Clinical trial · Interventional
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isotopically labeled lycopene, phytoene or phytofluene | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Isotopically labeled lycopene
- description
- 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.
- interventionNames
- Other: Isotopically labeled lycopene, phytoene or phytofluene
- type
- EXPERIMENTAL
- label
- Isotopically labeled phytoene
- description
- 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.
- interventionNames
- Other: Isotopically labeled lycopene, phytoene or phytofluene
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDMoran 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. PMID 26674763
- DERIVEDMoran 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. PMID 26561629