Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 1

Nutritional Requirements Clinical Trial

Official title: Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 1

Status Recruiting

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 dose- and time-dependently increase plasma bioavailability of spinach-derived deuterium-labeled αT and PQ without affecting time to maximal concentrations or half-lives. The outcome will therefore support an egg-based food pairing that can enhance the health benefits of plant-centric dietary patterns.

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 application 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. Our hypothesis is that the bioavailability of αT and PQ from deuterium-labeled spinach will be potentiated by egg intake in a dose-dependent manner by increasing their secretion in intestinal-derived chylomicrons.

To test this, our specific aim is to assess egg-mediated improvements in αT and PQ bioavailability by conducting a randomized cross-over pharmacokinetic study in healthy men and women. In Study Arms 1-4, participants will ingest deuterium-labeled spinach (containing 2 mg αT and 500 μg PQ) 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 alone followed by 1 egg 3-hours later. In Study Arm 6, participants will ingest spinach with 1 egg followed by another egg 3-hours later. Thus, Study Arms 1-4 will test the dose-dependent effects of eggs on nutrient bioavailability and Study Arms 5-6 (with comparison to Study Arms 1 and 2) will test the 'timing'-dependent effects of eggs on nutrient bioavailability. 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 demonstrate a dose- and time-dependent function of eggs to increase deuterium-labeled αT and PQ bioavailability (based on AUC0-72 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 and PQ. ;

Related Conditions & MeSH terms

• Nutritional Requirements

• NCT number: NCT04287816
• Study type: Interventional
• Source: Ohio State University
• Contact: Richard S Bruno, Ph.D.
• Phone: 614-292-5522
• Email: bruno.27@osu.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Completion date: August 2024