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

Sponsor

Stephen Freedland (Other)

Overall Status

Recruiting

CT.gov ID

NCT03824652

Collaborator

California Walnut Commission (Other)

Enrollment

Location

Arms

56.3

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Other: walnuts Other: usual diet Other: phone counseling with dietitian	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 22, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Usual Diet + Walnuts Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks	Other: walnuts 2 ounces of walnuts daily for 4-10 weeks Other: usual diet Subject continues usual diet Other: phone counseling with dietitian Weekly calls with dietitian
Active Comparator: Usual Diet Usual diet for 4-10 weeks	Other: usual diet Subject continues usual diet

Arm

Intervention/Treatment

Experimental: Usual Diet + Walnuts

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

Other: walnuts

2 ounces of walnuts daily for 4-10 weeks

Other: usual diet

Subject continues usual diet

Other: phone counseling with dietitian

Weekly calls with dietitian

Active Comparator: Usual Diet

Usual diet for 4-10 weeks

Other: usual diet

Subject continues usual diet

Outcome Measures

Primary Outcome Measures

Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP [10 weeks]

Secondary Outcome Measures

Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP [10 weeks]
Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
Mean difference in prostatic tissue inflammation from baseline biopsy to RP [10 weeks]
Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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.