Provitamin A Absorption and Conversion With Avocados

NCT ID: NCT01432210

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this study will be to demonstrate that adding avocados to a carotene rich meal will promote the absorption of provitamin A carotenoids and enhance the delivery of greater quantities of vitamin A. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites after subjects consume a meal with or without avocado in combination with a serving of tomato sauce (containing nutritionally relevant amounts of beta-carotene) or carrots.

The secondary objective of this study will be to determine if higher levels of carotenoids and other antioxidants transported in the bloodstream will have a protective role in promoting cardiovascular health. This objective will be accomplished by testing the oxidation capacity of lipoprotein fractions before and after meal supplementation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tomato Meal

A tomato meal will be fed with and without avocado.

Group Type OTHER

Post-prandial Feeding Study

Intervention Type OTHER

Carrot Meal

A carrot meal will be fed with and without avocado.

Group Type OTHER

Post-prandial Feeding Study

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post-prandial Feeding Study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hass Avocado Board

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jessica Cooperstone

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven J Schwartz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University Clinical Research Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28515067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24899156 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

60030575

Identifier Type: OTHER

Identifier Source: secondary_id

2011H0159

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lycopene in Healthy Male Participants
NCT00450957 COMPLETED PHASE1
Vitamin A Value of Spirulina Carotenoids in Humans
NCT00680277 COMPLETED PHASE1/PHASE2
Broccoli Supplement Dose Response
NCT03399656 COMPLETED NA
Lutein Absorption in Healthy Adults
NCT01730898 COMPLETED PHASE3