Clinical trial NCT04287816: Achieving Nutritional Adequacy Of Vitamin E With An Egg/Plant-Based Food Pairing
Official title: Achieving Nutritional Adequacy Of Vitamin E With An Egg/Plant-Based Food Pairing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Requirements
Keywords: Vitamin E
Egg
Spinach
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 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. In Study Arm 7, participants will ingest spinach with two egg whites. In Study Arm 8, participants will ingest spinach with 9.6 grams of vegetable oil. Thus, Study Arms 1-4 will test the dose-dependent effects of eggs on αT bioavailability, Study Arms 5-6 (with comparison to Study Arms 1 and 2) will test the 'timing'-dependent effects of eggs on αT bioavailability, and Study Arms 7-8 will test the matrix effect 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin E Bioavailability
timeFrame: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Secondary outcomes:
measure: Vitamin E Tmax
timeFrame: 0-72 hours post-ingestion of spinach
measure: Chylomicron Vitamin E
timeFrame: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
measure: Elimination Rate of Vitamin E
timeFrame: 0-72 hours post-ingestion of spinach
measure: Estimated Absorption (%Dose) of Vitamin E
timeFrame: 0-72 hours post-ingestion of spinach
measure: Vitamin E Cmax
timeFrame: 0-72 hours post-ingestion of spinach
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Richard S Bruno, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: