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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02927899
Other study ID # OSU-15064
Secondary ID NCI-2016-01252P3
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2015
Est. completion date April 15, 2015

Study information

Verified date August 2019
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 15, 2015
Est. primary completion date April 15, 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey Administration
Ancillary studies
Dietary Supplement:
Tomato-Soy Juice
Receive tomato-soy beverages with or without varying levels of arugula seed powder

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 2 years
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