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

Sponsor

Ohio State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04287816

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Requirements	Other: Zero hard-boiled egg at 0 h Other: One hard-boiled egg at 0 h Other: Two hard-boiled eggs at 0 h Other: Three hard-boiled eggs at 0 h Other: One hard-boiled egg at 3 h Other: One hard-boiled egg at 0 h + One hard-boiled egg at 3 h	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zero hard-boiled egg at 0 h No eggs will be consumed on the test day. Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested alone prior to the 72-h pharmacokinetics trial.	Other: Zero hard-boiled egg at 0 h No eggs will be consumed on test day along with spinach consumption
Experimental: One hard-boiled egg at 0 h Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.	Other: One hard-boiled egg at 0 h One egg will be consumed on test day along with spinach consumption
Experimental: Two hard-boiled eggs at 0 h Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.	Other: Two hard-boiled eggs at 0 h Two eggs will be consumed on test day along with spinach consumption
Experimental: Three hard-boiled eggs at 0 h Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.	Other: Three hard-boiled eggs at 0 h Three eggs will be consumed on test day along with spinach consumption
Experimental: One hard-boiled egg at 3 h Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ 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.	Other: One hard-boiled egg at 3 h One egg will be consumed on test day three hours after spinach consumption
Experimental: One hard-boiled egg at 0 h + One hard-boiled egg at 3 h Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ 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.	Other: 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

Outcome Measures

Primary Outcome Measures

Vitamin E Bioavailability [0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach]
Area under the curve of deuterium-labeled alpha-tocopherol
Vitamin E Cmax [0-72 hours post-ingestion of spinach]
Maximum plasma concentration of deuterium-labeled alpha-tocopherol
Estimated Absorption (%Dose) of Vitamin E [0-72 hours post-ingestion of spinach]
Absorption of deuterium-labeled alpha-tocopherol
Vitamin K Bioavailability [0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach]
Area under the curve of deuterium-labeled phylloquinone
Vitamin K Cmax [0-72 hours post-ingestion of spinach]
Maximum plasma concentration of deuterium-labeled phylloquinone
Estimated Absorption (%Dose) of Vitamin K [0-72 hours post-ingestion of spinach]
Absorption of deuterium-labeled phylloquinone

Secondary Outcome Measures

Vitamin E Tmax [0-72 hours post-ingestion of spinach]
Time to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol
Chylomicron Vitamin E [0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach]
Deuterium-labeled alpha-tocopherol concentration in chylomicron
Elimination Rate of Vitamin E [0-72 hours post-ingestion of spinach]
Rate of plasma elimination of deuterium-labeled alpha-tocopherol
Vitamin K Tmax [0-72 hours post-ingestion of spinach]
Time to reach maximum plasma concentration of deuterium-labeled phylloquinone
Chylomicron Vitamin K [0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach]
Deuterium-labeled phylloquinone concentration in chylomicron
Elimination Rate of Vitamin K [0-72 hours post-ingestion of spinach]
Rate of plasma elimination of deuterium-labeled phylloquinone

Other Outcome Measures

Vitamin C [Prior to (0 hour) spinach consumption]
Baseline plasma vitamin C concentration
Malondialdehyde [Prior to (0 hour) spinach consumption]
Baseline plasma malondialdehyde concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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