Glycemic Load, Weight Loss and Cardiovascular Disease Risk

• ClinicalTrials.gov Identifier: NCT00254215
• Recruitment Status: Completed
• First Posted: November 15, 2005
• Last Update Posted: November 28, 2006
• Sponsor: University of Sydney
• Collaborators: Meat & Livestock Australia; National Heart Foundation, Australia
• Information provided by: University of Sydney

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obesity	Behavioral: high protein & low glycemic index diets	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: March 2002
• Study Completion Date: October 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. weight loss at 12 weeks
2. Fat loss at 12 weeks
3. Lean mass change at 12 weeks

Secondary Outcome Measures :

1. Total cholesterol, LDL and HDL cholesterol change at 12 weeks
2. glucose, insulin & measures of insulin sensitivity change at 12 weeks
3. TG change at 12 weeks
4. Leptin change at 12 weeks
5. CRP change at 12 weeks

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• 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

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 of Results:

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
• Other Study ID Numbers: NHF G02S 0768 - Brand-Miller
• First Posted: November 15, 2005
• Last Update Posted: November 28, 2006
• Last Verified: July 2005

Keywords provided by University of Sydney:

overweight; obesity; glycemic index; glycemic load; high protein diet; blood cholesterol

Additional relevant MeSH terms:

Overweight; Body Weight