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Atkins Diet and Prostate Cancer Clinical Trial

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atkins Diet
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Atkins

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Greater Los Angeles VA Medical Center
  • University of California, Los Angeles
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Atkins group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The primary end-point will be differences in insulin sensitivity between the arms

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)

Full Information

First Posted
July 2, 2009
Last Updated
December 4, 2015
Sponsor
Duke University
Collaborators
VA Greater Los Angeles Healthcare System, Durham VA Medical Center, University of California, Los Angeles, Carolina Urologic Research Center, First Urology
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1. Study Identification

Unique Protocol Identification Number
NCT00932672
Brief Title
Atkins Diet and Prostate Cancer Clinical Trial
Official Title
Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment, lack of funding and PI transferred
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
VA Greater Los Angeles Healthcare System, Durham VA Medical Center, University of California, Los Angeles, Carolina Urologic Research Center, First Urology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Atkins

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atkins group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Atkins Diet
Other Intervention Name(s)
Atkins group, Cases
Intervention Description
Patients are given an outline of the Atkins diet and are asked to follow it for 6 months
Primary Outcome Measure Information:
Title
The primary end-point will be differences in insulin sensitivity between the arms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Scheduled to initiate ADT with an anticipated duration of ≥ 6 months Overweight or obese (body mass index ≥ 25 kg/m2) Exclusion Criteria: Symptomatic metastatic disease Myocardial infarction within 6 months Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.) Patient consuming a low-carbohydrate diet Medical conditions or co-morbidities that preclude participation in the protocol Vegetarians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Freedland, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Los Angeles VA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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derived
Links:
URL
http://www.atkins.com
Description
Atkins Diet Weight Loss Program

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Atkins Diet and Prostate Cancer Clinical Trial

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