WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Status
RECRUITING
Phase
PHASE2
Age
≥ 18 Years
Enrollments
50Conditions
Prostate CancerSummary
This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.
Detailed Description
The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Kara Bissell
- 424-314-0743
- [email protected]
Principal Investigator
- Stephen Freedland, MD
Status
- RECRUITING
Contact Person
- Haleigh E Bellerose
- 919-286-0411
- [email protected]
Principal Investigator
- Stephen Freedland, MD
Eligibility Criteria
Inclusion Criteria:
* Pathologically confirmed prostate adenocarcinoma.
* Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
* Biopsy grade group 2 or higher (Gleason ≥7).
* Planning to undergo RP.
* Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.
* Reads, writes, and understands English.
* Age 18 or older
Exclusion Criteria:
* Allergy to nuts.
* History of receiving hormone therapy or antiandrogen therapy.
* Use of 5-alpha reductase inhibitors in the past 6 months.
* Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.
* Currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil).
* Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
* Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible.
* Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.
Study Plan
Usual Diet + Walnuts
EXPERIMENTAL
Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
OTHER:
walnutsDescription:
2 ounces of walnuts daily for 4-10 weeksOTHER:
usual dietDescription:
Subject continues usual dietOTHER:
phone counseling with dietitianDescription:
Weekly calls with dietitian
Usual Diet
ACTIVE_COMPARATOR
Usual diet for 4-10 weeks
OTHER:
usual dietDescription:
Subject continues usual diet
Outcome Measures
Primary Outcome Measures
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP
Secondary Outcome Measures
Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP
Mean difference in prostatic tissue inflammation from baseline biopsy to RP
Timeline
Last Updated
October 8, 2024Start Date
January 31, 2019Today
February 5, 2025Completion Date ( Estimated )
January 1, 2026
Sponsors of this trial
Lead Sponsor
Stephen FreedlandCollaborating Sponsors
California Walnut Commission
RECRUITING 
21 - 64 Years