Prostate Biomarkers in Men Consuming Tomato Products

The Ohio State University

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Commercially-available tomato food product

Study type: Interventional

Funder types: Other

Identifiers

NCT02292524

OSU-0137

Details and patient eligibility

About

Prostate Biomarkers in Men Consuming Tomato Products

Full 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.

Enrollment: 33 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Arm I: Control

No Intervention group

Description:

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.

Arm II: Juice

Experimental group

Description:

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

Treatment:

Other: Commercially-available tomato food product

Arm III: Soup

Experimental group

Description:

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

Treatment:

Other: Commercially-available tomato food product

Arm IV: Sauce

Experimental group

Description:

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

Treatment:

Other: Commercially-available tomato food product