Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

This study has been completed.

Sponsor:

Collaborator:

University of Illinois at Chicago

Information provided by (Responsible Party):

Steven Clinton, Ohio State University Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01692340

First received: September 20, 2012

Last updated: December 19, 2013

Last verified: December 2013

History of Changes

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: Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	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.

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

Primary Outcome Measures:

Plasma labeled carotenoids [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
We will study the absorption of an isotopically labeled carotenoid.

Secondary Outcome Measures:

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


Enrollment:	11
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 10 mg of labeled carotenoid with a controlled meal.	Other: Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Experimental: Isotopically labeled phytoene 10 mg of labeled carotenoid with a controlled meal.	Other: Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Experimental: Isotopically labeled phytofluene 10 mg of labeled carotenoid with a controlled meal.	Other: Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism

Eligibility


Ages Eligible for Study:	21 Years to 70 Years
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

No publications provided


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
Last Updated:	December 19, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:


tomato prostate cancer metabolism

Additional relevant MeSH terms:


Carotenoids Antioxidants Molecular Mechanisms of Pharmacological Action	Pharmacologic Actions Physiological Effects of Drugs Protective Agents

ClinicalTrials.gov processed this record on February 25, 2015

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