Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans - Full Text View

Purpose

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	Intervention	Phase
Healthy	Other: Isotopically labeled lycopene, phytoene or phytofluene	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.

Resource links provided by NLM:

Drug Information available for: Lycopene

U.S. FDA Resources

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
We will study the half life of isotopically labeled carotenoids.
Maximal Plasma Carotenoid Concentration [ Time Frame: 0 to 48 hours ] [ Designated as safety issue: No ]
We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Time of Maximal Carotenoid Concentration [ Time Frame: 0 to 48 hours ] [ Designated as safety issue: No ]
We will determine when the maximal carotenoid concentration is achieved in the plasma

Secondary Outcome Measures:

Carotenoid Metabolites [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Study the metabolites produced from the labeled carotenoid in healthy subjects


Enrollment:	12
Study Start Date:	February 2012
Study Completion Date:	November 2013
Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	21 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692340

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

Additional Information:

Jamesline

This link exits the ClinicalTrials.gov site

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
Study First Received:	September 20, 2012
Results First Received:	February 10, 2015
Last Updated:	September 4, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016