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

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ClinicalTrials.gov Identifier: NCT03824652
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Stephen Freedland, Cedars-Sinai Medical Center

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 6-10 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 6-10 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Usual Diet + Walnuts
Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 6-10 weeks
Other: walnuts
2 ounces of walnuts daily for 6-10 weeks

Other: usual diet
Subject continues usual diet

Other: phone counseling with dietitian
Weekly calls with dietitian

Active Comparator: Usual Diet
Usual diet for 6-10 weeks
Other: usual diet
Subject continues usual diet




Primary Outcome Measures :
  1. Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP [ Time Frame: 10 weeks ]
    Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

  2. Mean difference in prostatic tissue inflammation from baseline biopsy to RP [ Time Frame: 10 weeks ]
    Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed prostate adenocarcinoma with biopsy tissue available for analysis.
  • Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
  • Biopsy grade group 2 or higher (Gleason ≥7).
  • Scheduled 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 and has access to a computer or a Smartphone to complete ASA24 food diary.

Exclusion Criteria:

  • Allergy to walnuts.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824652


Contacts
Contact: Dana Levin, MPH 310-423-0333 Dana.Levin@cshs.org
Contact: Laura Lockshon 424-315-2219 Laura.Lockshon@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Stephen Freedland
California Walnut Commission
Investigators
Principal Investigator: Stephen Freedland, MD Cedars-Sinai Medical Center

Responsible Party: Stephen Freedland, Professor, Surgery, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03824652     History of Changes
Other Study ID Numbers: IIT2018-23-Freedland-POWR
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephen Freedland, Cedars-Sinai Medical Center:
prostate cancer
prostate adenocarcinoma
diet
walnuts
radical prostatectomy
omega-3 fatty acids
polyphenols

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Weight Loss
Genital Diseases, Male
Body Weight Changes
Body Weight
Signs and Symptoms