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

NCT04286321 | Completed

• 1 other identifier: 2019H0504-B
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutritional Requirements

Keywords

Vitamin K; Egg; Spinach

Outcome Measures

Primary Outcomes (1)

• Vitamin K Bioavailability

  Area under the curve of deuterium-labeled phylloquinone

  0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach

Secondary Outcomes (5)

• Vitamin K Tmax

  0-72 hours post-ingestion of spinach

• Chylomicron Vitamin K

  0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach

• Estimated Absorption (%Dose) of Vitamin K

  0-72 hours post-ingestion of spinach

• Vitamin K Cmax

  0-72 hours post-ingestion of spinach

• Elimination Rate of Vitamin K

  0-72 hours post-ingestion of spinach

Study Arms (8)

Zero hard-boiled egg

EXPERIMENTAL

Deuterium-labeled spinach containing 500 μg PQ will be ingested alone prior to the 72-h pharmacokinetics trial.

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.

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.

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.

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.

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.

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.

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.

Other: Vegetable oil at 0 h

Interventions

Zero hard-boiled egg at 0 h OTHER

No eggs will be consumed on test day along with spinach consumption

Zero hard-boiled egg

One hard-boiled egg at 0 h OTHER

One egg will be consumed on test day along with spinach consumption

One hard-boiled egg at 0 h

Two hard-boiled eggs at 0 h OTHER

Two eggs will be consumed on test day along with spinach consumption

Two hard-boiled eggs at 0 h

Three hard-boiled eggs at 0 h OTHER

Three eggs will be consumed on test day along with spinach consumption

Three hard-boiled eggs at 0 h

One hard-boiled egg at 3 h OTHER

One egg will be consumed on test day three hours after spinach consumption

One hard-boiled egg at 3 h

One hard-boiled egg at 0 h + One hard-boiled egg at 3 h OTHER

Two eggs will be consumed on test day: one along with spinach consumption and the other one three hours after spinach consumption

One hard-boiled egg at 0 h + One hard-boiled egg at 3 h

Two egg whites at 0 h OTHER

Two egg whites will be consumed on test day along with spinach consumption

Two egg whites at 0 h

Vegetable oil at 0 h OTHER

9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption

Vegetable oil at 0 h

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No use of medications that affect lipid or glucose metabolism
• Non-smoker
• No history of gastrointestinal disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Bruno Lab

Columbus, Ohio, 43210, United States

Location

Study Officials

• Richard Bruno, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Principal Investigator

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 27, 2020
• Study Start: June 1, 2021
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

US (1)