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Prostate Biomarkers in Men Consuming Tomato Products

NCT ID: NCT02292524

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2004-10-31

Brief Summary

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Prostate Biomarkers in Men Consuming Tomato Products

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm II: Juice

Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day).

Group Type EXPERIMENTAL

Commercially-available tomato food product

Intervention Type OTHER

Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Arm III: Soup

Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day).

Group Type EXPERIMENTAL

Commercially-available tomato food product

Intervention Type OTHER

Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Arm IV: Sauce

Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day).

Group Type EXPERIMENTAL

Commercially-available tomato food product

Intervention Type OTHER

Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Interventions

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Commercially-available tomato food product

Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Schwartz, Steven, PhD

UNKNOWN

Sponsor Role collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Steven Clinton

Steven Clinton

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Clinton, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Comprehensive Cancer Center

Locations

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The Ohio State University Comprehensive Cancer Center/ We

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://cancer.osu.edu

The Jamesline

Other Identifiers

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OSU-0137

Identifier Type: -

Identifier Source: org_study_id