Effect of Betaine Supplementation on Body Composition in Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12614000232639
• Lead Sponsor: Peter M George

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 75

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in body composition on DEXA scan, BMI, and waist circumference <br>[Baseline and six months]

Secondary Outcome Measures

Name	Time	Method
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.[Three and six months];Changes in insulin resistance measured by calculating the CIGMA-HOMA insulin resistance index and plasma haemoglobin A1c a using standard laboratory assay.[Three and six months];Changes in the plasma lipid profile: HDLC LDLC triglycerides and total cholesterol measured by standard laboratory methods.[Three and six months];Changes in vascular risk and inflammation measures, specifically plasma C-reactive protein and IL-6, TNF-alpha measured with ELISA.[Three and six months];Coagulation markers (PAI-1, fibrinogen), adipocines (adiponectin, leptin) and adhesion molecules (VCAM-1, IACAM-1, E-selectin) measured with ELISA.[Three and six months];Change in sitting blood pressure measured via an automated sphygmometer.[Three and six months]