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NCT Number: NCT03824652

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Kara Bissell

CONTACT

[email protected]

424-314-0743

Stephen Freedland, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP

    Time frame: 10 weeks

Secondary outcomes

  1. Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP

    Time frame: 10 weeks

    Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

  2. Mean difference in prostatic tissue inflammation from baseline biopsy to RP

    Time frame: 10 weeks

    Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Navigator

CONTACT

[email protected]

310-423-0333

Sponsors and collaborators

Lead sponsor

Stephen Freedland

Other

Collaborators

  • California Walnut Commission

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 31, 2019
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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