None listed
Conditions
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 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
Study design
Eligibility
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