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Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692340
First Posted: September 25, 2012
Last Update Posted: October 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center
  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
Intervention Model: Single Group Assignment
Masking: None (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 Steven Clinton, 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. ]
    We will study the half life of isotopically labeled carotenoids.

  • Maximal Plasma Carotenoid Concentration [ Time Frame: 0 to 48 hours ]
    We will determine the average maximal plasma carotenoid concentration in healthy volunteers

  • 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:
  • Carotenoid Metabolites [ Time Frame: Up to 28 days ]
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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):

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 Submitted: September 20, 2012
First Posted: September 25, 2012
Results First Submitted: February 10, 2015
Results First Posted: October 7, 2015
Last Update Posted: October 7, 2015
Last Verified: September 2015

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