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Effect of Betaine Supplementation on Body Composition in Metabolic Syndrome

A randomised controlled trial evaluating the effects of Betaine Supplementation on Body Composition in Adult Males with Metabolic Syndrome

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000232639
Acronym
BBC
Enrollment
75
Registered
2014-03-05
Start date
2014-06-18
Completion date
2016-03-17
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to determine if dietary betaine supplementation has a favourable effect on body composition and indices of lipid and glucose metabolism.

Interventions

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 sequence

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.

Sponsors

Peter M George
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Males with metabolic syndrome and waist circumference greater than 90 cm, hypertension and dyslipidaemia

Exclusion criteria

Fibrate therapy, chronic renal failure, diabetes, other major illness

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026