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Sponsors and Collaborators: |
Duke University VA Greater Los Angeles Healthcare System Durham VA Medical Center University of California, Los Angeles Santa Monica UCLA Medical Center |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00932672 |
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 |
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Prostate Cancer |
Behavioral: Atkins Diet |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer |
Estimated Enrollment: | 90 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | July 2012 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Atkins group: Experimental
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 first 6 months of the study and then every other month during the second 6 months of the study (i.e. months 8, 10, and 12). 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 12 months
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Control group: No Intervention
Subjects assigned to the waitlist control group will be asked to make no changes in their dietary habits. At the completion of the study (at month 12 and an 18-month follow-up), subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Loretta A Taylor, B.S. | 919-684-4896 | loretta.taylor@duke.edu |
United States, California | |
Greater Los Angeles VA Medical Center | Not yet recruiting |
Los Angeles, California, United States, 90073 | |
Contact: Loretta Taylor, B.S. 919-684-4896 loretta.taylor@duke.edu | |
Principal Investigator: William Aronson, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Loretta Taylor, B.S. 919-684-4896 loretta.taylor@duke.edu | |
Principal Investigator: Stephen J Freedland, MD |
Principal Investigator: | Stephen J Freedland, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Stephen J. Freedland, MD/Associate Professor of Urology and Pathology ) |
Study ID Numbers: | 00010519 |
Study First Received: | July 2, 2009 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00932672 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Atkins |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Androgens |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |