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
  Purpose

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 Intervention Phase
Prostate Cancer
Behavioral: Atkins Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • The primary end-point will be differences in insulin sensitivity between the arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932672

Contacts
Contact: Jennifer Stout 919-613-3786 jennifer.stout@duke.edu

Locations
United States, California
Greater Los Angeles VA Medical Center Recruiting
Los Angeles, California, United States, 90073
Contact: Sherry Jeffery       SJeffery@mednet.ucla.edu   
Principal Investigator: William Aronson, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Sherry Jeffery       SJeffery@mednet.ucla.edu   
Principal Investigator: William Aronson, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Stout    919-613-3786    jennifer.stout@duke.edu   
Principal Investigator: Stephen J Freedland, MD         
Sponsors and Collaborators
Duke University
VA Greater Los Angeles Healthcare System
Durham VA Medical Center
University of California, Los Angeles
Investigators
Principal Investigator: Stephen J Freedland, MD Duke University
  More Information

Additional Information:
Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00932672     History of Changes
Other Study ID Numbers: Pro00010519
Study First Received: July 2, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Prostate Cancer
Atkins

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014