| March 9, 2004 |
| January 2, 2008 |
| April 2003 |
| March 2008 (final data collection date for primary outcome measure) |
| weight change [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00079547 on ClinicalTrials.gov Archive Site |
- change in lipids [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- blood pressure change [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Ketones [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Endothelial Function [ Time Frame: 2 ] [ Designated as safety issue: No ]
- change in exercise endurance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- change in renal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- change in bone density [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- change in body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| The Safety and Effectiveness of Low and High Carbohydrate Diets |
| The Safety and Efficacy of Low and High Carbohydrate Diets |
This study will compare the safety and the effectiveness of a low carbohydrate diet (Atkins diet) with a high carbohydrate diet (conventional USDA diet). |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Obesity |
- Behavioral: Low-calorie diet
- Behavioral: low-carbohydrate diet
|
- Active Comparator: Low-calorie diet
- Experimental: Low-carbohydrate diet
|
| |
| |
| Active, not recruiting |
| 307 |
| March 2008 |
| March 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 65 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00079547 |
| Gary D. Foster, Ph.D., Temple University |
| R01 AT001103-01, R01 AT001103-01 |
| National Center for Complementary and Alternative Medicine (NCCAM) |
- Office of Dietary Supplements (ODS)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Heart, Lung, and Blood Institute (NHLBI)
|
| Principal Investigator: |
Gary D Foster, PhD |
University of Pennsylvania |
|
| Principal Investigator: |
Holly Wyatt, MD |
University of Colorado at Denver and Health Sciences Center |
|
| Principal Investigator: |
James Hill, PhD |
University of Colorado at Denver and Health Sciences Center |
|
| Principal Investigator: |
Samuel Klein, MD |
Washington University School of Medicine |
|
|
| National Center for Complementary and Alternative Medicine (NCCAM) |
| January 2008 |