- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927899
Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer
Acceptability in the Taste of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prevention (dietary intervention, survey)
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.
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Ancillary studies
Receive tomato-soy beverages with or without varying levels of arugula seed powder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory acceptability of tomato-soy-arugula seed beverages assessed by survey
Time Frame: Up to 2 years
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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.
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Up to 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven Clinton, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSU-15064
- P30CA016058 (U.S. NIH Grant/Contract)
- NCI-2016-01252 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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