Atkins Diet and Prostate Cancer Clinical Trial

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Behavioral: Atkins Diet

• Registration Number: NCT00932672
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 45

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atkins group	Atkins Diet	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.

Primary Outcome Measures

Name	Time	Method
The primary end-point will be differences in insulin sensitivity between the arms	6 months

Secondary Outcome Measures

Name	Time	Method
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)	6 months

Trial Locations

Locations (3)

Greater Los Angeles VA Medical Center; 🇺🇸 Los Angeles, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States