HealthyPhase 1/2NCT01692340
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
A Phase 1/2 study testing Isotopically labeled lycopene, phytoene or phytofluene in people with Healthy, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isotopically labeled lycopene, phytoene or phytofluene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between ages of 21-70 years old.
- Body mass index of between 18 and 27 kg/m2 (inclusive).
- Eastern Cooperative Oncology Group (ECOG)performance status of O.
- Not currently be taking carotenoid supplements
- Have Blood Urea Nitrogen (BUN)/Creatinine (CR), liver enzymes, Complete Blood Count (CBC), and Prothrombin time (PT/PTT/INR) within normal limits.
- Have a hemoglobin level of at least 11 g /dL at the time of randomization.
- Voluntarily agree to participate and sign an informed consent document.
Who cannot join
- Have a known allergy or intolerance to tomatoes.
- Have a history of a nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations.
- Have uncontrolled hyperlipidemia (total cholesterol > 200 mg/dL, LDL > 160 mg/dL and serum triglycerides > 200 mg/dL) or lipidemia that may influence carotenoid pharmacokinetics or transport.
- Smoke tobacco products
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
- Are taking certain medications (prescription or over-the-counter) such as Orlistat, which interfere with dietary fat absorption.
- Are taking complementary and alternative medications that at the discretion of the study physician Steven K. Clinton(SKC) may interfere with carotenoid absorption or metabolism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.
- Conditions
- Healthy
- Being tested
- Isotopically labeled lycopene, phytoene or phytofluene
- Keywords
- tomato, prostate cancer, metabolism
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotopically labeled lycopene, phytoene or phytoflueneOther
We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.
| Study group | Role | What they receive |
|---|---|---|
| Isotopically labeled lycopene | Experimental | We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. Receives: Other: Isotopically labeled lycopene, phytoene or phytofluene |
| Isotopically labeled phytoene | Experimental | We will administer 3.2 mg isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. Receives: Other: Isotopically labeled lycopene, phytoene or phytofluene |
| Isotopically labeled phytofluene | Experimental | We will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. Receives: Other: Isotopically labeled lycopene, phytoene or phytofluene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Half Life of Labeled Carotenoid
We will study the half life of isotopically labeled carotenoids.
Measured: labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.
Maximal Plasma Carotenoid Concentration
We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Measured: 0 to 48 hours
Time of Maximal Carotenoid Concentration
We will determine when the maximal carotenoid concentration is achieved in the plasma
Measured: 0 to 48 hours
Secondary outcomes (1)
Carotenoid Metabolites
Study the metabolites produced from the labeled carotenoid in healthy subjects
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692340
- Sponsor's protocol ID
- OSU-09105
- Other IDs
- NCI-2011-03180
- Status last verified
- Mar 2019
- First submitted
- 20 Sep 2012
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moran NE, Novotny JA, Cichon MJ, Riedl KM, Rogers RB, Grainger EM, Schwartz SJ, Erdman JW Jr, Clinton SK. Absorption and Distribution Kinetics of the 13C-Labeled Tomato Carotenoid Phytoene in Healthy Adults. J Nutr. 2016 Feb;146(2):368-76. doi: 10.3945/jn.115.220525. Epub 2015 Dec 16.
PubMed 26674763Moran NE, Cichon MJ, Riedl KM, Grainger EM, Schwartz SJ, Novotny JA, Erdman JW Jr, Clinton SK. Compartmental and noncompartmental modeling of (1)(3)C-lycopene absorption, isomerization, and distribution kinetics in healthy adults. Am J Clin Nutr. 2015 Dec;102(6):1436-49. doi: 10.3945/ajcn.114.103143. Epub 2015 Nov 11.
PubMed 26561629
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
- ClinicalTrials.gov ID
- NCT01692340
- Acronym / sponsor ID
- OSU-09105
- Conditions
- Healthy
- Keywords
- tomato, prostate cancer, metabolism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 7 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isotopically labeled lycopene | Experimental | Other: Isotopically labeled lycopene, phytoene or phytoflueneWe will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. |
| Isotopically labeled phytoene | Experimental | Other: Isotopically labeled lycopene, phytoene or phytoflueneWe will administer 3.2 mg isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. |
| Isotopically labeled phytofluene | Experimental | Other: Isotopically labeled lycopene, phytoene or phytoflueneWe will administer 10 mg of isotopically labeled lycopene, phytoene or phytofluene mixed with olive oil and spread on an English muffin for consumption by participants. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between ages of 21-70 years old.
- Body mass index of between 18 and 27 kg/m2 (inclusive).
- Eastern Cooperative Oncology Group (ECOG)performance status of O.
- Not currently be taking carotenoid supplements
- Have Blood Urea Nitrogen (BUN)/Creatinine (CR), liver enzymes, Complete Blood Count (CBC), and Prothrombin time (PT/PTT/INR) within normal limits.
Key exclusion criteria (7 listed)
- Have a known allergy or intolerance to tomatoes.
- Have a history of a nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations.
- Have uncontrolled hyperlipidemia (total cholesterol > 200 mg/dL, LDL > 160 mg/dL and serum triglycerides > 200 mg/dL) or lipidemia that may influence carotenoid pharmacokinetics or transport.
- Smoke tobacco products
- Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis.
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 |
|---|---|---|
| Isotopically labeled lycopene, phytoene or phytoflueneWe will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants. | Other | Isotopically labeled lycopene, Isotopically labeled phytoene, Isotopically labeled phytofluene |
Primary outcome
Plasma Half Life of Labeled Carotenoid
Time frame: labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.
We will study the half life of isotopically labeled carotenoids.
Maximal Plasma Carotenoid Concentration
Time frame: 0 to 48 hours
We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Time of Maximal Carotenoid Concentration
Time frame: 0 to 48 hours
We will determine when the maximal carotenoid concentration is achieved in the plasma
1 secondary outcome
Carotenoid Metabolites
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26674763Moran NE, Novotny JA, Cichon MJ, Riedl KM, Rogers RB, Grainger EM, Schwartz SJ, Erdman JW Jr, Clinton SK. Absorption and Distribution Kinetics of the 13C-Labeled Tomato Carotenoid Phytoene in Healthy Adults. J Nutr. 2016 Feb;146(2):368-76. doi: 10.3945/jn.115.220525. Epub 2015 Dec 16.
- Derived from this study: PubMed 26561629Moran NE, Cichon MJ, Riedl KM, Grainger EM, Schwartz SJ, Novotny JA, Erdman JW Jr, Clinton SK. Compartmental and noncompartmental modeling of (1)(3)C-lycopene absorption, isomerization, and distribution kinetics in healthy adults. Am J Clin Nutr. 2015 Dec;102(6):1436-49. doi: 10.3945/ajcn.114.103143. Epub 2015 Nov 11.
- 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, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Isotopically labeled lycopene, phytoene or phytofluene in people with Healthy, 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 7 inclusion and 7 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 26 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Half Life of Labeled Carotenoid (time frame: labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692340, which also lists 2 linked publications.
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 26 Mar 2019.