Effects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food

June 17, 2014 updated by: Wayne Campbell, Purdue University

EffectEffects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health beneficial properties and are known to fight against disease. Eggs are known to be a good source of carotenoids and eggs may improve the absorption of carotenoids found in co-consumed fruits and vegetables. Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will increase carotenoid absorption.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily. However, average fruit and vegetable intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables may further result in the limited availability of fat soluble, health-promoting, phytochemicals such as carotenoids from these foods. Dietary carotenoids have beneficial biological properties including antioxidant and anti-inflammatory effects and scientific research supports the protective effects of carotenoids against many degenerative diseases, including cardiovascular diseases, age-related macular degeneration, and some types of cancer. Therefore, either low intake or inefficient bioavailability of carotenoids from fruits and vegetables may reduce their potential effectiveness as disease preventative compounds. The bioavailability of carotenoids from a meal can be affected by several factors, including food matrix, type of food processing or cooking, interactions with other dietary compounds during digestion and absorption, gut status which may affect digestion and absorption processes, and nutritional status. Co-consumption of carotenoid rich foods with dietary lipids may be one of the most effective stimulators of carotenoid absorption among factors that influence their bioaccessibility and bioavailability. Eggs are known to be a highly bioavailable source of carotenoids, presumably due to the presence of lipid and phospholipid in egg yolk. The highly bioavailable nature of carotenoids from eggs suggest that egg derived factors may be leveraged to improve bioavailability of other carotenoids found in co-consumed fruits and vegetables. While promising, very limited data exist on the impact of a co-consumed food source of lipid, such as eggs, to enhance carotenoid absorption. This study is designed to assess the beneficial effects of egg consumption on carotenoids absorption from a complex meal, beyond those found in egg.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47907
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Male 19 to 45y BMI 18.5-29.9kg/m2 generally healthy non-smoker

Exclusion Criteria:

Female deep vein thrombosis intestinal disorders fasting blood glucose >110mg/dL smoking drinking more than 3 alcoholic drinks per day taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Egg consumption
No egg 75g of scrambled eggs 150g of scrambled eggs
Other: Egg consumption
Subjects will participate in 3 testing days (randomized, crossover design). Each day, the subject will consume a carefully portioned mix-vegetable salad without eggs (C, control); 75g (about 1½ eggs) scrambled whole egg (LE, low egg), and 150g (about 3 eggs) scrambled whole egg (HE, high egg). Prior to each testing day, subjects will consume a low-carotenoid diet for 7 days to reduce blood carotenoid concentration. In the testing day, blood collected every 60 minutes for 10 hours will be processed to analyze carotenoid and vitamin E concentrations. At the 5-h time point, subjects will be fed a low fat (< 2g) and low carotenoid (< 2000µg) meal as the 2nd meal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Carotenoids absorption
Time Frame: 6-8 weeks
Carotenoids absorption Area under the curve of carotenoids such as lutein, zeaxanthin, α-carotene, α-cryptoxanthin, β-cryptoxanthin, β-carotene, and lycopene and vitamin E in plasma triacylglycerol rich lipoproteins fractions
6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Egg Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wayne W Campbell, Ph.D, Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1308013929

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