HealthyNCT02696473
The Bioavailability of Polyacetylenes From Carrots Study
A study testing Carrot in people with Healthy, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Carrot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Sep 2016
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, BMI between 18.5 and 30
Who cannot join
- Metabolic or gastrointestinal conditions, allergies to carrot or bread, taking any medication that affects metabolism or digestion, smokers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, NE6 5HR
About this study
Official title: Absorption of Naturally Present Compounds in Carrots and Their Appearance in Blood and Other Biofluids After Consumption (The Carrot Study)
Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the consumption of a portion of carrots and whether a difference is seen between a large and small portion.
Read the detailed description
Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample either the night before or the morning of the test session. They will have fasted blood taken before eating a portion of carrots with bread and butter. Further blood samples will be taken at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will be collected up to 48 hours after the carrot dose. They volunteers will attend two test sessions and will be randomised to receive high and low doses of carrot. At least a week will separate testing sessions.
- Conditions
- Healthy
- Being tested
- Carrot
- Keywords
- Bioavailability, Polyacetylenes, Falcarinol, Falcarindiol, Falcarindiol-3-acetate, Carrot, Biological Availability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrotDietary supplement
Also called polyacetylene, falcarinol, falcarindiol, falcarindiol-3-acetate
| Study group | Role | What they receive |
|---|---|---|
| High Carrot Dose | Experimental | The volunteer will eat 250g carrot for breakfast with 2 slices of bread and 10g butter Receives: Dietary Supplement: Carrot |
| Low Carrot Dose | Experimental | The volunteer will eat 100g of carrot for breakfast with 2 slices of bread and 10g butter Receives: Dietary Supplement: Carrot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of polyacetylene in biofluids
The primary outcome will be whether a change in concentration of polyacetylene is seen between baseline and various time points in the biofluids after eating carrots.
Measured: 72 hours
Secondary outcomes (1)
Detection of a difference between doses of polyacetylene in biofluids
The secondary outcome will be whether there is a difference between the high and low dose concentrations of polyacetylenes at various time points after eating carrots.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Sarah Warner, Study director, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696473
- Sponsor's protocol ID
- Carrot_01
- Status last verified
- Dec 2016
- First submitted
- 25 Feb 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorption of Naturally Present Compounds in Carrots and Their Appearance in Blood and Other Biofluids After Consumption (The Carrot Study)
- ClinicalTrials.gov ID
- NCT02696473
- Acronym / sponsor ID
- Carrot_01
- Conditions
- Healthy
- Keywords
- Bioavailability, Polyacetylenes, Falcarinol, Falcarindiol, Falcarindiol-3-acetate, Carrot, Biological Availability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Mar 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.
Polyacetylenes, compounds found naturally in carrots, have shown promising anti-cancer and anti-inflammatory actions in vitro but have not been tested in vivo. To determine whether the polyacetylenes could have an effect in vivo, this study aims to determine whether they are detectible in human biofluids after the consumption of a portion of carrots and whether a difference is seen between a large and small portion.
Detailed description
Volunteers will collect urine samples 24 hours prior to the 'test' day and a stool sample either the night before or the morning of the test session. They will have fasted blood taken before eating a portion of carrots with bread and butter. Further blood samples will be taken at 0.5, 1, 2, 3, 4, 6, 8 and 24 hours. All urine and all stool samples (after 4 hours) will be collected up to 48 hours after the carrot dose. They volunteers will attend two test sessions and will be randomised to receive high and low doses of carrot. At least a week will separate testing sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Carrot Dose | Experimental | Dietary Supplement: CarrotThe volunteer will eat 250g carrot for breakfast with 2 slices of bread and 10g butter |
| Low Carrot Dose | Experimental | Dietary Supplement: CarrotThe volunteer will eat 100g of carrot for breakfast with 2 slices of bread and 10g butter |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults, BMI between 18.5 and 30
Key exclusion criteria (1 listed)
- Metabolic or gastrointestinal conditions, allergies to carrot or bread, taking any medication that affects metabolism or digestion, smokers
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 |
|---|---|---|
| CarrotAlso: polyacetylene, falcarinol, falcarindiol, falcarindiol-3-acetate | Dietary supplement | High Carrot Dose, Low Carrot Dose |
Primary outcome
Detection of polyacetylene in biofluids
Time frame: 72 hours
The primary outcome will be whether a change in concentration of polyacetylene is seen between baseline and various time points in the biofluids after eating carrots.
1 secondary outcome
Detection of a difference between doses of polyacetylene in biofluids
Time frame: 72 hours
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 6 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Sarah Warner study director
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrot in people with Healthy, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 6 Dec 2016. 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 Kingdom. 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?
Detection of polyacetylene in biofluids (time frame: 72 hours). 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 6 Dec 2016.