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Atkins Diet and Prostate Cancer Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Duke University
Sponsor:
Collaborators:
VA Greater Los Angeles Healthcare System
Durham VA Medical Center
University of California, Los Angeles
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00932672
First received: July 2, 2009
Last updated: June 10, 2014
Last verified: June 2014

July 2, 2009
June 10, 2014
June 2009
December 2014   (final data collection date for primary outcome measure)
The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00932672 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Atkins Diet and Prostate Cancer Clinical Trial
Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prostate Cancer
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
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Jennifer Stout 919-613-3786 jennifer.stout@duke.edu
United States
 
NCT00932672
Pro00010519
No
Duke University
Duke University
  • VA Greater Los Angeles Healthcare System
  • Durham VA Medical Center
  • University of California, Los Angeles
Principal Investigator: Stephen J Freedland, MD Duke University
Duke University
June 2014

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