Achieving Nutritional Adequacy Of Vitamin E With An Egg/Plant-Based Food Pairing
NCT ID: NCT04287816
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2021-06-01
2024-07-15
Brief Summary
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Detailed Description
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To test this, our specific aim is to assess egg-mediated improvements in αT 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 5 mg αT) 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 with two egg whites. In Study Arm 6, participants will ingest spinach with 9.6 grams of vegetable oil. In Study Arm 5, participants will ingest spinach alone followed by 1 egg 3-hours later. In Study Arm 7, participants will ingest spinach with 1 egg followed by another egg 3-hours later. In Study Arm 8, participants will ingest spinach with 1 egg followed by another egg 3-hours later. Thus, Study Arms 1-6 will test the dose-dependent and food matrix effects of eggs on αT bioavailability, and study Arms 7-8 will test the meal timing effects of eggs on αT bioavailability. Eucaloric diets will be controlled for αT 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 αT 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 demonstrate a dose- and time-dependent function of eggs to increase deuterium-labeled αT bioavailability (based on area under the curve (AUC) 0-72 h, Cmax, and % estimated absorption).
The rationale for this study is that, by establishing the efficacy of eggs 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 αT.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Zero hard-boiled egg at 0 h
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg αT will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h
No eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 0 h
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h
One egg will be consumed on test day along with spinach consumption
Two hard-boiled eggs at 0 h
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h
Two eggs will be consumed on test day along with spinach consumption
Three hard-boiled eggs at 0 h
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h
Three eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 3 h
Deuterium-labeled spinach containing 5 mg αT will be ingested alone at 0 h prior to the 72-h pharmacokinetics trial followed by 1 hard-boiled egg 3 hours after spinach consumption.
One hard-boiled egg at 3 h
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 h
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg at 0 h prior to the 72-h pharmacokinetics trial followed by 1 egg 3 hours after spinach consumption.
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
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 h
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h
Two egg whites will be consumed on test day along with spinach consumption
Vegetable oil at 0 h
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h
9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
Interventions
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Vegetable oil at 0 h
9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
Zero hard-boiled egg at 0 h
No eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 0 h
One egg will be consumed on test day along with spinach consumption
Two hard-boiled eggs at 0 h
Two eggs will be consumed on test day along with spinach consumption
Three hard-boiled eggs at 0 h
Three eggs will be consumed on test day along with spinach consumption
One hard-boiled egg at 3 h
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 h
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 h
Two egg whites will be consumed on test day along with spinach consumption
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Responsible Party
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Richard Bruno
Professor and Principal Investigator
Principal Investigators
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Richard S Bruno, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2019H0504-A
Identifier Type: -
Identifier Source: org_study_id
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