Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Costa Rica, University of Hohenheim
Information provided by (Responsible Party):
Steven Schwartz, Ohio State University
ClinicalTrials.gov Identifier:
NCT01748916
First received: December 3, 2012
Last updated: December 12, 2012
Last verified: December 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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: October 2014
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Costa Rica, University of Hohenheim
Investigators
Principal Investigator: Steven J Schwartz, Ph.D. Ohio State University
  More Information

No publications provided

Responsible Party: Steven Schwartz, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01748916     History of Changes
Other Study ID Numbers: 2011H0336
Study First Received: December 3, 2012
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board
Costa Rica: Ethics Committee

Keywords provided by Ohio State University:
Papaya
Carrot
Tomato
Carotenoids
Lycopene
Beta-carotene
Beta-cryptoxanthin

Additional relevant MeSH terms:
Carotenoids
Cryptoxanthin
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014