Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
2 other identifiers
interventional
12
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2012
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 7, 2015
CompletedMarch 26, 2019
March 1, 2019
1.8 years
September 20, 2012
February 10, 2015
March 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Plasma Half Life of Labeled Carotenoid
We will study the half life of isotopically labeled carotenoids.
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
0 to 48 hours
Time of Maximal Carotenoid Concentration
We will determine when the maximal carotenoid concentration is achieved in the plasma
0 to 48 hours
Secondary Outcomes (1)
Carotenoid Metabolites
Up to 28 days
Study Arms (3)
Isotopically labeled lycopene
EXPERIMENTALWe 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
EXPERIMENTALWe 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
EXPERIMENTALWe 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.
Interventions
We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Publications (2)
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.
PMID: 26674763DERIVEDMoran 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.
PMID: 26561629DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven K. Clinton, MD PhD
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Clinton, MD, PhD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 25, 2012
Study Start
February 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
March 26, 2019
Results First Posted
October 7, 2015
Record last verified: 2019-03