NCT03824652

WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stephen Freedland · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	walnuts	2 ounces of walnuts daily for 4-10 weeks
OTHER	usual diet	Subject continues usual diet
OTHER	phone counseling with dietitian	Weekly calls with dietitian

Timeline

• Start date: 2019-04-22
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2019-01-31
• Last updated: 2026-02-04

Locations

2 sites across 1 country: United States