Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
- 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.
- 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
- 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