Glycemic Load, Weight Loss and Cardiovascular Disease Risk

This study has been completed.
Sponsor:
Collaborators:
Meat & Livestock Australia
National Heart Foundation, Australia
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00254215
First received: November 13, 2005
Last updated: November 27, 2006
Last verified: July 2005
  Purpose

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 Intervention Phase
Overweight
Obesity
Behavioral: high protein & low glycemic index diets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • weight loss at 12 weeks
  • Fat loss at 12 weeks
  • Lean mass change at 12 weeks

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 120
Study Start Date: March 2002
Estimated Study Completion Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00254215

Locations
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
Investigators
Principal Investigator: Jennie C Brand-Miller, PhD University of Sydney
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00254215     History of Changes
Other Study ID Numbers: NHF G02S 0768 - Brand-Miller
Study First Received: November 13, 2005
Last Updated: November 27, 2006
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Sydney:
overweight
obesity
glycemic index
glycemic load
high protein diet
blood cholesterol

Additional relevant MeSH terms:
Overweight
Cardiovascular Diseases
Obesity
Body Weight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014