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Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01748916

First Posted: December 13, 2012

Last Update Posted: June 14, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

University of Hohenheim

University of Costa Rica

Information provided by (Responsible Party):

Jessica Cooperstone, Ohio State University

Purpose

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	Intervention
Focus of Study: Carotenoid Absorption	Other: Papaya Other: Carrot Other: Tomato


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Solanum lycopersicum

U.S. FDA Resources

Further study details as provided by Jessica Cooperstone, Ohio State University:

Primary Outcome Measures:

Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato [ Time Frame: 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.


Enrollment:	16
Study Start Date:	June 2011
Estimated Study Completion Date:	January 2019
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748916

Locations


United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Costa Rica
University of Costa Rica
San José, Costa Rica

Sponsors and Collaborators

Ohio State University

University of Hohenheim

University of Costa Rica

Investigators


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

More Information


Responsible Party:	Jessica Cooperstone, Research Scientist, Ohio State University
ClinicalTrials.gov Identifier:	NCT01748916 History of Changes
Other Study ID Numbers:	2011H0336
First Submitted:	December 3, 2012
First Posted:	December 13, 2012
Results First Submitted:	October 15, 2014
Results First Posted:	October 24, 2014
Last Update Posted:	June 14, 2017
Last Verified:	May 2017

Keywords provided by Jessica Cooperstone, Ohio State University:


Papaya Carrot Tomato Carotenoids	Lycopene Beta-carotene Beta-cryptoxanthin

Additional relevant MeSH terms:


Lycopene Carotenoids Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs	Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents Vitamins Micronutrients Growth Substances

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