WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weig... | NCT03824652

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

NCT03824652

Sponsor

Stephen Freedland

Status

Recruiting

Last Update Posted

May 7, 2026Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

walnuts
usual diet
phone counseling with dietitian

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 22, 2019Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2027Estimated

First Submitted Date

Jan 29, 2019

First Submission Date that Met QC Criteria

Jan 29, 2019

First Posted Date

Jan 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2026

Last Update Posted Date

May 7, 2026Actual

Name	Class
California Walnut Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Diet + Walnuts	Experimental	Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks	Other: walnuts Other: usual diet Other: phone counseling with dietitian
Usual Diet	Active Comparator	Usual diet for 4-10 weeks	Other: usual diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
walnuts	Other	2 ounces of walnuts daily for 4-10 weeks	Usual Diet + Walnuts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP	Measured by prostate tissue 8-hydroxy-2-deoxyguanosine	10 weeks
Mean difference in prostatic tissue inflammation from baseline biopsy to RP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Navigator	Contact	310-423-0333		GroupCancerTrialInformation@cshs.org

Overall Officials

Name	Affiliation	Role
Stephen Freedland, MD	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center	Recruiting	Los Angeles	California	90048	United States

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services