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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01748916
Other study ID # 2011H0336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2011
Est. completion date November 2011

Study information

Verified date July 2021
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Focus of Study: Carotenoid Absorption

Intervention

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.
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.

Locations

Country Name City State
Costa Rica University of Costa Rica San José
United States The Ohio State University Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Universidad de Costa Rica, University of Hohenheim

Countries where clinical trial is conducted

United States,  Costa Rica, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato 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. 8 post-prandial blood samples over 9.5 hours