Healthy
Conditions
Keywords
tomato, prostate cancer, metabolism
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.
Interventions
OTHERIsotopically 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.
Sponsors
University of Illinois at Chicago
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Half Life of Labeled Carotenoid | 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 | 0 to 48 hours | We will determine the average maximal plasma carotenoid concentration in healthy volunteers |
| Time of Maximal Carotenoid Concentration | 0 to 48 hours | We will determine when the maximal carotenoid concentration is achieved in the plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotenoid Metabolites | Up to 28 days | Study the metabolites produced from the labeled carotenoid in healthy subjects |
Countries
United States
Participant flow
Recruitment details
We completed the first two arms of the study with isotopically labelled lycopene and phytoene, however our funding was exhausted after the second arm and we did not complete the isotopically labelled phytofluene arm.
Participants by arm
| Arm | Count |
|---|---|
| Isotopically Labeled Lycopene 10.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism | 8 |
| Isotopically Labeled Phytoene 3.2 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism | 4 |
| Isotopically Labeled Phytofluene 10 mg of labeled carotenoid with a controlled meal.
Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism | 0 |
| Total | 12 |
Baseline characteristics
| Characteristic | Isotopically Labeled Lycopene | Isotopically Labeled Phytoene | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 4 Participants | 12 Participants |
| Age, Continuous | 24 years old | 27.7 years old | 25.3 years old |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 3 Participants | 10 Participants |
| Region of Enrollment United States | 8 participants | 4 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 4 |
| serious Total, serious adverse events | 0 / 8 | 0 / 4 |
Outcome results
Primary
Maximal Plasma Carotenoid Concentration
We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Time frame: 0 to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isotopically Labeled Lycopene | Maximal Plasma Carotenoid Concentration | 0.14 micromol | Standard Error 0.02 |
| Isotopically Labeled Phytoene | Maximal Plasma Carotenoid Concentration | 0.056 micromol | Standard Error 0.006 |
Primary
Plasma Half Life of Labeled Carotenoid
We will study the half life of isotopically labeled carotenoids.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isotopically Labeled Lycopene | Plasma Half Life of Labeled Carotenoid | 6.2 days | Standard Error 0.3 |
| Isotopically Labeled Phytoene | Plasma Half Life of Labeled Carotenoid | 2.3 days | Standard Error 0.2 |
Primary
Time of Maximal Carotenoid Concentration
We will determine when the maximal carotenoid concentration is achieved in the plasma
Time frame: 0 to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isotopically Labeled Lycopene | Time of Maximal Carotenoid Concentration | 30 hours | Standard Error 6 |
| Isotopically Labeled Phytoene | Time of Maximal Carotenoid Concentration | 19.8 hours | Standard Error 9.2 |
Secondary
Carotenoid Metabolites
Study the metabolites produced from the labeled carotenoid in healthy subjects
Time frame: Up to 28 days
Population: Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites. We have frozen plasma and if funds become available we would consider anlayzing the samples for carotenoid metabolites.