12%. The non-HDL cholesterol will be of particular interest, based on cross-sectional studies the increase in plasma betaine was associated with a 0.15 to 0.4 mmol/L decrease in plasma non-HDL cholesterol, and if this response is realised in this study then 25 subjects per group is sufficient. The effects on changes in measures of insulin resistance, inflammation and coagulation markers will be novel data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/03/2014
Actual
18/06/2014
Date of last participant enrolment
Anticipated
25/08/2014
Actual
17/03/2016
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 5147 0
New Zealand
State/province [1] 5147 0
Canterbury

Funding & Sponsors
Funding source category [1] 287458 0
Commercial sector/Industry
Name [1] 287458 0
Dupont
Country [1] 287458 0
Finland
Primary sponsor type
Individual
Name
Peter M George
Address
Canterbury Health Laboratories
PO Box 151
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 286202 0
None
Name [1] 286202 0
Address [1] 286202 0
Country [1] 286202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289433 0
Southern Region Ethics Committee
Ethics committee address [1] 289433 0
Ethics committee country [1] 289433 0
New Zealand
Date submitted for ethics approval [1] 289433 0
10/12/2012
Approval date [1] 289433 0
14/01/2013
Ethics approval number [1] 289433 0
12/STH/71

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

Contacts
Principal investigator
Name 40826 0
Prof Peter M GEORGE
Address 40826 0
Canterbury Health Laboratories
PO Box 151
Christchurch 8140
Country 40826 0
New Zealand
Phone 40826 0
+64 3 3640325
Fax 40826 0
Email 40826 0
[email protected]
Contact person for public queries
Name 40827 0
Peter M GEORGE
Address 40827 0
Canterbury Health Laboratories
PO Box 151
Christchurch 8140
Country 40827 0
New Zealand
Phone 40827 0
+64 3 3640325
Fax 40827 0
Email 40827 0
[email protected]
Contact person for scientific queries
Name 40828 0
Peter M GEORGE
Address 40828 0
Canterbury Health Laboratories
PO Box 151
Christchurch 8140
Country 40828 0
New Zealand
Phone 40828 0
+64 3 3640325
Fax 40828 0
Email 40828 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.