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Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.

Phase 1/Phase 2
21 Years
70 Years
Open (Enrolling)

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Trial Information

Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Plasma labeled carotenoids

Outcome Description:

We will study the absorption of an isotopically labeled carotenoid.

Outcome Time Frame:

Up to 28 days

Safety Issue:


Principal Investigator

Steven Clinton, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Health
  • tomato
  • prostate cancer
  • metabolism



Ohio State University Medical CenterColumbus, Ohio  43210