Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Other: Isotopically labeled lycopene, phytoene or phytofluene	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
Study Start Date :	February 2012
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	November 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

Outcome Measures

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Primary Outcome Measures :

1. Plasma Half Life of Labeled Carotenoid [ Time Frame: 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. ]
   We will study the half life of isotopically labeled carotenoids.
2. Maximal Plasma Carotenoid Concentration [ Time Frame: 0 to 48 hours ]
   We will determine the average maximal plasma carotenoid concentration in healthy volunteers
3. Time of Maximal Carotenoid Concentration [ Time Frame: 0 to 48 hours ]
   We will determine when the maximal carotenoid concentration is achieved in the plasma

Secondary Outcome Measures :

1. Carotenoid Metabolites [ Time Frame: Up to 28 days ]
   Study the metabolites produced from the labeled carotenoid in healthy subjects

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

University of Illinois at Chicago

Investigators

Principal Investigator:	Steven Clinton, MD, PhD	Ohio State University

More Information

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Additional Information:

Jamesline 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moran NE, Novotny JA, Cichon MJ, Riedl KM, Rogers RB, Grainger EM, Schwartz SJ, Erdman JW Jr, Clinton SK. Absorption and Distribution Kinetics of the 13C-Labeled Tomato Carotenoid Phytoene in Healthy Adults. J Nutr. 2016 Feb;146(2):368-76. doi: 10.3945/jn.115.220525. Epub 2015 Dec 16.

Moran NE, Cichon MJ, Riedl KM, Grainger EM, Schwartz SJ, Novotny JA, Erdman JW Jr, Clinton SK. Compartmental and noncompartmental modeling of ¹³C-lycopene absorption, isomerization, and distribution kinetics in healthy adults. Am J Clin Nutr. 2015 Dec;102(6):1436-49. doi: 10.3945/ajcn.114.103143. Epub 2015 Nov 11.

Responsible Party:	Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01692340 History of Changes
Other Study ID Numbers:	OSU-09105; NCI-2011-03180 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted:	September 25, 2012
Results First Posted:	October 7, 2015
Last Update Posted:	January 23, 2018
Last Verified:	December 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:

tomato; prostate cancer; metabolism

Additional relevant MeSH terms:

Lycopene; Carotenoids; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents	Physiological Effects of Drugs; Radiation-Protective Agents; Anticarcinogenic Agents; Antineoplastic Agents