Short term effects of supplementing the amino acid, leucine during weight loss on improvements in body composition and insulin sensitivity in individuals at risk of the metabolic syndrome.

Not Applicable

Completed

• Conditions: obesity; Insulin resistance; metabolic syndrome; cardio vascular; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001528448
• Lead Sponsor: A/Prof. Mario Soares

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Adult Australian men and women with abdominal obesity and at least one other criteria for MetS as judged by recent consensus guidelines (Alberti et al, 2009), aged 20- 65 years, of European origin, Not on calcium or vitamin supplements. Medications like lipid lowering therapy and hypertension will be quantified and monitored.

Exclusion Criteria

any history of MI, stroke, T1DM or weight loss in previous 6 months,on medication that affects body composition, energy expenditure or food intake will be excluded

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body composition by Dual Energy X-ray Absorptiometry (DEXA, Prodigy, Lunar)[ 8 weeks post commencement of supplementation ];insulin sensitivity from fasting blood samples and measures of glucose, insulin and triglycerides to calculate surrogate markers like HOMA-IR, McAuleys' index, ISI. [8 weeks post commencement of supplementation ]

Secondary Outcome Measures

Name	Time	Method
substrate oxidation by indirect calorimetry [8 weeks post commencement of supplementation];Liver function tests from fasting blood samples and measures of Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase and total and conjugated bilirubin concentrations, [8 weeks post commencement of supplementation];vitamin D status from Serum 25 hydroxycholecalciferol (25OHD) levels[8 weeks post commencement of supplementation]