Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Phase 1

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Maximal Plasma Carotenoid Concentration	0 to 48 hours	We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Plasma Half Life of Labeled Carotenoid	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.
Time of Maximal Carotenoid Concentration	0 to 48 hours	We will determine when the maximal carotenoid concentration is achieved in the plasma

Secondary Outcome Measures

Name	Time	Method
Carotenoid Metabolites	Up to 28 days	Study the metabolites produced from the labeled carotenoid in healthy subjects

Locations (1): Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States