Absorption, Metabolism and Excretion in Healthy VolunteersNCT06686004
Bioavailability Trial
A study testing Carrots in people with Absorption, Metabolism and Excretion in Healthy Volunteers and Bioavailability and AUC, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Carrot is a unique vegetable owing to the availability of bioactive compounds polyacetylenes (PA) as well as carotenoids present in it. These compounds have been shown to be associated with reduced cancer risk in epidemiological-based studies, and also showed anticancer properties in vitro studies and in vivo in mouse… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption, Metabolism and Excretion in Healthy Volunteers, Bioavailability and AUC
- What is being tested?
- Carrots
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2022to 30 Sep 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 20+ years old.
- Having body mass index (BMI) between ≥18.5 - ≤30 kg/m2.
- Must be willing to eat a portion (100g) of carrot in the test session 1, alongside 2 slices of bread with 10g butter.
- Must be willing to eat a portion (300g) of carrot in the test session 2, alongside 2 slices of bread with 10g butter.
Who cannot join
- Having any metabolic or gastrointestinal conditions.
- Having allergies to carrot or bread or butter.
- Taking any medication that affects metabolism or digestion.
- Smokers.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nutrtition Suite, DMBB Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE2 4HH
About this study
Official title: Investigating the Bioavailability of Bioactive Compounds of Vegetable (carrot) in Human Bio-fluids After Consumption
Carrot is a unique vegetable owing to the availability of bioactive compounds polyacetylenes (PA) as well as carotenoids present in it. These compounds have been shown to be associated with reduced cancer risk in epidemiological-based studies, and also showed anticancer properties in vitro studies and in vivo in mouse and rat models. To investigate whether the PA and carotenoids could have beneficial effects in humans, the present study is designed to determine whether they are detectible in human biofluids after the ingestion of a portion of carrots and whether there is a difference in the magnitude of detection after eating a large (300g) and normal (100g) portion.
Read the detailed description
The occurrence of PA and carotenoids in carrot is not a guaranteed that they have potential health benefits and biological activity in humans, as there is still insufficient knowledge as to whether they can be absorbed in human bio-fluids (blood, urine and faeces) after the food (carrot) is consumed in the literature. The bioavailability of compounds depends upon both the chemical forms and physical structures which enable a certain proportion of such compounds into circulation when introduced into the body and so are able to have an active effect.
The main goal of this trial is to investigate determine the fate of (PAs and carotenoids) found in carrots human plasma, urine and faeces.
To achieve this goal, health adult volunteers will be instructed to restrict their diet (To avoid eating food that contain the compounds of interest) for 48hrs and complete 24hr food diary.
They will fast overnight and collect urine and faecal samples on the morning of the test session. Once they arrive in the research facility, they will have fasted blood taken before eating a portion of carrots (either 100 or 300g) with bread and butter. Further blood samples will be taken at 1, 2, 4, 6, 8 and 24 hours. Urine sample will be collected at 4, 8, 12 and 24hr and up to 48hr after the carrot consumption, and faecal samples will be collected at any time the participants feel bowel movement during the study duration up to 48hr, noting the time when each sample was generated.
The participants will attend two test sessions and will be randomised to receive high (300g) and normal (100g) doses of carrot. The washout period separating the two testing sessions is at least a week.
The specific compounds of interest in this trial include PA (falcarinol, falcarindiol, and falcarindiol 3-acetate), carotenoids (α-carotene, β-carotene and lutein) and their concentrations at various time points after consumption and baseline will be measured using HPLC (for carotenoids) and LC-MS (for PA). The concentrations of the compounds at time points after ingestion will be compared with the baseline and also in relation to, normal and high carrot doses.
- Being tested
- Carrots
- Keywords
- bioavailability, metabolism, carrots, carotenoids, polyacetylenes, Falcarinol, Falcarindiol, Falcarindiol-3-acetate, α-carotene, β-carotene, lutein, absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrotsDietary supplement
Also called PA: falcarinol, falcarindiol, falcarindiol-3-acetate, Carotenoids: α-carotene, β-carotene, lutein
Detection of polyacetylene and carotenoids in human biofluids
| Study group | Role | What they receive |
|---|---|---|
| High dose (300g) carrot with 2 slices of bread and 10g butter | Active comparator | Test Session 2:
The participants will consume the 300g carrots with bread and butter. This is considered a reasonable high enough dose that detection of the compounds must occur. This dose would be compared with the normal dose (100g) to see if there is more absorption of the compound when eaten a hiher dose. Receives: Dietary Supplement: Carrots |
| Experimental: Normal dose (100g) carrot with 2 slices of bread and 10g butter | Active comparator | Test session 1: This is a normal dose (100g) which would be compared with the high dose to see if there dose-dependent effect in the magnitude of absorption.
Test Session 2: All the process as in the test session 1 will be repeated for the 300g dose carrot. Receives: Dietary Supplement: Carrots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption of PA and carotenoids
The primary outcome is testing whether a change in concentration of PA and carotenoids is seen between baseline and various time points in the biofluids after ingesting carrots.
Measured: 48hr
Secondary outcomes (1)
Dose-effect between the absorption of PA and carotenoids from 100g and 300g carrots
This is testing whether there is a difference between the high and low dose concentrations of polyacetylenes at various time points after eating carrots.
