Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-11-30

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Isotopically labeled lycopene

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.

Group Type EXPERIMENTAL

Isotopically labeled lycopene, phytoene or phytofluene

Intervention Type OTHER

We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.

Isotopically labeled phytoene

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.

Group Type EXPERIMENTAL

Isotopically labeled lycopene, phytoene or phytofluene

Intervention Type OTHER

We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.

Isotopically labeled phytofluene

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.

Group Type EXPERIMENTAL

Isotopically labeled lycopene, phytoene or phytofluene

Intervention Type OTHER

We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.

Interventions

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Isotopically labeled lycopene, phytoene or phytofluene

We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.

Intervention Type OTHER

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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes