Glycemic Load, Weight Loss and Cardiovascular Disease Risk

Phase 1

Completed

• Conditions: Overweight; Obesity

• Registration Number: NCT00254215
• Lead Sponsor: University of Sydney

Brief Summary

To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.

Detailed Description

Conventional low fat diets produce modest wegiht loss at best and the results are not well maintained. More recently there has been interest in low glycemic index and high protien diets wiht some evidence that these produce better fat loss and improvement in cardiovascular risk factors. This trial aims to evaluate these different approaches and compare the outcomes over 12 weeks. Major outcomes are weigth loss, body composition change, blood lipids change, measures of glucose homeostasis, insulin resistance, leptin and CRP.

Study Timeline

• Study Start: 2002-03
• Study Completion: 2004-10
• Status Verified: 2005-07
• Study First Submitted: 2005-11-13
• Study First Submitted QC: 2005-11-13
• Study First Posted: 2005-11-15
• Last Update Submitted: 2006-11-27
• Last Update Posted: 2006-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18-40 years of age BMI >=25 stable weight for 3 months non-vegetarian good understanding of English

Exclusion Criteria

medications other than the contraceptive pill weight >150kg (weight limit of DEXA machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
weight loss at 12 weeks
Fat loss at 12 weeks
Lean mass change at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Total cholesterol, LDL and HDL cholesterol change at 12 weeks
glucose, insulin & measures of insulin sensitivity change at 12 weeks
TG change at 12 weeks
Leptin change at 12 weeks
CRP change at 12 weeks

Trial Locations

Locations (1)

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia