Glycemic Load, Weight Loss and Cardiovascular Disease Risk - Full Text View

Sponsor:	University of Sydney
Collaborators:	Meat & Livestock Australia National Heart Foundation, Australia
Information provided by:	University of Sydney
ClinicalTrials.gov Identifier:	NCT00254215

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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: Cholesterol Diets Obesity 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

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Contacts and Locations

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.

Study ID Numbers:	NHF G02S 0768 - Brand-Miller
Study First Received:	November 13, 2005
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00254215 History of Changes
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:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overnutrition
Overweight
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010