Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Other: Isotopically labeled lycopene, phytoene or phytofluene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotopically labeled lycopene<br>We 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. | Other: Isotopically labeled lycopene, phytoene or phytofluene<br>* We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.<br>|
| Experimental: Isotopically labeled phytoene<br>We 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. | Other: Isotopically labeled lycopene, phytoene or phytofluene<br>* We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.<br>|
| Experimental: Isotopically labeled phytofluene<br>We 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. | Other: Isotopically labeled lycopene, phytoene or phytofluene<br>* We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotenoid Metabolites | Study the metabolites produced from the labeled carotenoid in healthy subjects | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tomato, prostate cancer, metabolism