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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03180 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isotopically labeled lycopene | Experimental | 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. |
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| Isotopically labeled phytoene | Experimental | 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. |
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| Isotopically labeled phytofluene | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotopically labeled lycopene, phytoene or phytofluene | Other | We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Half Life of Labeled Carotenoid | We will study the half life of isotopically labeled carotenoids. | 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. |
| Maximal Plasma Carotenoid Concentration | We will determine the average maximal plasma carotenoid concentration in healthy volunteers | 0 to 48 hours |
| Time of Maximal Carotenoid Concentration | We will determine when the maximal carotenoid concentration is achieved in the plasma | 0 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Carotenoid Metabolites | Study the metabolites produced from the labeled carotenoid in healthy subjects | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26674763 | Derived | 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. | |
| 26561629 | Derived | 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. |
| Label | URL |
|---|---|
| Jamesline | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Istotopically 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Healthy subjects (6 males and 6 females) between the age of 21-33 yo (inclusive).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Isotopically Labeled Phytoene |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Half Life of Labeled Carotenoid | We will study the half life of isotopically labeled carotenoids. | Posted | Mean | Standard Error | days | 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. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven K. Clinton, MD PhD | The Ohio State University | 614-293-2886 | steven.clinton@osumc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C100185 | (all-E) phytoene |
| C003140 | phytofluene |
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3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years old |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Carotenoid Metabolites | Study the metabolites produced from the labeled carotenoid in healthy subjects | 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. | Posted | Up to 28 days |
|
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| Primary | Maximal Plasma Carotenoid Concentration | We will determine the average maximal plasma carotenoid concentration in healthy volunteers | Posted | Mean | Standard Error | micromol | 0 to 48 hours |
|
|
|
| Primary | Time of Maximal Carotenoid Concentration | We will determine when the maximal carotenoid concentration is achieved in the plasma | Posted | Mean | Standard Error | hours | 0 to 48 hours |
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| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | 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 | 0 | 4 | 0 | 4 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |