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Glycemic Load, Weight Loss and Cardiovascular Disease Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254215
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : November 28, 2006
Meat & Livestock Australia
National Heart Foundation, Australia
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: high protein & low glycemic index diets Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
Study Start Date : March 2002
Study Completion Date : October 2004

Primary Outcome Measures :
  1. weight loss at 12 weeks
  2. Fat loss at 12 weeks
  3. Lean mass change at 12 weeks

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254215

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Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
Sponsors and Collaborators
University of Sydney
Meat & Livestock Australia
National Heart Foundation, Australia
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Principal Investigator: Jennie C Brand-Miller, PhD University of Sydney
Publications of Results:
Layout table for additonal information Identifier: NCT00254215    
Other Study ID Numbers: NHF G02S 0768 - Brand-Miller
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: November 28, 2006
Last Verified: July 2005
Keywords provided by University of Sydney:
glycemic index
glycemic load
high protein diet
blood cholesterol
Additional relevant MeSH terms:
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Body Weight