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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-22

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Diet + Walnuts

Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks

Group Type EXPERIMENTAL

walnuts

Intervention Type OTHER

2 ounces of walnuts daily for 4-10 weeks

usual diet

Intervention Type OTHER

Subject continues usual diet

phone counseling with dietitian

Intervention Type OTHER

Weekly calls with dietitian

Usual Diet

Usual diet for 4-10 weeks

Group Type ACTIVE_COMPARATOR

usual diet

Intervention Type OTHER

Subject continues usual diet

Interventions

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walnuts

2 ounces of walnuts daily for 4-10 weeks

Intervention Type OTHER

usual diet

Subject continues usual diet

Intervention Type OTHER

phone counseling with dietitian

Weekly calls with dietitian

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No