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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT001103-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Low-calorie diet |
|
| 2 | Experimental | Low-carbohydrate diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-calorie diet | Behavioral | low-calorie diet |
| |
| low-carbohydrate diet |
| Measure | Description | Time Frame |
|---|---|---|
| weight change | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| change in lipids | 2 years | |
| blood pressure change | 2 years | |
| Ketones |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Gary D Foster, PhD | University of Pennsylvania | Principal Investigator |
| Holly Wyatt, MD | University of Colorado, Denver | Principal Investigator |
| James Hill, PhD | University of Colorado, Denver | Principal Investigator |
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80262 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20082927 | Derived | de las Fuentes L, Waggoner AD, Mohammed BS, Stein RI, Miller BV 3rd, Foster GD, Wyatt HR, Klein S, Davila-Roman VG. Effect of moderate diet-induced weight loss and weight regain on cardiovascular structure and function. J Am Coll Cardiol. 2009 Dec 15;54(25):2376-81. doi: 10.1016/j.jacc.2009.07.054. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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| Behavioral |
low-carbohydrate diet |
|
| 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 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |