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Completed

NCT Number: NCT04287816

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

Malnutrition of the fat-soluble nutrient vitamin E (α-tocopherol; αT) is problematic. Since αT is rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate αT 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 αT) to validate eggs as a dietary tool to improve αT 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 dose- and time-dependently increase plasma bioavailability of spinach-derived deuterium-labeled αT without affecting time to maximal concentrations or half-lives. Further, phospholipid-rich egg yolk lipid will enhance nutrient bioavailability compared with vegetable oil. The outcome will therefore support an egg-based food pairing that can enhance the health benefits of plant-centric dietary patterns.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

About this study

In the US, 92-96% of men and women do not meet recommended intakes for αT. Dietary recommendations strongly encourage a diet rich in fruits and vegetables to meet dietary αT requirements. However, αT 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 application is to use deuterium-labeled spinach (containing stable isotopes of αT) to validate eggs as a dietary tool to improve αT bioavailability directly from a model plant food, and hence achieve nutrient adequacy. Our hypothesis is that the bioavailability of αT 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 αT 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Zero hard-boiled egg at 0 h

Other

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

One hard-boiled egg at 0 h

Other

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

Two hard-boiled eggs at 0 h

Other

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

Three hard-boiled eggs at 0 h

Other

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

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 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

Two egg whites at 0 h

Other

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

Vegetable oil at 0 h

Other

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

Primary outcomes

  1. Vitamin E Area Under the Curve (0-72 h)

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

    Area under the concentration-time curve of plasma deuterium-labeled alpha-tocopherol over 72 hours post ingestion.

  2. Vitamin E Cmax

    Time frame: 0-72 hours post-ingestion of spinach

    Maximum plasma concentration of deuterium-labeled alpha-tocopherol

Secondary outcomes

  1. Vitamin E Tmax (hr)

    Time frame: 0-72 hours post-ingestion of spinach

    Time to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol

  2. Half-Life (hr)

    Time frame: 0-72 hours post-ingestion of spinach

    The time required for the plasma concentration of vitamin E to decrease by 50%.

  3. Estimated Absorption (%Dose) of Vitamin E

    Time frame: 0-72 hours post-ingestion of spinach

    Absorption of deuterium-labeled alpha-tocopherol

  4. Chylomicron Vitamin E

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

    Deuterium-labeled alpha-tocopherol concentration in chylomicron

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2020
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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