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Glycemic Load, Weight Loss and Cardiovascular Disease Risk

NCT ID: NCT00254215

Last Updated: 2006-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Keywords

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overweight obesity glycemic index glycemic load high protein diet blood cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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high protein & low glycemic index diets

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meat & Livestock Australia

UNKNOWN

Sponsor Role collaborator

National Heart Foundation, Australia

OTHER

Sponsor Role collaborator

University of Sydney

OTHER

Sponsor Role lead

Principal Investigators

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Jennie C Brand-Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

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University of Sydney

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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. doi: 10.1001/archinte.166.14.1466.

Reference Type RESULT
PMID: 16864756 (View on PubMed)

Other Identifiers

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NHF G02S 0768 - Brand-Miller

Identifier Type: -

Identifier Source: org_study_id