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 — OTHER
    2 ounces of walnuts daily for 4-10 weeks
  • usual diet — OTHER
    Subject continues usual diet
  • phone counseling with dietitian — OTHER
    Weekly 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

Start date
Apr 22, 2019
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Usual Diet + Walnuts
    Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
  • Active Comparator: Usual Diet
    Usual 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

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Kara Bissell
424-314-0743
Stephen Freedland, MD (PRINCIPAL_INVESTIGATOR)

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