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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT001103-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institutes of Health (NIH) | NIH |
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This study will compare the safety and 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, 3) exercise tolerance. Each participant will be enrolled in the study for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Carb | Active Comparator | Low Cabohydrate Diet: 20 week of weekly group behavior modification, 20 weekly bi-weekly, bi-monthly to finish |
|
| Low Calorie | Active Comparator | Low Calorie Diet: 20 weeks of weekly behavior modification, 20 weekly of bi-weekly, bimonthly to finish 2 years |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low- Carbohydrate -Atkins Diet | Behavioral | Low Carbohydrate Diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary 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 | United States | |||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22653255 | Derived | Friedman AN, Ogden LG, Foster GD, Klein S, Stein R, Miller B, Hill JO, Brill C, Bailer B, Rosenbaum DR, Wyatt HR. Comparative effects of low-carbohydrate high-protein versus low-fat diets on the kidney. Clin J Am Soc Nephrol. 2012 Jul;7(7):1103-11. doi: 10.2215/CJN.11741111. Epub 2012 May 31. | |
| 21760633 | Derived | Borradaile KE, Halpern SD, Wyatt HR, Klein S, Hill JO, Bailer B, Brill C, Stein RI, Miller BV 3rd, Foster GD. Relationship between treatment preference and weight loss in the context of a randomized controlled trial. Obesity (Silver Spring). 2012 Jun;20(6):1218-22. doi: 10.1038/oby.2011.216. Epub 2011 Jul 14. |
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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 |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Low Calorie Diet | Behavioral | Maintain a low calorie diet |
|
|
| St Louis |
| Missouri |
| United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| 20679559 | Derived | Foster GD, Wyatt HR, Hill JO, Makris AP, Rosenbaum DL, Brill C, Stein RI, Mohammed BS, Miller B, Rader DJ, Zemel B, Wadden TA, Tenhave T, Newcomb CW, Klein S. Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial. Ann Intern Med. 2010 Aug 3;153(3):147-57. doi: 10.7326/0003-4819-153-3-201008030-00005. |
| 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 |