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Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health

This study is ongoing, but not recruiting participants.
Study NCT00200720.   Last updated on February 26, 2008.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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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.

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.

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
Condition  Obesity
Hypertension
Intervention  Behavioral: Atkins diet (low carbohydrate diet)
Behavioral: Dietary Approaches to Stop Hypertension (DASH) diet (high carbohydrate diet)
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:

  • Body mass index (BMI) of 27 to 50
  • Fasting glucose less than 126 mg/dl
  • Total fasting cholesterol less than 260 mg/dl
  • Total fasting triglycerides less than 400 mg/dl
  • Permission of primary care provider to participate in the study
  • Normal liver and kidney function
  • Willing to modify diet and other health behaviors
  • Willing to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

  • Any medical condition that may make weight loss medically inadvisable
  • Weigh more than 400 lbs
  • History of kidney failure
  • Current use of more than 3 blood pressure medications
  • Change in blood pressure medications within 3 months prior to study entry
  • Diagnosis of cardiovascular disease within 6 months prior to study entry
  • Cancer diagnosis within 2 years of study entry. Participants with basal cell skin cancer are not excluded.
  • History of psychiatric hospitalization within 2 years prior to study entry
  • Consumption of more than three alcoholic drinks a day
  • Type I or II diabetes
  • Current use of hypolipidemics, antipsychotics, hypoglycemics, glucocorticoids, or thyroid medication
  • Plan to move during study
  • Current participation in another clinical trial
  • Pregnancy or breastfeeding
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 
Principal Investigator:     Njeri Karanja, PhD     Kaiser Permanente Northwest, Center for Health Research    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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