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Atkins Diet and Prostate Cancer Clinical Trial

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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
Sponsor:
Collaborators:
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

Tracking Information
First Submitted Date  ICMJE July 2, 2009
First Posted Date  ICMJE July 3, 2009
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2009)
The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00932672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2009)
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: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atkins Diet and Prostate Cancer Clinical Trial
Official Title  ICMJE Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Atkins Diet
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 4, 2015)
45
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2009)
90
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00932672
Other Study ID Numbers  ICMJE Pro00010519
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • VA Greater Los Angeles Healthcare System
  • Durham VA Medical Center
  • University of California, Los Angeles
  • Carolina Urologic Research Center
  • First Urology
Investigators  ICMJE
Principal Investigator: Stephen J Freedland, MD Duke University
PRS Account Duke University
Verification Date December 2015

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