Healthy Adult ParticipantsSCRAMBLENCT07859280
Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
A study testing Vitamin D3 bioenhanced eggs and 25(OH)D3 bioenhanced eggs in people with Healthy Adult Participants and Vitamin D Insufficiency, run by Cornell University at 1 site in United States.
Trial summary
The purpose of this research is to evaluate if 1) consumption of vitamin D3- or 25(OH)D3-biofortified eggs will increase vitamin D and 25(OH)D status in young adults who consume these bioenhanced eggs, 2) to determine if the gut microbiome profile is associated with 25(OH)D or vitamin D status and 3) to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Vitamin D Insufficiency
- What is being tested?
- Vitamin D3 bioenhanced eggs and 25(OH)D3 bioenhanced eggs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- Non-smoking
- Age between 18- 40 years
- Females: premenopausal and not pregnant or lactating
- Body mass index (BMI) between 18.5-27.0 kg/m2.
- No planned trip(s) to lower latitudes during the 8-week study
Who cannot join
- BMI <18.5 or > 27.0 kg/m2,
- Age <18 y or > 40y,
- Smoking
- Pregnancy, lactating
- Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/use of medications known to impact vitamin D and 25(OH)D absorption
- Been prescribed antibiotics within 3 months before enrolling
- History or current diagnosis of any of the following conditions: intestinal problems (cystic fibrosis, Crohn's Disease, IBD, etc.), blood disorders (sickle cell, thalassemia, etc.), stomach problems (ulcers or other problems requiring antacids), joint diseases requiring anti-inflammatory medication, or asthma.
- Planned trip(s) to lower latitudes during the 8-week study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Human Metabolic Research Unit
Ithaca, New York, 14850
Jennifer Thompson, NP, 215-565-6742, jjt226@cornell.edu
About this study
Official title: Biofortified Vitamin D Metabolites in Eggs and Their Impact on Vitamin D Status and the Gut Microbiome
The purpose of this research is to evaluate if 1) consumption of vitamin D3- or 25(OH)D3-biofortified eggs will increase vitamin D and 25(OH)D status in young adults who consume these bioenhanced eggs, 2) to determine if the gut microbiome profile is associated with 25(OH)D or vitamin D status and 3) to evaluate possible changes in the gut microbiome following an 8-week supplementation period providing 5(OH)D- or vitamin D bioenhanced eggs.
Read the detailed description
In the wintertime, decreased UVB exposure limits vitamin D synthesis. Vitamin D insufficiency is common in the US and globally, with insufficiency evident in 41% of US adults over the age of 18 years, and has been linked to several adverse health outcomes. While dairy products are the major source of dietary vitamin D intake for the US public, little attention has been placed on other animal products (meat or eggs) as a source of vitamin D3 and 25(OH)D3. Determining the bioavailability of vitamin D-fortified eggs can inform updated dietary guidelines.
Decreased 25(OH)D status has also been associated with a less diverse gut microbiome. Additionally, little attention has been given to how bioenhanced foods containing vitamin D3 or 25(OH)D3 may differentially shape the gut microbiome and thus human vitamin D metabolism. Prior research shows a strong correlation between 1,25(OH)2D3 concentration and gut microbial diversity in elderly men. Further research will help inform recommendations that address the efficacy of the form of vitamin D ingested from food products and how vitamin D status may shape the gut microbiota.
- Being tested
- Vitamin D3 bioenhanced eggs, 25(OH)D3 bioenhanced eggs
- Keywords
- Vitamin D, Biofortified eggs, Gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 bioenhanced eggsDietary supplement
Six vitamin D3-fortified eggs per week will be provided to participants to consume each week for 8 weeks
25(OH)D3 bioenhanced eggsDietary supplement
Six 25(OH)D3-fortified eggs will per week be provided to participants to consume each week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 bioenhanced eggs | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 bioenhanced eggs |
| 25(OH)D3 bioenhanced eggs | Experimental | Not described Receives: Dietary Supplement: 25(OH)D3 bioenhanced eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Status
Serum concentrations of vitamin D2, vitamin D3, 25(OH)D2, 25(OH)D3, 1,25(OH)2D2, 1,25(OH)2D3, 24,25(OH)2D3, and vitamin D binding protein concentration will be measured biweekly over 8 weeks to assess vitamin D and 25(OH)D bioavailability.
