Clinical Trials Logo

Clinical Trial Summary

Malnutrition of the fat-soluble nutrients vitamin E (α-tocopherol; αT) and vitamin K (phylloquinone; PQ) is problematic. Since αT and PQ are rich in plant foods (e.g. spinach) that are mostly absent of accessible lipid, dietary patterns that can potentiate αT and 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 αT and PQ) to validate eggs as a dietary tool to improve αT and 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 αT and 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.


Clinical Trial Description

In the US, 92-96% and 43-63% of men and women do not meet recommended intakes for αT and PQ, respectively. Dietary recommendations strongly encourage a diet rich in fruits and vegetables to meet dietary αT and PQ requirements. However, αT and 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 αT and PQ, and hence achieve nutrient adequacy. Our hypothesis is that phospholipid-rich whole eggs will enhance spinach-derived αT and PQ bioavailability compared with vegetable oil, and will be most functionally responsible for the benefits of eggs to enhance nutrient absorption. Further, 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 and PQ bioavailability by conducting a pharmacokinetic study in healthy men and women. Participants will ingest deuterium-labeled spinach (containing 2 mg αT and 500 μg PQ) alone (0 g fat), with two egg whites (0 g fat), 2 whole eggs (9.6 g fat), or vegetable oil (9.6 g fat) in a randomized cross-over design. Eucaloric diets will be controlled for αT and 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 αT and 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 α-T and 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 αT and PQ. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04286321
Study type Interventional
Source Ohio State University
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2021
Completion date August 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05489666 - Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females N/A
Completed NCT00803699 - Predicting Dietary Selenium Needs to Achieve Target Blood Selenium Levels N/A
Completed NCT03279315 - An Iodine Balance Experiment N/A
Recruiting NCT06074770 - Study on Dietary Intake Levels of Iodine for 3-6 Years Old Pre-school Children
Completed NCT00292812 - Clinical Effects of a Nucleotides-Supplemented Infant Formula N/A
Recruiting NCT04287816 - Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 1 N/A
Completed NCT04419103 - Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children
Recruiting NCT04492657 - Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
Not yet recruiting NCT05730803 - Displacement of Iodine Balance Value During Pregnancy and the Mechanism of Breast Iodine Homeostasis During Lactation