Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01748916
• Collaborator: University of Hohenheim (Other), Universidad de Costa Rica (Other)
• Enrollment: 16
• Locations: 2
• Arms: 6
• Duration (Months): 5
• Patients Per Site: 8
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The goal of this study is to determine if papaya fruits are an exceptionally good food source for carotenoids in humans, particularly when compared more common carotenoid sources like carrots and tomatoes. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from subjects who consumed a meal containing fresh papaya, tomato, and carrot.

Condition or Disease	Intervention/Treatment	Phase
Focus of Study: Carotenoid Absorption	Other: Papaya; Other: Carrot; Other: Tomato	N/A

Detailed Description

The main purpose of this study is comparing bioavailability of papaya carotenoids versus carrot and tomato carotenoids. Previously, vitamin A deposition in rat livers was studied, showing that carotenoid bioavailability from papaya is higher than from spinach, parsley and carrots. Detailed knowledge about human carotenoid absorption and conversion from papaya fruit compared to other food sources is still lacking.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of the Effect of the Consumption of Papaya, Tomato, and Carrot on the Bioavailability of Carotenoids
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Papaya-Carrot-Tomato Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Experimental: Papaya-Tomato-Carrot Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Experimental: Tomato-Papaya-Carrot Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Experimental: Tomato-Carrot-Papaya Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Experimental: Carrot-Papaya-Tomato Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Experimental: Carrot-Tomato-Papaya Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya	Other: Papaya; Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Carrot; Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.; Other: Tomato; Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato [8 post-prandial blood samples over 9.5 hours]

   The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy individuals

Exclusion Criteria:

• lactating, pregnant, or planned to be pregnant

• smokers/those who use tobacco products

• metabolic or malabsorption disorders

• had a history of cancer

• history of liver insufficiency or other gastro-intestinal diseases

• allergy to papaya, carrots or tomatoes

• obesity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210
2	University of Costa Rica	San José		Costa Rica

Sponsors and Collaborators

• Ohio State University
• University of Hohenheim
• Universidad de Costa Rica

Investigators

• Principal Investigator: Steven J Schwartz, Ph.D., Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Cooperstone, Research Scientist, Ohio State University
• ClinicalTrials.gov Identifier: NCT01748916
• Other Study ID Numbers: 2011H0336
• First Posted: Dec 13, 2012
• Last Update Posted: Jul 9, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Jessica Cooperstone, Research Scientist, Ohio State University: Papaya; Carrot; Tomato; Carotenoids; Lycopene; Beta-carotene; Beta-cryptoxanthin

Study Results

Participant Flow

Recruitment Details	Recruitment was carried out at the University of Costa Rica during June 2011 - August 2011.
Pre-assignment Detail	Sixteen healthy, non-pregnant, non-smoking participants (21-44 y) were enrolled after checking eligibility, which was based on a questionnaire. Exclusion criteria included any history of chronic gastrointestinal disease, use of medications affecting lipid metabolism, regular use of carotenoid-containing supplements and frequent alcohol consumption.

Arm/Group Title	Papaya-Carrot-Tomato	Papaya-Tomato-Carrot	Tomato-Papaya-Carrot	Tomato-Carrot-Papaya	Carrot-Papaya-Tomato	Carrot-Tomato-Papaya
Arm/Group Description	Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato. Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.	Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.	Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.	Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.	Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.	Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread. Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread. Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
Period Title: Overall Study
STARTED	2	3	2	3	3	3
COMPLETED	2	3	2	3	3	3
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Groups (Average)
Arm/Group Description	All study participants
Overall Participants	16
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	27
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	10 62.5%
Male	6 37.5%
Region of Enrollment (participants) [Number]
Costa Rica	16 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato
Description	The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.
Time Frame	8 post-prandial blood samples over 9.5 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Beta-Carotene Absorption From Papaya	Beta-Carotene Absorption From Tomato	Beta-Carotene Absorption From Carrot	Lycopene Absorption From Papaya	Lycopene Absorption From Tomato
Arm/Group Description
Measure Participants	16	16	16	16	16
Median (Inter-Quartile Range) [nmol*h/L]	163	62	64	174	58

Adverse Events

Arm/Group Title	All Groups
Arm/Group Description	All groups in study
All Cause Mortality
	All Groups
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Groups
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	All Groups
	Affected / at Risk (%)	# Events
Total	0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.