Measured: Baseline, and time course of week 2, week 4, week 6, week 8
Gut microbiome composition
Fecal samples will be collected for metagenomic analyses to evaluate the impact of vitamin D or 25(OH)D status and intake on the gut microbiome.
Measured: Baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
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 Healthy Adult ParticipantsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859280
- Sponsor's protocol ID
- IRB0150561
- Other IDs
- 2026-67017-46090
- Acronym
- SCRAMBLE
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofortified Vitamin D Metabolites in Eggs and Their Impact on Vitamin D Status and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT07859280
- Acronym / sponsor ID
- SCRAMBLE / IRB0150561
- Keywords
- Vitamin D, Biofortified eggs, Gut microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 Oct 2026 (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 this research is to evaluate if 1) consumption of vitamin D3- or 25(OH)D3-biofortified eggs will increase vitamin D and 25(OH)D status in young adults who consume these bioenhanced eggs, 2) to determine if the gut microbiome profile is associated with 25(OH)D or vitamin D status and 3) to evaluate possible changes in the gut microbiome following an 8-week supplementation period providing 5(OH)D- or vitamin D bioenhanced eggs.
Detailed description
In the wintertime, decreased UVB exposure limits vitamin D synthesis. Vitamin D insufficiency is common in the US and globally, with insufficiency evident in 41% of US adults over the age of 18 years, and has been linked to several adverse health outcomes. While dairy products are the major source of dietary vitamin D intake for the US public, little attention has been placed on other animal products (meat or eggs) as a source of vitamin D3 and 25(OH)D3. Determining the bioavailability of vitamin D-fortified eggs can inform updated dietary guidelines.
Decreased 25(OH)D status has also been associated with a less diverse gut microbiome. Additionally, little attention has been given to how bioenhanced foods containing vitamin D3 or 25(OH)D3 may differentially shape the gut microbiome and thus human vitamin D metabolism. Prior research shows a strong correlation between 1,25(OH)2D3 concentration and gut microbial diversity in elderly men. Further research will help inform recommendations that address the efficacy of the form of vitamin D ingested from food products and how vitamin D status may shape the gut microbiota.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 bioenhanced eggs | Experimental | Dietary Supplement: Vitamin D3 bioenhanced eggs |
| 25(OH)D3 bioenhanced eggs | Experimental | Dietary Supplement: 25(OH)D3 bioenhanced eggs |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults
- Non-smoking
- Age between 18- 40 years
- Females: premenopausal and not pregnant or lactating
- Body mass index (BMI) between 18.5-27.0 kg/m2.
Key exclusion criteria (8 listed)
- BMI <18.5 or > 27.0 kg/m2,
- Age <18 y or > 40y,
- Smoking
- Pregnancy, lactating
- Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/use of medications known to impact vitamin D and 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 |
|---|---|---|
| Vitamin D3 bioenhanced eggsSix vitamin D3-fortified eggs per week will be provided to participants to consume each week for 8 weeks | Dietary supplement | Vitamin D3 bioenhanced eggs |
| 25(OH)D3 bioenhanced eggsSix 25(OH)D3-fortified eggs will per week be provided to participants to consume each week for 8 weeks. | Dietary supplement | 25(OH)D3 bioenhanced eggs |
Primary outcome
Vitamin D Status
Time frame: Baseline, and time course of week 2, week 4, week 6, week 8
Serum concentrations of vitamin D2, vitamin D3, 25(OH)D2, 25(OH)D3, 1,25(OH)2D2, 1,25(OH)2D3, 24,25(OH)2D3, and vitamin D binding protein concentration will be measured biweekly over 8 weeks to assess vitamin D and 25(OH)D bioavailability.
Gut microbiome composition
Time frame: Baseline, week 4, week 8
Fecal samples will be collected for metagenomic analyses to evaluate the impact of vitamin D or 25(OH)D status and intake on the gut microbiome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 bioenhanced eggs and 25(OH)D3 bioenhanced eggs in people with Healthy Adult Participants and Vitamin D Insufficiency, 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 8 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: looking for participants now, as of the sponsor's last update on 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly O'Brien, PhD ((607) 255-3743, koo4@cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D Status (time frame: Baseline, and time course of week 2, week 4, week 6, week 8). 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 NCT07859280, 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 5 Oct 2026.