NCT01432210

Brief Summary

Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and vegetables is not "active" and must be converted to the active form in the human body. However, information on the ability of humans to absorb and convert vitamin A to the active form is still lacking. In this study, the investigators will observe the absorption and conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from avocado fruit) and a meal without fat. The investigators will also test whether eating these foods might protect the blood against damage that could lead to heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

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

September 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 4, 2011

Last Update Submit

September 28, 2016

Conditions

Keywords

post-prandial absorptionprovitamin A carotenoidsvitamin Aavocadotomatocarrot

Outcome Measures

Primary Outcomes (1)

  • Post-prandial levels of provitamin A and vitamin A

    The absorption of and conversion of provitamin A carotenoids into vitamin A will be measured after the consumption of a carotenoid-rich meal. The meal will be served both with and without avocado as a source of lipid.

    Nine post-prandial blood samples will be taken over twelve hours

Secondary Outcomes (1)

  • post-prandial antioxidant status of blood

    comparing baseline vs. 5 hour status

Study Arms (2)

Tomato Meal

OTHER

A tomato meal will be fed with and without avocado.

Other: Post-prandial Feeding Study

Carrot Meal

OTHER

A carrot meal will be fed with and without avocado.

Other: Post-prandial Feeding Study

Interventions

Carrot MealTomato Meal

Eligibility Criteria

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

You may qualify if:

  • Total cholesterol (140 to 200 mg/dL)
  • BMI 17 to 30
  • Age 18-70 years

You may not qualify if:

  • Lactating, pregnant, or plan to be pregnant during study
  • Tobacco use (cigarettes or chewing tobacco)
  • Metabolic disease
  • Malabsorption disorders
  • History of cancer, esophageal, gastric, or intestinal ulcers
  • History of liver or kidney insufficiency or failure
  • Allergies to tomatoes or tomato products
  • Allergies to carrots
  • Allergies to avocados
  • Obesity (BMI\>30)
  • Hypercholesterolemia (total cholesterol\> 200mg/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Clinical Research Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • Cooperstone JL, Goetz HJ, Riedl KM, Harrison EH, Schwartz SJ, Kopec RE. Relative contribution of alpha-carotene to postprandial vitamin A concentrations in healthy humans after carrot consumption. Am J Clin Nutr. 2017 Jul;106(1):59-66. doi: 10.3945/ajcn.116.150821. Epub 2017 May 17.

  • Kopec RE, Cooperstone JL, Schweiggert RM, Young GS, Harrison EH, Francis DM, Clinton SK, Schwartz SJ. Avocado consumption enhances human postprandial provitamin A absorption and conversion from a novel high-beta-carotene tomato sauce and from carrots. J Nutr. 2014 Aug;144(8):1158-66. doi: 10.3945/jn.113.187674. Epub 2014 Jun 4.

Study Officials

  • Steven J Schwartz, Ph.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

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

September 4, 2011

First Posted

September 12, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations