Obesity
Conditions
Keywords
Weight Loss
Brief summary
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
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.
Interventions
BEHAVIORALLow-calorie diet
low-calorie diet
BEHAVIORALlow-carbohydrate diet
low-carbohydrate diet
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight change | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure change | 2 years |
| Ketones | 2 years |
| Endothelial Function | 2 |
| change in lipids | 2 years |
| change in renal function | 2 years |
| change in bone density | 2 years |
| change in body composition | 2 years |
| change in exercise endurance | 2 years |
Countries
United States
Outcome results
None listed