Prostate CarcinomaNCT02927899
Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer
A study testing Survey Administration and Tomato-Soy Juice in people with Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Survey Administration and Tomato-Soy Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2015to 15 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Acceptability in the Taste of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Survey Administration, Tomato-Soy Juice
- Keywords
- Tomato-Soy-Arugula
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Ancillary studies
Tomato-Soy JuiceDietary supplement
Receive tomato-soy beverages with or without varying levels of arugula seed powder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey Administration; Dietary Supplement: Tomato-Soy Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study start15 Apr 2015
- Primary completion15 Apr 2015
- Study completion15 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927899
- Sponsor's protocol ID
- OSU-15064
- Other IDs
- NCI-2016-01252, P30CA016058
- Status last verified
- Aug 2019
- First submitted
- 6 Oct 2016
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability in the Taste of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT02927899
- Acronym / sponsor ID
- OSU-15064
- Conditions
- Prostate Carcinoma
- Keywords
- Tomato-Soy-Arugula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 15 Apr 2015 (actual)
- Study completion
- 15 Apr 2015 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (dietary intervention, survey) | Experimental | Other: Survey Administration, Dietary Supplement: Tomato-Soy JuicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationAncillary studies | Other | Prevention (dietary intervention, survey) |
| Tomato-Soy JuiceReceive tomato-soy beverages with or without varying levels of arugula seed powder | Dietary supplement | Prevention (dietary intervention, survey) |
Primary outcome
Sensory acceptability of tomato-soy-arugula seed beverages assessed by survey
Time frame: Up to 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Clinton, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration and Tomato-Soy Juice in people with Prostate Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory acceptability of tomato-soy-arugula seed beverages assessed by survey (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.