We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Atkins Diet and Prostate Cancer Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00932672
Recruitment Status : Terminated (slow recruitment, lack of funding and PI transferred)
First Posted : July 3, 2009
Last Update Posted : December 7, 2015
VA Greater Los Angeles Healthcare System
Durham VA Medical Center
University of California, Los Angeles
Carolina Urologic Research Center
First Urology
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Atkins Diet Phase 2

Detailed Description:
Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
Study Start Date : June 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Atkins group
Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to <20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the 6 months of the study. Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.
Behavioral: Atkins Diet
Patients are given an outline of the Atkins diet and are asked to follow it for 6 months
Other Names:
  • Atkins group
  • Cases

No Intervention: Control group
Subjects assigned to the control group will be asked to make no changes in their dietary habits. At the completion of the study subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.

Primary Outcome Measures :
  1. The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Measures will include other cardiac risk factors, overall body morphometrics, body composition as assessed by dual energy x-ray absorptiometry (DXA), and cancer control (PSA levels) [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
  3. Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion Criteria:

  1. Symptomatic metastatic disease
  2. Myocardial infarction within 6 months
  3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
  4. Patient consuming a low-carbohydrate diet
  5. Medical conditions or co-morbidities that preclude participation in the protocol
  6. Vegetarians

Information from the National Library of Medicine

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): NCT00932672

Layout table for location information
United States, California
Greater Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
VA Greater Los Angeles Healthcare System
Durham VA Medical Center
University of California, Los Angeles
Carolina Urologic Research Center
First Urology
Layout table for investigator information
Principal Investigator: Stephen J Freedland, MD Duke University
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00932672    
Other Study ID Numbers: Pro00010519
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Keywords provided by Duke University:
Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases