NCT01748916

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 24, 2014

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

5 months

First QC Date

December 3, 2012

Results QC Date

October 15, 2014

Last Update Submit

October 15, 2025

Conditions

Keywords

PapayaCarrotTomatoCarotenoidsLycopeneBeta-caroteneBeta-cryptoxanthin

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

Papaya-Carrot-Tomato

EXPERIMENTAL

Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.

Other: PapayaOther: CarrotOther: Tomato

Papaya-Tomato-Carrot

EXPERIMENTAL

Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot

Other: PapayaOther: CarrotOther: Tomato

Tomato-Papaya-Carrot

EXPERIMENTAL

Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot

Other: PapayaOther: CarrotOther: Tomato

Tomato-Carrot-Papaya

EXPERIMENTAL

Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya

Other: PapayaOther: CarrotOther: Tomato

Carrot-Papaya-Tomato

EXPERIMENTAL

Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato

Other: PapayaOther: CarrotOther: Tomato

Carrot-Tomato-Papaya

EXPERIMENTAL

Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya

Other: PapayaOther: CarrotOther: Tomato

Interventions

PapayaOTHER

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-Papaya-TomatoCarrot-Tomato-PapayaPapaya-Carrot-TomatoPapaya-Tomato-CarrotTomato-Carrot-PapayaTomato-Papaya-Carrot
CarrotOTHER

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.

Carrot-Papaya-TomatoCarrot-Tomato-PapayaPapaya-Carrot-TomatoPapaya-Tomato-CarrotTomato-Carrot-PapayaTomato-Papaya-Carrot
TomatoOTHER

Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.

Carrot-Papaya-TomatoCarrot-Tomato-PapayaPapaya-Carrot-TomatoPapaya-Tomato-CarrotTomato-Carrot-PapayaTomato-Papaya-Carrot

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Costa Rica

San José, Costa Rica

Location

Results Point of Contact

Title
Dr. Ralf Schweiggert
Organization
University of Hohenheim

Study Officials

  • Steven J Schwartz, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 13, 2012

Study Start

June 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 20, 2025

Results First Posted

October 24, 2014

Record last verified: 2025-10

Locations