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| Name | Class |
|---|---|
| Schwartz, Steven, PhD | UNKNOWN |
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Prostate Biomarkers in Men Consuming Tomato Products
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Control | No Intervention | 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 | Commercially-available tomato food product: men in this group consumed V8® juice (11-16.5 fl. oz./day). |
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| Arm III: Soup | Experimental | Commercially-available tomato food product: men in this group consumed Campbell's® Tomato Soup (2-2 ¾ cups/day). |
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| Arm IV: Sauce | Experimental | Commercially-available tomato food product: men in this group consumed Prego® spaghetti sauce (5-7 oz./day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercially-available tomato food product | Other | Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day. |
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| 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) |
| 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) |
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Inclusion Criteria: To be included in this study, men must:
Exclusion Criteria: Men may not participate in this if they:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton, MD | The Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center/ We | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |