Nutrition, HealthyNCT05248737
Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken
An observational study of Nutrition, Healthy, run by Cornell University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement and non-DHA bio-enhanced chicken plus supplement DHA Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2021to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults from Ithaca, NY
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolic Research Unit
Ithaca, New York, 14850
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- DHA/EPA fortified chicken plus Placebo, non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement, non-DHA bio-enhanced chicken plus supplement DHA Omega-3, 25(OH)D bioenhanced chicken and eggs plus placebo, Dietary Supplement: DHA/EPA fortified eggs plus Placebo
- Keywords
- Vitamin D, Omega-3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA/EPA fortified chicken plus PlaceboDietary supplement
For participants who received DHA/EPA fortified chicken
non-25(OH)D fortified chicken/eggs plus vitamin D3 supplementDietary supplement
Provided to participants in the group where they consumed non-fortified chicken/eggs
non-DHA bio-enhanced chicken plus supplement DHA Omega-3Dietary supplement
Used in the crossover part of the study given to the group who did not received DHA bio-enhanced chicken
25(OH)D bioenhanced chicken and eggs plus placeboDietary supplement
participants will receive 25(OH)D bioenhanced chicken and eggs plus a placebo as a dietary intervention
Dietary Supplement: DHA/EPA fortified eggs plus PlaceboDietary supplement
For the participants who received DHA/EPA fortified eggs
non-DHA bio-enhanced eggs plus supplement DHA Omega-3Dietary supplement
for the participants who received non-DHA bio-enhanced eggs plus supplement DHA Omega-3
non-25(OH)D fortified chicken/eggs plus placeboOther
Provided to participants in the group where they consumed non-fortified chicken/eggs + placebo pills
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: DHA/EPA fortified chicken plus Placebo; Dietary Supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3; Dietary Supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo; Dietary Supplement: 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. Receives: Dietary Supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement; Dietary Supplement: 25(OH)D bioenhanced chicken and eggs plus placebo; Other: non-25(OH)D fortified chicken/eggs plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of plasma DHA concentrations
Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption
Measured: 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
Measuring serum 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption
Measured: Baseline, and time course of week 2, week 4, week 6, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start4 Dec 2021
- Primary completion11 Dec 2024
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248737
- Sponsor's protocol ID
- 1904008786
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie Y, Kalia S, Ou KJ, Sun T, Bender E, Lin K, Bottje W, Lei X, O'Brien KO. 25-Hydroxyvitamin D3 Bioenriched Chicken and Eggs Maintained Vitamin D Status Over the Winter in Healthy Adult Males and Females: A Randomized Controlled Trial. Am J Clin Nutr. 2026 Sep 9:101519. doi: 10.1016/j.ajcnut.2026.101519. Online ahead of print.
PubMed 42716471
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability
- ClinicalTrials.gov ID
- NCT05248737
- Acronym / sponsor ID
- 1904008786
- Conditions
- Nutrition, Healthy
- Keywords
- Vitamin D, Omega-3 fatty acids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 4 Dec 2021 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA bioenhanced poultry/eggs or non-fortified poultry/eggs | – | Dietary Supplement: DHA/EPA fortified chicken plus Placebo, Dietary Supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3, Dietary Supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo, Dietary Supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3In 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. |
| 25(OH)D bioenhanced poultry and eggs | – | Dietary Supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement, Dietary Supplement: 25(OH)D bioenhanced chicken and eggs plus placebo, Other: non-25(OH)D fortified chicken/eggs plus placebo25D3 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults from Ithaca, NY
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA/EPA fortified chicken plus PlaceboFor participants who received DHA/EPA fortified chicken | Dietary supplement | DHA bioenhanced poultry/eggs or non-fortified poultry/eggs |
| non-25(OH)D fortified chicken/eggs plus vitamin D3 supplementProvided to participants in the group where they consumed non-fortified chicken/eggs | Dietary supplement | 25(OH)D bioenhanced poultry and eggs |
| non-DHA bio-enhanced chicken plus supplement DHA Omega-3Used in the crossover part of the study given to the group who did not received DHA bio-enhanced chicken | Dietary supplement | DHA bioenhanced poultry/eggs or non-fortified poultry/eggs |
| 25(OH)D bioenhanced chicken and eggs plus placeboparticipants will receive 25(OH)D bioenhanced chicken and eggs plus a placebo as a dietary intervention | Dietary supplement | 25(OH)D bioenhanced poultry and eggs |
| Dietary Supplement: DHA/EPA fortified eggs plus PlaceboFor the participants who received DHA/EPA fortified eggs | Dietary supplement | DHA bioenhanced poultry/eggs or non-fortified poultry/eggs |
| non-DHA bio-enhanced eggs plus supplement DHA Omega-3for the participants who received non-DHA bio-enhanced eggs plus supplement DHA Omega-3 | Dietary supplement | DHA bioenhanced poultry/eggs or non-fortified poultry/eggs |
| non-25(OH)D fortified chicken/eggs plus placeboProvided to participants in the group where they consumed non-fortified chicken/eggs + placebo pills | Other | 25(OH)D bioenhanced poultry and eggs |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Derived from this study: PubMed 42716471Xie Y, Kalia S, Ou KJ, Sun T, Bender E, Lin K, Bottje W, Lei X, O'Brien KO. 25-Hydroxyvitamin D3 Bioenriched Chicken and Eggs Maintained Vitamin D Status Over the Winter in Healthy Adult Males and Females: A Randomized Controlled Trial. Am J Clin Nutr. 2026 Sep 9:101519. doi: 10.1016/j.ajcnut.2026.101519. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, Healthy, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of plasma DHA concentrations (time frame: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.