Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Completed · Phase 1/Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01692340

Run by

Ohio State University Comprehensive Cancer Center

People needed

12

Starts

2012-02-01

Expected to finish

2013-11-01

Last updated by the study team

2019-03-26

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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