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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 : Recruiting
First Posted : January 31, 2019
Last Update Posted : July 27, 2020
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Stephen Freedland, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE January 31, 2019
Last Update Posted Date July 27, 2020
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP [ Time Frame: 10 weeks ]
    Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Official Title  ICMJE WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Usual Diet + Walnuts
    Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
    Interventions:
    • Other: walnuts
    • Other: usual diet
    • Other: phone counseling with dietitian
  • Active Comparator: Usual Diet
    Usual diet for 4-10 weeks
    Intervention: Other: usual diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monica Guerrero 424-315-2215 monica.guerrero@cshs.org
Contact: Laura Lockshon 424-315-2219 Laura.Lockshon@cshs.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03824652
Other Study ID Numbers  ICMJE IIT2018-23-Freedland-POWR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Freedland, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Stephen Freedland
Collaborators  ICMJE California Walnut Commission
Investigators  ICMJE
Principal Investigator: Stephen Freedland, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP