NCT02927899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

Same day

First QC Date

October 6, 2016

Last Update Submit

August 29, 2019

Conditions

Keywords

Tomato-Soy-Arugula

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Prevention (dietary intervention, survey)

EXPERIMENTAL

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.

Other: Survey AdministrationDietary Supplement: Tomato-Soy Juice

Interventions

Ancillary studies

Prevention (dietary intervention, survey)
Tomato-Soy JuiceDIETARY_SUPPLEMENT

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

Prevention (dietary intervention, survey)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Steven Clinton, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2016

First Posted

October 7, 2016

Study Start

April 15, 2015

Primary Completion

April 15, 2015

Study Completion

April 15, 2015

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations