Nutritional RequirementsNCT04286321
Achieving Nutritional Adequacy Of Vitamin K With An Egg/Plant-Based Food Pairing
A study testing Zero hard-boiled egg at 0 h, One hard-boiled egg at 0 h and Two hard-boiled eggs at 0 h in people with Nutritional Requirements, run by Ohio State University at 1 site in United States.
Trial summary
Malnutrition of the fat-soluble nutrient vitamin K (phylloquinone; PQ) is problematic. Since PQ is rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate PQ bioavailability by pairing vegetables with lipid-rich foods have been emphasized. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Requirements
- What is being tested?
- Zero hard-boiled egg at 0 h, One hard-boiled egg at 0 h and Two hard-boiled eggs at 0 h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 15 Jul 2024
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) = 19-25 kg/m2
- Normolipidemic (total cholesterol <240 mg/dL; triglyceride <150 mg/dL)
- Fasting glucose <100 mg/dL
- Normal hematocrit level (41%-50% for men and 36%-48% for women)
- Normal hemoglobin level (13.5-17.5 g/dL for men and 12.0-15.5 g/dL for women)
- No use of dietary supplements for >1 month
Show all 9Show fewer
- No use of medications that affect lipid or glucose metabolism
- Non-smoker
- No history of gastrointestinal disorders
Who cannot join
- Egg allergy
- Alcohol intake > 2 drinks per day
- Aerobic activity >7 h/wk
- Body mass change >2 kg in the past 1 month
- Women who are pregnant, lactating, or initiated or changed birth control in the past 3 month
- Vegetarian
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition of the fat-soluble nutrient vitamin K (phylloquinone; PQ) is problematic. Since PQ is rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate PQ bioavailability by pairing vegetables with lipid-rich foods have been emphasized. The purpose of this study is to use deuterium-labeled spinach (containing stable isotopes of PQ) to validate eggs as a dietary tool to improve PQ bioavailability directly from a model plant food, and hence achieve nutrient adequacy. It is expected that compared with deuterium-labeled spinach alone, co-ingestion of eggs will increase plasma bioavailability of spinach-derived deuterium-labeled PQ without affecting time to maximal concentrations or half-lives. Further, phospholipid-rich egg yolk lipid will enhance nutrient bioavailability compared with vegetable oil. The outcomes will serve as the foundation for easy-to-implement message of public health importance in support of whole eggs and egg whites as part of a plant-based dietary pattern.
Read the detailed description
In the US, 43-63% of men and women do not meet recommended intakes for PQ. Dietary recommendations strongly encourage a diet rich in fruits and vegetables to meet dietary PQ requirements. However, PQ bioavailability from most plant foods is quite poor, thereby emphasizing a need for effective food pairings that can enhance the absorption and promote adequate status of these health-promoting nutrients. The objective of this study is to demonstrate that an effective food pairing of spinach with phospholipid lipid-rich eggs promotes intestinal absorption of spinach-derived PQ, and hence achieve nutrient adequacy. Our hypothesis is that the bioavailability of PQ from deuterium-labeled spinach will be potentiated by egg intake in a dose-dependent manner by increasing their secretion in intestinal-derived chylomicrons. Furthermore, phospholipid-rich whole eggs will enhance spinach-derived PQ bioavailability compared with vegetable oil, and will be most functionally responsible for the benefits of eggs to enhance nutrient absorption. Additionally, egg whites will more greatly promote nutrient bioaccessibility compared with spinach alone.
To test this, our specific aim is to assess egg-mediated improvements in PQ bioavailability by conducting a cross-over pharmacokinetic study in healthy men and women. In Study Arms 1-4, participants will ingest deuterium-labeled spinach (containing 500 μg PQ) with 0, 1, 2, or 3 hardboiled eggs (containing 0, 4.8, 9.6, or 14.4 g total fat, respectively). In Study Arm 5, participants will ingest spinach alone followed by 1 egg 3-hours later. In Study Arm 6, participants will ingest spinach with 1 egg followed by another egg 3-hours later. In Study Arm 7, participants will ingest spinach with two egg whites. In Study Arm 8, participants will ingest spinach with 9.6 grams of vegetable oil. Thus, Study Arms 1-4 will test the dose-dependent effects of eggs on PQ bioavailability, Study Arms 5-6 (with comparison to Study Arms 1 and 2) will test the 'timing'-dependent effects of eggs on PQ bioavailability, and Study Arms 7-8 will test the matrix effect on PQ bioavailability. Eucaloric diets will be controlled for PQ intakes for 3 d prior to and during the initial 24 h of each trial to minimize heterogeneity of pharmacokinetic responses. Spinach-derived deuterium-labeled PQ will be measured in plasma and isolated chylomicrons collected at timed intervals from 0-72 h post-meal ingestion, and biomarkers of antioxidant status and oxidative distress will be assessed at baseline (0 h) of each trial. Outcomes from this study are expected to establish that egg lipids substantially enhance plant-derived PQ bioavailability (based on AUC0-72 h, Cmax, and % estimated absorption) independent of any changes in oxidative distress.
The rationale for this study is that, by establishing the efficacy of eggs and egg yolk lipids to potentiate plant-derived fat-soluble nutrient bioavailability, a strong framework will exist for an easily implementable health-promoting food pairing strategy to overcome malnutrition of PQ.
- Conditions
- Nutritional Requirements
- Being tested
- Zero hard-boiled egg at 0 h, One hard-boiled egg at 0 h, Two hard-boiled eggs at 0 h, Three hard-boiled eggs at 0 h, One hard-boiled egg at 3 h
- Keywords
- Vitamin K, Egg, Spinach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zero hard-boiled egg at 0 hOther
No eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 0 hOther
One egg will be consumed on test day along with spinach consumption
Two hard-boiled eggs at 0 hOther
Two eggs will be consumed on test day along with spinach consumption
Three hard-boiled eggs at 0 hOther
Three eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 3 hOther
One egg will be consumed on test day three hours after spinach consumption
One hard-boiled egg at 0 h + One hard-boiled egg at 3 hOther
Two eggs will be consumed on test day: one along with spinach consumption and the other one three hours after spinach consumption
Two egg whites at 0 hOther
Two egg whites will be consumed on test day along with spinach consumption
Vegetable oil at 0 hOther
9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
| Study group | Role | What they receive |
|---|---|---|
| Zero hard-boiled egg | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested alone prior to the 72-h pharmacokinetics trial. Receives: Other: Zero hard-boiled egg at 0 h |
| One hard-boiled egg at 0 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested along with one hard-boiled egg prior to the 72-h pharmacokinetics trial. Receives: Other: One hard-boiled egg at 0 h |
| Two hard-boiled eggs at 0 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested with two whole eggs (9.6 g fat) prior to the 72-h pharmacokinetics trial. Receives: Other: Two hard-boiled eggs at 0 h |
| Three hard-boiled eggs at 0 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested along with three hard-boiled eggs prior to the 72-h pharmacokinetics trial. Receives: Other: Three hard-boiled eggs at 0 h |
| One hard-boiled egg at 3 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested alone at 0 h prior to the 72-h pharmacokinetics trial followed by one hard-boiled egg 3 hours after spinach consumption. Receives: Other: One hard-boiled egg at 3 h |
| One hard-boiled egg at 0 h + One hard-boiled egg at 3 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested along with one hard-boiled egg at 0 h prior to the 72-h pharmacokinetics trial followed by one egg 3 hours after spinach consumption. Receives: Other: One hard-boiled egg at 0 h + One hard-boiled egg at 3 h |
| Two egg whites at 0 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial. Receives: Other: Two egg whites at 0 h |
| Vegetable oil at 0 h | Experimental | Deuterium-labeled spinach containing 500 μg PQ will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial. Receives: Other: Vegetable oil at 0 h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin K Bioavailability
Area under the curve of deuterium-labeled phylloquinone
Measured: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Secondary outcomes (5)
Vitamin K Tmax
Time to reach maximum plasma concentration of deuterium-labeled phylloquinone
Measured: 0-72 hours post-ingestion of spinach
Chylomicron Vitamin K
Deuterium-labeled phylloquinone concentration in chylomicron
Measured: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
Estimated Absorption (%Dose) of Vitamin K
Absorption of deuterium-labeled phylloquinone
Measured: 0-72 hours post-ingestion of spinach
Vitamin K Cmax
Maximum plasma concentration of deuterium-labeled phylloquinone
Measured: 0-72 hours post-ingestion of spinach
Elimination Rate of Vitamin K
Rate of plasma elimination of deuterium-labeled phylloquinone
Measured: 0-72 hours post-ingestion of spinach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jun 2021
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional RequirementsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Bruno, Ohio State University
- Investigators
- Richard Bruno, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286321
- Sponsor's protocol ID
- 2019H0504-B
- Status last verified
- May 2025
- First submitted
- 22 Feb 2020
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Nutritional Adequacy Of Vitamin K With An Egg/Plant-Based Food Pairing
- ClinicalTrials.gov ID
- NCT04286321
- Acronym / sponsor ID
- 2019H0504-B
- Conditions
- Nutritional Requirements
- Keywords
- Vitamin K, Egg, Spinach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 27 Feb 2020 (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.
Malnutrition of the fat-soluble nutrient vitamin K (phylloquinone; PQ) is problematic. Since PQ is rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate PQ bioavailability by pairing vegetables with lipid-rich foods have been emphasized. The purpose of this study is to use deuterium-labeled spinach (containing stable isotopes of PQ) to validate eggs as a dietary tool to improve PQ bioavailability directly from a model plant food, and hence achieve nutrient adequacy. It is expected that compared with deuterium-labeled spinach alone, co-ingestion of eggs will increase plasma bioavailability of spinach-derived deuterium-labeled PQ without affecting time to maximal concentrations or half-lives. Further, phospholipid-rich egg yolk lipid will enhance nutrient bioavailability compared with vegetable oil. The outcomes will serve as the foundation for easy-to-implement message of public health importance in support of whole eggs and egg whites as part of a plant-based dietary pattern.
Detailed description
In the US, 43-63% of men and women do not meet recommended intakes for PQ. Dietary recommendations strongly encourage a diet rich in fruits and vegetables to meet dietary PQ requirements. However, PQ bioavailability from most plant foods is quite poor, thereby emphasizing a need for effective food pairings that can enhance the absorption and promote adequate status of these health-promoting nutrients. The objective of this study is to demonstrate that an effective food pairing of spinach with phospholipid lipid-rich eggs promotes intestinal absorption of spinach-derived PQ, and hence achieve nutrient adequacy. Our hypothesis is that the bioavailability of PQ from deuterium-labeled spinach will be potentiated by egg intake in a dose-dependent manner by increasing their secretion in intestinal-derived chylomicrons. Furthermore, phospholipid-rich whole eggs will enhance spinach-derived PQ bioavailability compared with vegetable oil, and will be most functionally responsible for the benefits of eggs to enhance nutrient absorption. Additionally, egg whites will more greatly promote nutrient bioaccessibility compared with spinach alone.
To test this, our specific aim is to assess egg-mediated improvements in PQ bioavailability by conducting a cross-over pharmacokinetic study in healthy men and women. In Study Arms 1-4, participants will ingest deuterium-labeled spinach (containing 500 μg PQ) with 0, 1, 2, or 3 hardboiled eggs (containing 0, 4.8, 9.6, or 14.4 g total fat, respectively). In Study Arm 5, participants will ingest spinach alone followed by 1 egg 3-hours later. In Study Arm 6, participants will ingest spinach with 1 egg followed by another egg 3-hours later. In Study Arm 7, participants will ingest spinach with two egg whites. In Study Arm 8, participants will ingest spinach with 9.6 grams of vegetable oil. Thus, Study Arms 1-4 will test the dose-dependent effects of eggs on PQ bioavailability, Study Arms 5-6 (with comparison to Study Arms 1 and 2) will test the 'timing'-dependent effects of eggs on PQ bioavailability, and Study Arms 7-8 will test the matrix effect on PQ bioavailability. Eucaloric diets will be controlled for PQ intakes for 3 d prior to and during the initial 24 h of each trial to minimize heterogeneity of pharmacokinetic responses. Spinach-derived deuterium-labeled PQ will be measured in plasma and isolated chylomicrons collected at timed intervals from 0-72 h post-meal ingestion, and biomarkers of antioxidant status and oxidative distress will be assessed at baseline (0 h) of each trial. Outcomes from this study are expected to establish that egg lipids substantially enhance plant-derived PQ bioavailability (based on AUC0-72 h, Cmax, and % estimated absorption) independent of any changes in oxidative distress.
The rationale for this study is that, by establishing the efficacy of eggs and egg yolk lipids to potentiate plant-derived fat-soluble nutrient bioavailability, a strong framework will exist for an easily implementable health-promoting food pairing strategy to overcome malnutrition of PQ.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Zero hard-boiled egg | Experimental | Other: Zero hard-boiled egg at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested alone prior to the 72-h pharmacokinetics trial. |
| One hard-boiled egg at 0 h | Experimental | Other: One hard-boiled egg at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested along with one hard-boiled egg prior to the 72-h pharmacokinetics trial. |
| Two hard-boiled eggs at 0 h | Experimental | Other: Two hard-boiled eggs at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested with two whole eggs (9.6 g fat) prior to the 72-h pharmacokinetics trial. |
| Three hard-boiled eggs at 0 h | Experimental | Other: Three hard-boiled eggs at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested along with three hard-boiled eggs prior to the 72-h pharmacokinetics trial. |
| One hard-boiled egg at 3 h | Experimental | Other: One hard-boiled egg at 3 hDeuterium-labeled spinach containing 500 μg PQ will be ingested alone at 0 h prior to the 72-h pharmacokinetics trial followed by one hard-boiled egg 3 hours after spinach consumption. |
| One hard-boiled egg at 0 h + One hard-boiled egg at 3 h | Experimental | Other: One hard-boiled egg at 0 h + One hard-boiled egg at 3 hDeuterium-labeled spinach containing 500 μg PQ will be ingested along with one hard-boiled egg at 0 h prior to the 72-h pharmacokinetics trial followed by one egg 3 hours after spinach consumption. |
| Two egg whites at 0 h | Experimental | Other: Two egg whites at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial. |
| Vegetable oil at 0 h | Experimental | Other: Vegetable oil at 0 hDeuterium-labeled spinach containing 500 μg PQ will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Body Mass Index (BMI) = 19-25 kg/m2
- Normolipidemic (total cholesterol <240 mg/dL; triglyceride <150 mg/dL)
- Fasting glucose <100 mg/dL
- Normal hematocrit level (41%-50% for men and 36%-48% for women)
- Normal hemoglobin level (13.5-17.5 g/dL for men and 12.0-15.5 g/dL for women)
Key exclusion criteria (6 listed)
- Egg allergy
- Alcohol intake > 2 drinks per day
- Aerobic activity >7 h/wk
- Body mass change >2 kg in the past 1 month
- Women who are pregnant, lactating, or initiated or changed birth control in the past 3 month
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 |
|---|---|---|
| Zero hard-boiled egg at 0 hNo eggs will be consumed on test day along with spinach consumption | Other | Zero hard-boiled egg |
| One hard-boiled egg at 0 hOne egg will be consumed on test day along with spinach consumption | Other | One hard-boiled egg at 0 h |
| Two hard-boiled eggs at 0 hTwo eggs will be consumed on test day along with spinach consumption | Other | Two hard-boiled eggs at 0 h |
| Three hard-boiled eggs at 0 hThree eggs will be consumed on test day along with spinach consumption | Other | Three hard-boiled eggs at 0 h |
| One hard-boiled egg at 3 hOne egg will be consumed on test day three hours after spinach consumption | Other | One hard-boiled egg at 3 h |
| One hard-boiled egg at 0 h + One hard-boiled egg at 3 hTwo eggs will be consumed on test day: one along with spinach consumption and the other one three hours after spinach consumption | Other | One hard-boiled egg at 0 h + One hard-boiled egg at 3 h |
| Two egg whites at 0 hTwo egg whites will be consumed on test day along with spinach consumption | Other | Two egg whites at 0 h |
| Vegetable oil at 0 h9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption | Other | Vegetable oil at 0 h |
Primary outcome
Vitamin K Bioavailability
Time frame: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Area under the curve of deuterium-labeled phylloquinone
5 secondary outcomes
Vitamin K Tmax
Time frame: 0-72 hours post-ingestion of spinach
Chylomicron Vitamin K
Time frame: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
Estimated Absorption (%Dose) of Vitamin K
Time frame: 0-72 hours post-ingestion of spinach
Vitamin K Cmax
Time frame: 0-72 hours post-ingestion of spinach
Elimination Rate of Vitamin K
Time frame: 0-72 hours post-ingestion of spinach
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 3 Jun 2025.
Related trials for Nutritional Requirements
RecruitingObservational study
Optimizing Nutrition and Milk (Opti-NuM) Project
Very Low Birth Weight Baby, Early Nutrition and the Preterm Infant
RecruitingObservational study
Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children
Nutritional Requirements
Not yet recruitingObservational study
Displacement of Iodine Balance Value During Pregnancy and the Mechanism of Breast Iodine Homeostasis During Lactation
Nutritional Requirements
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.
Richard Bruno, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zero hard-boiled egg at 0 h, One hard-boiled egg at 0 h and Two hard-boiled eggs at 0 h in people with Nutritional Requirements, run by Ohio State 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 9 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 3 Jun 2025. 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?
Vitamin K Bioavailability (time frame: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.