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Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot

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ClinicalTrials.gov Identifier: NCT01748916
Recruitment Status : Active, not recruiting
First Posted : December 13, 2012
Results First Posted : October 24, 2014
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
University of Hohenheim
University of Costa Rica
Information provided by (Responsible Party):
Jessica Cooperstone, Ohio State University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
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 : June 2011
Actual Primary Completion Date : November 2011
Estimated Study Completion Date : January 2019

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jessica Cooperstone, Research Scientist, Ohio State University
ClinicalTrials.gov Identifier: NCT01748916     History of Changes
Other Study ID Numbers: 2011H0336
First Posted: December 13, 2012    Key Record Dates
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
Beta-Cryptoxanthin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
 Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Provitamins
Vitamins
Micronutrients
Growth Substances