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Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
This study has been completed.
Sponsor:
Ohio State University Comprehensive Cancer Center
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: September 4, 2015
Last verified: September 2015
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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: Open Label Primary Purpose: Prevention |
| Official Title: | Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans. |
Resource links provided by NLM:
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| 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
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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
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:
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) ) |
| Study First Received: | September 20, 2012 |
| Results First Received: | February 10, 2015 |
| Last Updated: | September 4, 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 |
ClinicalTrials.gov processed this record on June 28, 2017