Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health
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|ClinicalTrials.gov Identifier: NCT00200720|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Hypertension||Behavioral: Atkins diet (low carbohydrate diet) Behavioral: DASH diet (high carbohydrate diet)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Consequences of High and Low Carbohydrate Diets|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2010|
Experimental: Atkins Diet
Participants randomized to this arm will consume a low carbohydrate diet as described by Dr. Robert Atkins in his book: Dr. Atkins' New Diet Revolution New York: Avon Books, 2002.
Behavioral: Atkins diet (low carbohydrate diet)
Active Comparator: DASH Diet
Participants randomized to this arm will consume the Dietary Approaches to Stop Hypertension (DASH) diet as described here: http://www.nhlbi.nih.gov/health/public/heart/hbp/dash/new_dash.pdf
Behavioral: DASH diet (high carbohydrate diet)
- Weight loss [ Time Frame: monthly ]Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.
- Risk of cardiovascular disease [ Time Frame: Every six months ]Elevated lipids or rising blood pressure during six month safety assessments would trigger additional participant evaluation
- bone health [ Time Frame: end of study ]
- kidney function [ Time Frame: every six months ]
- neuroendocrine mechanisms of hunger and satiety [ Time Frame: end of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00200720
|United States, Oregon|
|Kaiser Permanente Center for Health Research|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Njeri Karanja, PhD||Kaiser Permanente|