Atkins Diet and Prostate Cancer Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Atkins Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atkins group<br>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<br>* Patients are given an outline of the Atkins diet and are asked to follow it for 6 months<br>* Other names: Cases;|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point will be differences in insulin sensitivity between the arms |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Atkins