Glycemic Load, Weight Loss and Cardiovascular Disease Risk

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254215
• Other study ID #: NHF G02S 0768 - Brand-Miller
• Status: Completed
• Phase: Phase 1
• First received: November 13, 2005
• Last updated: November 27, 2006
• Start date: March 2002
• Est. completion date: October 2004

Study information

• Verified date: July 2005
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• high protein & low glycemic index diets

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
University of Sydney	Meat & Livestock Australia, National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

References & 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 contro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss at 12 weeks
Primary	Fat loss at 12 weeks
Primary	Lean mass change at 12 weeks
Secondary	Total cholesterol, LDL and HDL cholesterol change at 12 weeks
Secondary	glucose, insulin & measures of insulin sensitivity change at 12 weeks
Secondary	TG change at 12 weeks
Secondary	Leptin change at 12 weeks
Secondary	CRP change at 12 weeks