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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

walnuts

usual diet

phone counseling with dietitian

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, prostate adenocarcinoma, diet, walnuts, radical prostatectomy, omega-3 fatty acids, polyphenols

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Cedars-Sinai Medical CenterRecruiting
Durham VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Usual Diet + Walnuts

Usual Diet

Arm Description

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

Usual diet for 4-10 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

Mean difference in prostatic tissue inflammation from baseline biopsy to RP

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

Full Information

NCT ID

NCT03824652

First Posted

January 29, 2019

Last Updated

October 5, 2023

Sponsor

Stephen Freedland

Collaborators

California Walnut Commission

1. Study Identification

Unique Protocol Identification Number

NCT03824652

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 22, 2019 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stephen Freedland

Collaborators

California Walnut Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostate cancer, prostate adenocarcinoma, diet, walnuts, radical prostatectomy, omega-3 fatty acids, polyphenols

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual Diet + Walnuts

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Diet

Arm Type

Active Comparator

Arm Description

Usual diet for 4-10 weeks

Intervention Type

Other

Intervention Name(s)

walnuts

Intervention Description

2 ounces of walnuts daily for 4-10 weeks

Intervention Type

Other

Intervention Name(s)

usual diet

Intervention Description

Subject continues usual diet

Intervention Type

Other

Intervention Name(s)

phone counseling with dietitian

Intervention Description

Weekly calls with dietitian

Primary Outcome Measure Information:

Title

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

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

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

Description

Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

Time Frame

10 weeks

Title

Mean difference in prostatic tissue inflammation from baseline biopsy to RP

Description

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

Time Frame

10 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunhee Choi-Kuaea, MSW

Phone

310-423-0333

Yunhee.Choi-Kuaea@cshs.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Freedland, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunhee Choi-Kuaea, MSW

Phone

310-423-0333

Yunhee.Choi-Kuaea@cshs.org

First Name & Middle Initial & Last Name & Degree

Stephen Freedland, MD

Facility Name

Durham VA Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aubrey Jarman, RD

Phone

919-286-0411

Aubrey.Jarman@va.gov

12. IPD Sharing Statement

Learn more about this trial

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

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