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Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer

Primary Purpose

Prostate Carcinoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Survey Administration

Tomato-Soy Juice

About this trial

This is an interventional prevention trial for Prostate Carcinoma focused on measuring Tomato-Soy-Arugula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Have a prostate cancer diagnosis
Not be allergic to tomato or tomato products
Not be allergic to soy or soy related products
Not be allergic to any cruciferous vegetables (e.g.: broccoli, cauliflower, kale, brussels sprouts, arugula/rocket, bok choy, etc.)
Voluntarily agree to participate and read the informed consent documents

Sites / Locations

Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (dietary intervention, survey)

Arm Description

Patients receive 4 tomato-soy beverages and 3 labeled arugula seed powder portions. Patients add 1 arugula seed powder portion to each of 3 tomato-soy beverages immediately prior to consumption, and they consume 1 beverage without the powder. After each beverage tasting, patients complete a survey on the sensory acceptability of the sample.

Outcomes

Primary Outcome Measures

Sensory acceptability of tomato-soy-arugula seed beverages assessed by survey

Mean plus/minus standard deviation will be used to express the results from the acceptability tests and the Just About Right tests. Ranking results will be analyzed by using t-test to obtain determine statistical significance. Significance level of the value will be chosen before statistic tests are conducted, at a value of 5%. A critical value below p < 0.05, will be considered statistically significant.

Secondary Outcome Measures

Full Information

NCT ID

NCT02927899

First Posted

October 6, 2016

Last Updated

August 29, 2019

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02927899

Brief Title

Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer

Official Title

Acceptability in the Taste of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 15, 2015 (Actual)

Primary Completion Date

April 15, 2015 (Actual)

Study Completion Date

April 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a sensory analysis of several different formulations of a novel tomato-soy-arugula seed beverage in men with prostate cancer. Eating a diet rich in a variety of fruits and vegetables has been associated with decreased risk of a variety of diseases, including prostate cancer. Mixed vegetable beverages may be useful in prostate cancer survivorship.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the sensory acceptability of a novel tomato-soy-arugula seed beverage in men with prostate cancer. OUTLINE: Patients receive 4 tomato-soy beverages and 3 labeled arugula seed powder portions. Patients add 1 arugula seed powder portion to each of 3 tomato-soy beverages immediately prior to consumption and they consume 1 beverage without the powder. After each beverage tasting, patients complete a survey on the sensory acceptability of the sample.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma

Keywords

Tomato-Soy-Arugula

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prevention (dietary intervention, survey)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Survey Administration

Intervention Description

Ancillary studies

Intervention Type

Dietary Supplement

Intervention Name(s)

Tomato-Soy Juice

Intervention Description

Receive tomato-soy beverages with or without varying levels of arugula seed powder

Primary Outcome Measure Information:

Title

Sensory acceptability of tomato-soy-arugula seed beverages assessed by survey

Description

Time Frame

Up to 2 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a prostate cancer diagnosis Not be allergic to tomato or tomato products Not be allergic to soy or soy related products Not be allergic to any cruciferous vegetables (e.g.: broccoli, cauliflower, kale, brussels sprouts, arugula/rocket, bok choy, etc.) Voluntarily agree to participate and read the informed consent documents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Clinton, MD

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Comprehensive Cancer Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

The Jamesline

Learn more about this trial

Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer

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