Clinical trial NCT01692340: Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
Official title: Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: tomato
prostate cancer
metabolism
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2012-09-25
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Plasma Half Life of Labeled Carotenoid
timeFrame: 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.
measure: Maximal Plasma Carotenoid Concentration
timeFrame: 0 to 48 hours
measure: Time of Maximal Carotenoid Concentration
timeFrame: 0 to 48 hours
Secondary outcomes:
measure: Carotenoid Metabolites
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Steven Clinton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Moran NE, Cichon MJ, Riedl KM, Grainger EM, Schwartz SJ, Novotny JA, Erdman JW Jr, Clinton SK. Compartmental and noncompartmental modeling of (1)(3)C-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.