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NCT04286321 · ClinicalTrials.gov registry record · NA

Achieving Nutritional Adequacy Of Vitamin K With An Egg/Plant-Based Food Pairing

A NA study, sponsored by Ohio State University.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT04286321: Completed NA study, sponsored by Ohio State University.

NCT04286321 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04286321, a NA study, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study 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. 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.

Primary Outcome

Area under the curve of deuterium-labeled phylloquinone

Interventions

  • OTHER Zero hard-boiled egg at 0 h
  • OTHER One hard-boiled egg at 0 h
  • OTHER Two hard-boiled eggs at 0 h
  • OTHER Three hard-boiled eggs at 0 h
  • OTHER One hard-boiled egg at 3 h

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-06-01
Est. Completion 2024-07-15
Phase NA
Ohio State University

552 total trials

What the finished NCT04286321 record still lists

NCT04286321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 5 interventions - of which Zero hard-boiled egg at 0 h is the first listed.

NCT04286321 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04286321 about?

NCT04286321 is a clinical study titled "Achieving Nutritional Adequacy Of Vitamin K With An Egg/Plant-Based Food Pairing". 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. ...

What is the current status of trial NCT04286321?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-06-01. Estimated completion is 2024-07-15.

What interventions are being tested in trial NCT04286321?

The interventions under investigation include: Zero hard-boiled egg at 0 h (OTHER), One hard-boiled egg at 0 h (OTHER), Two hard-boiled eggs at 0 h (OTHER), Three hard-boiled eggs at 0 h (OTHER), One hard-boiled egg at 3 h (OTHER).

Who is sponsoring clinical trial NCT04286321?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04286321's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04286321, the US trial registry maintained by the National Library of Medicine. NCT04286321 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.