WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Stephen Freedland
- Study ID
- NCT03824652
- Phase
- PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- walnuts — OTHER2 ounces of walnuts daily for 4-10 weeks
- usual diet — OTHERSubject continues usual diet
- phone counseling with dietitian — OTHERWeekly calls with dietitian
Study Details
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.
Key Dates
- First listed
- Jan 31, 2019
- Start date
- Apr 22, 2019
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Usual Diet + WalnutsUsual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
- Active Comparator: Usual DietUsual diet for 4-10 weeks
Primary Outcome Measure
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP [ Time Frame: 10 weeks ]
Central Contacts
- Clinical Trials Navigator310-423-5842
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Stephen Freedland, MD (PRINCIPAL_INVESTIGATOR) |
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