Prostate Biomarkers in Men Consuming Tomato Products

Study Overview
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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.

Official Title
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Prostate Biomarkers in Men Consuming Tomato Products

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Commercially-available tomato food product


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm I: Control<br>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<br>Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day). | Other: Commercially-available tomato food product<br>* Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.<br>|
| Experimental: Arm III: Soup<br>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<br>* Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.<br>|
| Experimental: Arm IV: Sauce<br>Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day). | Other: Commercially-available tomato food product<br>* Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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) | 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) | 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) |