Health TrialsbyHealthPanel

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

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorStephen Freedland

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • walnuts

    Other intervention

    2 ounces of walnuts daily for 4-10 weeks

  • usual diet

    Other intervention

    Subject continues usual diet

  • phone counseling with dietitian

    Other intervention

    Weekly calls with dietitian

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Usual Diet + WalnutsExperimental treatment 3 interventions
Group B: Usual DietActive comparator 1 intervention

Trial outcomes

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

Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

Time frame
10 weeks
2

Mean difference in prostatic tissue inflammation from baseline biopsy to RP

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

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephen Freedland

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

California Walnut Commission

Collaborator

Source ClinicalTrials.gov
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