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Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

NCT01823562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-20

Study results available
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Summary

This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.

Conditions

  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer

Interventions

DRUG

lyophilized black raspberry confection

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

DIETARY_SUPPLEMENT

dietary intervention

Follow a low polyphenol diet

DIETARY_SUPPLEMENT

dietary intervention

Follow a low ellagitannin diet

PROCEDURE

quality-of-life assessment

Ancillary studies

OTHER

questionnaire administration

Ancillary studies

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Steven Clinton · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-17
Primary Completion
2013-08-01
Completion
2025-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823562 on ClinicalTrials.gov