Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

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.