CancerNCT01142037
Development of a Biomarker for Dietary Furanocoumarins
A study testing Cooked parsnips with parsley in people with Cancer and Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Cooked parsnips with parsley
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2011
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Healthy
Who cannot join
- History of gastrointestinal, hepatic or renal disorder
- Currently taking any prescription or over-the-counter medication
- Currently taking any herbal supplement
- Pregnant or lactating
- Allergies to foods that will be used (parsnips and parsley)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition, University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. This study will develop a urine test to determine if an individual ate foods that contain furanocoumarins.
- Being tested
- Cooked parsnips with parsley
- Keywords
- Healthy volunteer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooked parsnips with parsleyDietary supplement
Beginning on Day 9 participants will be given cooked parsnips with parsley at a dose of 2 grams total apiaceous vegetable/kilogram body weight for period 1, and 4 gram/kilogram body weight for period 2.
| Study group | Role | What they receive |
|---|---|---|
| Furanocoumarin | Experimental | Includes participants first refraining from eating foods with furanocoumarins for one week, followed by 2 weeks of increasing furanocoumarin consumption. Participants will be asked to consume cooked parsnips and parsley. Receives: Dietary Supplement: Cooked parsnips with parsley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Biomarker Results for Dietary Furanocoumarins
determine the optimal conditions for furanocoumarin identification and quantification in human urine
Measured: Week 1
Secondary outcomes (1)
Mean Concentration of Dietary Furanocoumarin in Urine
Determine dose response of dietary furanocoumarin in urine - Comparison of Pre-Dose, Low-Dose and High Dose diet of furanocoumarin in subjects' urine collected (ng/ml).
Measured: Week 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sabrina Peterson, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142037
- Sponsor's protocol ID
- 2009NTLS107
- Other IDs
- 0909M72358, 1K07CA128952-01A2
- Status last verified
- Aug 2014
- First submitted
- 9 Jun 2010
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biomarker for Dietary Furanocoumarins
- ClinicalTrials.gov ID
- NCT01142037
- Acronym / sponsor ID
- 2009NTLS107
- Keywords
- Healthy volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Jun 2010 (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.
Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. This study will develop a urine test to determine if an individual ate foods that contain furanocoumarins.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furanocoumarin | Experimental | Dietary Supplement: Cooked parsnips with parsleyIncludes participants first refraining from eating foods with furanocoumarins for one week, followed by 2 weeks of increasing furanocoumarin consumption. Participants will be asked to consume cooked parsnips and parsley. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be at least 18 years of age
- Healthy
Key exclusion criteria (5 listed)
- History of gastrointestinal, hepatic or renal disorder
- Currently taking any prescription or over-the-counter medication
- Currently taking any herbal supplement
- Pregnant or lactating
- Allergies to foods that will be used (parsnips and parsley)
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 |
|---|---|---|
| Cooked parsnips with parsleyBeginning on Day 9 participants will be given cooked parsnips with parsley at a dose of 2 grams total apiaceous vegetable/kilogram body weight for period 1, and 4 gram/kilogram body weight for period 2. | Dietary supplement | Furanocoumarin |
Primary outcome
Urinary Biomarker Results for Dietary Furanocoumarins
Time frame: Week 1
determine the optimal conditions for furanocoumarin identification and quantification in human urine
1 secondary outcome
Mean Concentration of Dietary Furanocoumarin in Urine
Time frame: Week 1, 2 and 3
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 22 Aug 2014.
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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.
Sabrina Peterson, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooked parsnips with parsley in people with Cancer and Healthy, run by University of Minnesota 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 2 inclusion and 5 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 22 Aug 2014. 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?
Urinary Biomarker Results for Dietary Furanocoumarins (time frame: Week 1). 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 22 Aug 2014.