Trial Outcomes & Findings for Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans (NCT NCT01692340)

NCT ID: NCT01692340

Last Updated: 2019-03-26

Results Overview

We will study the half life of isotopically labeled carotenoids.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome 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.

Results posted on

2019-03-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	8	4
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Isotopically Labeled Lycopene n=8 Participants 10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	Isotopically Labeled Phytoene n=4 Participants 3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	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	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	—	12 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Age, Continuous	24 years old n=5 Participants	27.7 years old n=7 Participants	—	25.3 years old n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	—	6 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	—	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	—	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	—	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	—	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	4 participants n=7 Participants	—	12 participants n=4 Participants

PRIMARY outcome

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.

We will study the half life of isotopically labeled carotenoids.

Outcome measures

Outcome measures
Measure	Isotopically Labeled Lycopene n=8 Participants 10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	Isotopically Labeled Phytoene n=4 Participants 3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	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
Plasma Half Life of Labeled Carotenoid	6.2 days Standard Error 0.3	2.3 days Standard Error 0.2	—

PRIMARY outcome

Timeframe: 0 to 48 hours

We will determine the average maximal plasma carotenoid concentration in healthy volunteers

Outcome measures

Outcome measures
Measure	Isotopically Labeled Lycopene n=8 Participants 10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	Isotopically Labeled Phytoene n=4 Participants 3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	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
Maximal Plasma Carotenoid Concentration	0.14 micromol Standard Error 0.02	0.056 micromol Standard Error 0.006	—

PRIMARY outcome

Timeframe: 0 to 48 hours

We will determine when the maximal carotenoid concentration is achieved in the plasma

Outcome measures

Outcome measures
Measure	Isotopically Labeled Lycopene n=8 Participants 10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	Isotopically Labeled Phytoene n=4 Participants 3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	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
Time of Maximal Carotenoid Concentration	30 hours Standard Error 6	19.8 hours Standard Error 9.2	—

SECONDARY outcome

Timeframe: 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.

Study the metabolites produced from the labeled carotenoid in healthy subjects

Outcome measures

Outcome data not reported

Adverse Events

Isotopically Labeled Lycopene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Isotopically Labeled Phytoene

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven K. Clinton, MD PhD

The Ohio State University

Phone: 614-293-2886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place