Glycemic Load, Weight Loss and Cardiovascular Disease Risk

Study Overview
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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.

Official Title
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The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: high protein & low glycemic index diets


Participation Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: high protein & low glycemic index diets|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss at 12 weeks |  |  | 
| Fat loss at 12 weeks |  |  | 
| Lean mass change at 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, overweight, glycemic index, glycemic load, high protein diet, blood cholesterol