Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01692340
• Collaborator: University of Illinois at Chicago (Other)
• Enrollment: 12
• Location: 1
• Arms: 3
• Duration (Months): 21
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Isotopically labeled lycopene, phytoene or phytofluene	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans.
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isotopically labeled lycopene 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.	Other: Isotopically 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.
Experimental: Isotopically labeled phytoene 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.	Other: Isotopically 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.
Experimental: Isotopically labeled phytofluene 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.	Other: Isotopically 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Maximal Plasma Carotenoid Concentration [0 to 48 hours]

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

3. Time of Maximal Carotenoid Concentration [0 to 48 hours]

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

Secondary Outcome Measures

1. Carotenoid Metabolites [Up to 28 days]

   Study the metabolites produced from the labeled carotenoid in healthy subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center
• University of Illinois at Chicago

Investigators

• Principal Investigator: Steven Clinton, MD, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Jamesline

Publications

None provided.

• Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01692340
• Other Study ID Numbers: OSU-09105; NCI-2011-03180
• First Posted: Sep 25, 2012
• Last Update Posted: Mar 26, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center: tomato; prostate cancer; metabolism
• Additional relevant MeSH terms: Lycopene

Study Results

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.

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene	Istotopically Labeled Phytofluene
Arm/Group Description	10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Period Title: Overall Study
STARTED	8	4	0
COMPLETED	8	4	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene	Isotopically Labeled Phytofluene	Total
Arm/Group Description	10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	Total of all reporting groups
Overall Participants	8	4	0	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 NaN
Between 18 and 65 years	8 100%	4 100%	12 Infinity
>=65 years	0 0%	0 0%	0 NaN
Age (years old) [Mean (Full Range) ]
Mean (Full Range) [years old]	24	27.7	25.3
Sex: Female, Male (Count of Participants)
Female	4 50%	2 50%	6 Infinity
Male	4 50%	2 50%	6 Infinity
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 NaN
Asian	1 12.5%	1 25%	2 Infinity
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 NaN
Black or African American	0 0%	0 0%	0 NaN
White	7 87.5%	3 75%	10 Infinity
More than one race	0 0%	0 0%	0 NaN
Unknown or Not Reported	0 0%	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	8 100%	4 100%	12 Infinity

Outcome Measures

1. Primary Outcome

Title	Plasma Half Life of Labeled Carotenoid
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene
Arm/Group Description	10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Measure Participants	8	4
Mean (Standard Error) [days]	6.2 (0.3)	2.3 (0.2)

2. Secondary Outcome

Title	Carotenoid Metabolites
Description	Study the metabolites produced from the labeled carotenoid in healthy subjects
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene
Arm/Group Description	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Measure Participants	0	0

3. Primary Outcome

Title	Maximal Plasma Carotenoid Concentration
Description	We will determine the average maximal plasma carotenoid concentration in healthy volunteers
Time Frame	0 to 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene
Arm/Group Description	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Measure Participants	8	4
Mean (Standard Error) [micromol]	0.14 (0.02)	0.056 (0.006)

4. Primary Outcome

Title	Time of Maximal Carotenoid Concentration
Description	We will determine when the maximal carotenoid concentration is achieved in the plasma
Time Frame	0 to 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isotopically Labeled Lycopene	Isotopically Labeled Phytoene	Isotopically Labeled Phytofluene
Arm/Group Description	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism	10 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
Measure Participants	8	4	0
Mean (Standard Error) [hours]	30 (6)	19.8 (9.2)

Adverse Events

Arm/Group Title	Isotopically Labeled Lycopene		Isotopically Labeled Phytoene
Arm/Group Description	10.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism		3.2 mg of labeled carotenoid with a controlled meal. Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism
All Cause Mortality
	Isotopically Labeled Lycopene		Isotopically Labeled Phytoene
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Isotopically Labeled Lycopene		Isotopically Labeled Phytoene
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Isotopically Labeled Lycopene		Isotopically Labeled Phytoene
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.