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Completed

NCT Number: NCT00254215

Glycemic Load, Weight Loss and Cardiovascular Disease Risk

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Sydney

Sydney, New South Wales, 2006, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

high protein & low glycemic index diets

Behavioral

Primary outcomes

  1. weight loss at 12 weeks

  2. Fat loss at 12 weeks

  3. Lean mass change at 12 weeks

Secondary outcomes

  1. Total cholesterol, LDL and HDL cholesterol change at 12 weeks

  2. glucose, insulin & measures of insulin sensitivity change at 12 weeks

  3. TG change at 12 weeks

  4. Leptin change at 12 weeks

  5. CRP change at 12 weeks

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • Meat & Livestock Australia
  • National Heart Foundation, Australia

Registry information

Official study title

The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors

Important dates

Study start
2002
Study completion
2004
First posted
Nov 15, 2005
Registry last updated
Nov 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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