NCT00254215

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
Last Updated

November 28, 2006

Status Verified

July 1, 2005

First QC Date

November 13, 2005

Last Update Submit

November 27, 2006

Conditions

OverweightObesity

Keywords

overweightobesityglycemic indexglycemic loadhigh protein dietblood cholesterol

Outcome Measures

Primary Outcomes (3)

  • weight loss at 12 weeks

  • Fat loss at 12 weeks

  • Lean mass change at 12 weeks

Secondary Outcomes (5)

  • 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

Interventions

high protein & low glycemic index dietsBEHAVIORAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age BMI \>=25 stable weight for 3 months non-vegetarian good understanding of English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

Related Publications (1)

  • 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.

    PMID: 16864756RESULT

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jennie C Brand-Miller, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2005

First Posted

November 15, 2005

Study Start

March 1, 2002

Study Completion

October 1, 2004

Last Updated

November 28, 2006

Record last verified: 2005-07

Locations

AU(1)