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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2008 by National Center for Complementary and Alternative Medicine (NCCAM). Recruitment status was Active, not recruiting

First Received on September 12, 2005. Last Updated on February 26, 2008 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00200720

Purpose

This study will examine the effects of a low carbohydrate diet versus a high carbohydrate diet on weight loss.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Metabolic Consequences of High and Low Carbohydrate Diets

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Obesity Weight Control

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Weight loss

Secondary Outcome Measures:

Risk of cardiovascular disease
bone health
kidney function
neuroendocrine mechanisms

Estimated Enrollment:	240
Study Start Date:	April 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200720

Locations

United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Njeri Karanja, PhD

Kaiser Permanente Northwest, Center for Health Research

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00200720 History of Changes
Other Study ID Numbers:	R21 AT000525-01, 1 RO1 AT001930
Study First Received:	September 12, 2005
Last Updated:	February 26, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Diet
Carbohydrates
Weight Loss

Additional relevant MeSH terms:

Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition

Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012