Prostate Biomarkers in Men Consuming Tomato Products

November 12, 2014 updated by: Steven Clinton, Ohio State University Comprehensive Cancer Center
Prostate Biomarkers in Men Consuming Tomato Products

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants completed a minimum week-long washout period without consumption of tomato products prior to randomization to one of four dietary interventions. Men were randomized to one of the following dietary interventions: a controlled low lycopene diet (≤ 5 mg/d from foods), daily Prego® spaghetti sauce, daily V8® vegetable juice, or daily Campbell's® Tomato Soup. Each of the tomato products provided between 25 and 35 mg lycopene per day. In order to provide this dietary intervention in typical serving sizes in the context of a usual diet but devoid of other tomato sources, participants kept daily logs documenting compliance with the intervention product and a tomato-restricted diet from enrollment to the day of surgery (~3 weeks). Study participants were asked to complete an abbreviated dietary history questionnaire (to establish typical consumption patterns of various tomato products) and two separate 3-day diet food records, once during the washout and once during the intervention period. Blood and 24-hour urine samples were obtained at two time points, after the one-week washout phase and at the end of the dietary intervention period. Fresh prostate samples were obtained at time of surgery.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Comprehensive Cancer Center/ We

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria: To be included in this study, men must:

  • Have biopsy-proven, clinically localized adenocarcinoma of the prostate based on standard presurgical staging studies
  • Have chosen to undergo a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
  • Have kidney and liver enzymes, CBC, and PT/PTT/INR within normal limits
  • Agree to sign consent form prior to enrollment in the study

Exclusion Criteria: Men may not participate in this if they:

  • Are currently taking lycopene or "alternative" dietary supplements
  • Have a history of digestive or malabsorptive disorders, metabolic enzyme deficiencies, or other disorders requiring special dietary modifications (controlled type II diabetes mellitus was allowed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm I: Control
Men in this group consumed a tomato free diet for the duration of the study (less than or equal to 5 mg lycopene/day) and, thus, did not consume a tomato intervention product.
Experimental: Arm II: Juice
Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day).
Other: Commercially-available tomato food product
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
Experimental: Arm III: Soup
Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).
Other: Commercially-available tomato food product
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
Experimental: Arm IV: Sauce
Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day).
Other: Commercially-available tomato food product
Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure carotenoids, including lycopene and its isomers, in blood (umol/L) and prostate tissue (nmol/g) of men after three weeks of consuming V8 vegetable juice, condensed tomato soup or tomato sauce.
Time Frame: Day 0 and End of Study (an average of 23 days)
Day 0 and End of Study (an average of 23 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade (number 1 - 10), tumor volume (weight) , and vascular endothelial growth factor expression (ng/mL)
Time Frame: Day 0 and End of Study (an average of 23 days)
Measure histobiomarkers in the prostate related to aggressive disease including Gleason Grade, tumor volume, and vascular endothelial growth factor expression
Day 0 and End of Study (an average of 23 days)
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Time Frame: Day 0 and End of study (an average of 23 days)
Measure biomarkers related to prostate cancer in controls and men consuming tomato food products prior to surgery. These biomarkers include plasma insulin like growth factor (ng/mL) and plasma prostate specific antigen (ng/mL)
Day 0 and End of study (an average of 23 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

Schwartz, Steven, PhD

Investigators

  • Principal Investigator: Steven Clinton, MD, The Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-0137

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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