Status:

COMPLETED

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

Lead Sponsor:

Kaiser Permanente

Collaborating Sponsors:

National Center for Complementary and Integrative Health (NCCIH)

Conditions:

Obesity

Hypertension

Eligibility:

All Genders

21+ years

Phase:

PHASE2

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 carboh...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT00200720

Start Date

April 1 2005

End Date

June 1 2010

Last Update

December 6 2012

Active Locations (1)

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Kaiser Permanente Center for Health Research

Portland, Oregon, United States, 97227