Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Isotopically labeled lycopene, phytoene or phytofluene

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Steven Clinton, MD, PhD, Ohio State University

Publications and helpful links

General Publications

• 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 (1)(3)C-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.

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: September 20, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (ESTIMATE): September 25, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: prostate cancer; metabolism; tomato
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Lycopene
• Other Study ID Numbers: OSU-09105; NCI-2011-03180 (REGISTRY: Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No