Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken

March 27, 2026 updated by: Cornell University

Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability

The purpose of the research is to evaluate if chicken or eggs obtained from chickens that are fed a diet that contains omega-3 fatty acids (DHA/EPA), or vitamin D (as 25(OH)D) provides additional health benefits by improving the status of omega-3 fatty acids or 25(OH)D in healthy adults who eat this bioenhanced chicken or eggs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken and of eggs produced from bioenhanced chickens. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle) or in enhanced eggs produced from supplemented chickens.

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.
Observational

Enrollment (Estimated)

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.
84

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kimberly O'Brien, PhD
  • Phone Number: (607) 255-3743
  • Email: koo4@cornell.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • Ithaca, New York, United States, 14850
        • Human Metabolic Research Unit

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

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy adults from Ithaca, NY

Description

Inclusion Criteria:

  • healthy adults
  • Non-smoking
  • Age between 18- 35 yo
  • Females: premenopausal and not pregnant or lactating
  • Body mass index (BMI) between 18 - 30 kg/m2.
  • No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

Exclusion Criteria:

  • BMI <18 or > 30 kg/m2,
  • Age <18 y or > 50y,
  • Smoking
  • Pregnancy, lactating
  • Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
  • Take vitamin and mineral supplementations

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
DHA bioenhanced poultry/eggs or non-fortified poultry/eggs

In this study a group of individuals will be recruited and randomized to participate in a crossover comparing DHA enhanced poultry or control (non-fortified) poultry or to compare DHA enhanced eggs to control (non-fortified) eggs.

Group 1: Participants will be asked to consume two meals of chicken, one meal will contain chicken that has been fed omega-3 fatty acids so the chicken contains omega 3 (DHA/EPA) fatty acids, together with a placebo, and the other meal will consist of non enhanced chicken and a DHA supplement.

Group 2: Participants will be asked to consume two meals of eggs, one meal will contain DHA bioenhanced eggs, together with a placebo, and the other meal will consist of non enhanced eggs and a DHA supplement.

Each participant will be asked to eat both of these forms of chicken in random order. Each study is expected to take 9-hours and the two visits will be separated by a period of two weeks. A total of 5 blood samples will be collected over a 9-h period.
Dietary supplement: DHA/EPA fortified chicken plus Placebo
For participants who received DHA/EPA fortified chicken
Dietary supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3
Used in the crossover part of the study given to the group who did not received DHA bio-enhanced chicken
Dietary supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo
For the participants who received DHA/EPA fortified eggs
Dietary supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3
for the participants who received non-DHA bio-enhanced eggs plus supplement DHA Omega-3
25(OH)D bioenhanced poultry and eggs

25D3 Group: Weeks 0-4: Consume 5 weekly servings of 25(OH)D-enhanced chicken (300 g/serving; 1,500 g/week) + daily placebo Weeks 5-8: + additional 5 weekly 25(OH)D-enhanced eggs

Placebo Group:

Weeks 0-4: Consume 5 weekly servings of control chicken + daily placebo Weeks 5-8: + additional 5 weekly control eggs

D3 Group:

Weeks 0-4: Consume 5 weekly servings of control chicken + daily vitamin D3 (1000 IU).

Weeks 5-8: + additional 5 weekly control eggs

Participation in the study is expected to last 8 weeks. Individuals will be asked to come to the Human Metabolic Research Unit (HMRU) on the Cornell campus each week to pick up weekly food supplies. At five timepoints during the 8-week study, a blood draw will be collected to measure vitamin D status and other markers (e.g., hemoglobin, hematocrit, blood lipids). Each blood draw visit will take approximately 30 minutes. The total estimated time for all study visits at the HMRU is 6-7 hours over the 8-week period.
Dietary supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement
Provided to participants in the group where they consumed non-fortified chicken/eggs
Dietary supplement: 25(OH)D bioenhanced chicken and eggs plus placebo
participants will receive 25(OH)D bioenhanced chicken and eggs plus a placebo as a dietary intervention
Other: non-25(OH)D fortified chicken/eggs plus placebo
Provided to participants in the group where they consumed non-fortified chicken/eggs + placebo pills

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
Concentration of plasma DHA concentrations
Time Frame: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal
Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption
Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal
Concentrations of serum 25(OH)D, vitamin D2, vitamin D3, 1,25(OH)2D and 24,25(OH)2D3 and vitamin D binding protein
Time Frame: Baseline, and time course of week 2, week 4, week 6, week 8
Measuring serum 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption
Baseline, and time course of week 2, week 4, week 6, week 8

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.
Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

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.
December 4, 2021

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.
December 11, 2024

Study Completion (Estimated)

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 30, 2026

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).
February 7, 2022

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.
February 16, 2022

First Posted (Actual)

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.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

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.
April 1, 2026

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.
March 27, 2026

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.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 1904008786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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