Measured: 48hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Aug 2022
- Primary completion10 Aug 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption, Metabolism and Excretion in Healthy VolunteersStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Active comparator: orange carrot 100g or 300g Placebo comparator: baseline - before ingestion
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686004
- Sponsor's protocol ID
- Protocol Carrot-01
- Other IDs
- Not funded
- Status last verified
- Aug 2022
- First submitted
- 3 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Bioavailability of Bioactive Compounds of Vegetable (carrot) in Human Bio-fluids After Consumption
- ClinicalTrials.gov ID
- NCT06686004
- Acronym / sponsor ID
- Protocol Carrot-01
- Keywords
- bioavailability, metabolism, carrots, carotenoids, polyacetylenes, Falcarinol, Falcarindiol, Falcarindiol-3-acetate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Nov 2024 (actual)
- 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.
Carrot is a unique vegetable owing to the availability of bioactive compounds polyacetylenes (PA) as well as carotenoids present in it. These compounds have been shown to be associated with reduced cancer risk in epidemiological-based studies, and also showed anticancer properties in vitro studies and in vivo in mouse and rat models. To investigate whether the PA and carotenoids could have beneficial effects in humans, the present study is designed to determine whether they are detectible in human biofluids after the ingestion of a portion of carrots and whether there is a difference in the magnitude of detection after eating a large (300g) and normal (100g) portion.
Detailed description
The occurrence of PA and carotenoids in carrot is not a guaranteed that they have potential health benefits and biological activity in humans, as there is still insufficient knowledge as to whether they can be absorbed in human bio-fluids (blood, urine and faeces) after the food (carrot) is consumed in the literature. The bioavailability of compounds depends upon both the chemical forms and physical structures which enable a certain proportion of such compounds into circulation when introduced into the body and so are able to have an active effect.
The main goal of this trial is to investigate determine the fate of (PAs and carotenoids) found in carrots human plasma, urine and faeces.
To achieve this goal, health adult volunteers will be instructed to restrict their diet (To avoid eating food that contain the compounds of interest) for 48hrs and complete 24hr food diary.
They will fast overnight and collect urine and faecal samples on the morning of the test session. Once they arrive in the research facility, they will have fasted blood taken before eating a portion of carrots (either 100 or 300g) with bread and butter. Further blood samples will be taken at 1, 2, 4, 6, 8 and 24 hours. Urine sample will be collected at 4, 8, 12 and 24hr and up to 48hr after the carrot consumption, and faecal samples will be collected at any time the participants feel bowel movement during the study duration up to 48hr, noting the time when each sample was generated.
The participants will attend two test sessions and will be randomised to receive high (300g) and normal (100g) doses of carrot. The washout period separating the two testing sessions is at least a week.
The specific compounds of interest in this trial include PA (falcarinol, falcarindiol, and falcarindiol 3-acetate), carotenoids (α-carotene, β-carotene and lutein) and their concentrations at various time points after consumption and baseline will be measured using HPLC (for carotenoids) and LC-MS (for PA). The concentrations of the compounds at time points after ingestion will be compared with the baseline and also in relation to, normal and high carrot doses.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Active comparator: orange carrot 100g or 300g Placebo comparator: baseline - before ingestion
| Arm | Type | Receives |
|---|---|---|
| High dose (300g) carrot with 2 slices of bread and 10g butter | Active comparator | Dietary Supplement: CarrotsTest Session 2: The participants will consume the 300g carrots with bread and butter. This is considered a reasonable high enough dose that detection of the compounds must occur. This dose would be compared with the normal dose (100g) to see if there is more absorption of the compound when eaten a hiher dose. |
| Experimental: Normal dose (100g) carrot with 2 slices of bread and 10g butter | Active comparator | Dietary Supplement: CarrotsTest session 1: This is a normal dose (100g) which would be compared with the high dose to see if there dose-dependent effect in the magnitude of absorption. Test Session 2: All the process as in the test session 1 will be repeated for the 300g dose carrot. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults 20+ years old.
- Having body mass index (BMI) between ≥18.5 - ≤30 kg/m2.
- Must be willing to eat a portion (100g) of carrot in the test session 1, alongside 2 slices of bread with 10g butter.
- Must be willing to eat a portion (300g) of carrot in the test session 2, alongside 2 slices of bread with 10g butter.
Key exclusion criteria (4 listed)
- Having any metabolic or gastrointestinal conditions.
- Having allergies to carrot or bread or butter.
- 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 |
|---|---|---|
| CarrotsAlso: PA: falcarinol, falcarindiol, falcarindiol-3-acetate, Carotenoids: α-carotene, β-carotene, luteinDetection of polyacetylene and carotenoids in human biofluids | Dietary supplement | Experimental: Normal dose (100g) carrot with 2 slices of bread and 10g butter, High dose (300g) carrot with 2 slices of bread and 10g butter |
Primary outcome
Absorption of PA and carotenoids
Time frame: 48hr
The primary outcome is testing whether a change in concentration of PA and carotenoids is seen between baseline and various time points in the biofluids after ingesting carrots.
1 secondary outcome
Dose-effect between the absorption of PA and carotenoids from 100g and 300g carrots
Time frame: 48hr
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 13 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrots in people with Absorption, Metabolism and Excretion in Healthy Volunteers and Bioavailability and AUC, run by Newcastle University 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 4 inclusion and 4 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 13 Nov 2024. 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?
Absorption of PA and carotenoids (time frame: 48hr). 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 13 Nov 2024.