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

Last updated: March 3, 2025
Sponsor: Stephen Freedland
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Weight Loss

Prostate Disorders

Treatment

usual diet

phone counseling with dietitian

walnuts

Clinical Study ID

NCT03824652
IIT2018-23-Freedland-POWR
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically confirmed prostate adenocarcinoma.

  • Diagnostic biopsy cores with ≥10 cores with each core examined separately todetermine 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 perday.

  • Reads, writes, and understands English.

  • Age 18 or older

Exclusion

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 prostatecryotherapy.

  • Currently enrolled in a modified diet/weight loss program and/or taking dietarysupplements 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/drugaddiction, malabsorption syndromes), that in the opinion of the study physician makethe patient ineligible.

  • Individuals with psychological/mental conditions which can affect the consentprocess and/or their adherence to the protocol.

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: usual diet
Phase: 2
Study Start date:
April 22, 2019
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

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