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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00200720
First received: September 12, 2005
Last updated: December 4, 2012
Last verified: February 2008

September 12, 2005
December 4, 2012
April 2005
March 2009   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Excess weight loss (greater than 5 pounds a week)would trigger patient assessment.
Weight loss; measured over 30 months
Complete list of historical versions of study NCT00200720 on ClinicalTrials.gov Archive Site
  • Risk of cardiovascular disease [ Time Frame: Every six months ] [ Designated as safety issue: Yes ]
    Elevated lipids or rising blood pressure during six month safety assessments would trigger additional participant evaluation
  • bone health [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • kidney function [ Time Frame: every six months ] [ Designated as safety issue: No ]
  • neuroendocrine mechanisms of hunger and satiety [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Risk of cardiovascular disease; measured after 30 months
  • Bone health and kidney function; measured after 30 months
  • Neuroendocrine mechanisms; measured after 30 months
Not Provided
Not Provided
 
Effectiveness of a Low Carbohydrate Diet Versus a High Carbohydrate Diet in Promoting Weight Loss and Improved Health
Metabolic Consequences of High and Low Carbohydrate Diets

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Hypertension
  • Behavioral: Atkins diet (low carbohydrate diet)
  • Behavioral: DASH diet (high carbohydrate diet)
  • 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.
    Intervention: 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
    Intervention: Behavioral: DASH diet (high carbohydrate diet)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
June 2010
March 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00200720
R21 AT000525-01, R21AT000525-01, 1R01AT001930
Yes
Kaiser Permanente
Kaiser Permanente
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Njeri Karanja, PhD Kaiser Permanente Northwest, Center for Health Research
Kaiser Permanente
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP