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

History of Changes

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:

MedlinePlus related topics: Weight Control

U.S. FDA Resources

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

McMillan-Price J, Petocz P, Atkinson F, O'neill K, Samman S, Steinbeck K, Caterson I, Brand-Miller J. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1466-75.


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

ClinicalTrials.gov processed this record on February 27, 2015

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