The Safety and Effectiveness of Low and High Carbohydrate Diets

Study Overview
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Brief Summary
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This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet).

Detailed Description
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Despite the considerable mass appeal of popular diet books, such diet approaches lack data to support their efficacy and safety. Despite its widespread use for more than 30 years, the Atkins diet has never been evaluated in a large, randomized, controlled trial. This study will assess the short-term and long-term clinical effects of a low-carbohydrate diet and a high-carbohydrate diet in overweight and obese men and women. Participants in this study will be randomly assigned to the Atkins diet (low-carbohydrate, unlimited fat and protein) or a conventional USDA diet (high-carbohydrate, low-fat). The study will evaluate the effects of each dietary approach on changes in: 1) weight and body composition; 2) metabolic and organ function; and 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.

Official Title
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The Safety and Efficacy of Low and High Carbohydrate Diets

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Low-calorie diet
* Behavioral: low-carbohydrate diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Body mass index between 30 and 40 Live and work within 1 hour of the study site Stable psychological status Exclusion criteria History of heart disease, heart attack, or stroke Blood pressure >140/90 mmHg Abnormal cholesterol levels Significant psychiatric illness Any medication that affects weight or metabolic rate Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer) Currently using antidepressants, steroids, tobacco, or illegal drugs Pregnant, breastfeeding, or planning pregnancy 10 lb change in weight within 6 months of study entry History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease History of protein wasting diseases or gout Severe arthritis Osteoporosis Certain types of hormone replacement therapy Currently following a vegetarian diet

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Low-calorie diet | Behavioral: Low-calorie diet<br>* low-calorie diet<br>|
| Experimental: 2<br>Low-carbohydrate diet | Behavioral: low-carbohydrate diet<br>* low-carbohydrate diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lipids |  | 2 years | 
| blood pressure change |  | 2 years | 
| Ketones |  | 2 years | 
| Endothelial Function |  | 2 | 
| change in exercise endurance |  | 2 years | 
| change in renal function |  | 2 years | 
| change in bone density |  | 2 years | 
| change in body composition |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss