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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health | ||||
| Official Title † | Metabolic Consequences of High and Low Carbohydrate Diets | ||||
| Brief Summary | This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss. |
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| Detailed Description | The number of overweight and obese Americans has increased significantly in recent years. There are now many different diet plans being promoted by doctors and the media. The Atkins diet, a low carbohydrate nutritional plan, is especially popular; its advocates claim that following the diet will result in long-term weight loss with no negative effects. Another diet, called the Dietary Approaches to Stop Hypertension (DASH) diet, is a high carbohydrate diet designed to help treat and prevent high blood pressure. However, more thorough investigation of these claims is needed. This study will compare the short- and long-term effects of the Atkins diet to the (DASH) diet. This trial will enroll overweight and obese participants. This study will last 30 months and will comprise two phases. Participants will be randomly assigned to either the Atkins or DASH diet for 30 months. During Phase 1, all participants will undergo 6 months of weekly group therapy to encourage weight loss. Phase 2 is a weight loss maintenance phase. During Phase 2, participants will have monthly meetings with a therapist for weight loss support. Study visits will occur at study entry and at Months 3 and 30. At each study visit, weight measurements, blood and urine collection, and x-rays will occur to determine participants' weight loss, cardiovascular health, kidney function, and bone density. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Weight loss | ||||
| Secondary Outcome Measure † | Risk of cardiovascular disease bone health kidney function neuroendocrine mechanisms |
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| Condition † | Obesity Hypertension |
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| Intervention † | Behavioral: Atkins diet (low carbohydrate diet) Behavioral: Dietary Approaches to Stop Hypertension (DASH) diet (high carbohydrate diet) |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 240 | ||||
| Start Date † | April 2005 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00200720 | ||||
| Organization ID | R21 AT000525-01 | ||||
| Secondary IDs †† | 1 RO1 AT001930 | ||||
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | February 26, 2008 | ||||