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
  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:
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
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014