Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

The Ohio State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Other: Isotopically labeled lycopene, phytoene or phytofluene

Study type: Interventional

Funder types: Other

Identifiers

NCT01692340

OSU-09105

NCI-2011-03180 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Isotopically labeled lycopene

Experimental group

Description:

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.

Treatment:

Other: Isotopically labeled lycopene, phytoene or phytofluene

Isotopically labeled phytoene

Experimental group

Description:

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.

Treatment:

Other: Isotopically labeled lycopene, phytoene or phytofluene

Isotopically labeled phytofluene

Experimental group

Description:

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.

Treatment:

Other: Isotopically labeled lycopene, phytoene or phytofluene