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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04287816
• Other study ID #: 2019H0504-A
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Richard S Bruno, Ph.D.
• Phone: 614-292-5522
• Email: bruno.27[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Requirements

Intervention

Other:
• Zero hard-boiled egg at 0 h
No eggs will be consumed on test day along with spinach consumption
• One hard-boiled egg at 0 h
One egg will be consumed on test day along with spinach consumption
• Two hard-boiled eggs at 0 h
Two eggs will be consumed on test day along with spinach consumption
• Three hard-boiled eggs at 0 h
Three eggs will be consumed on test day along with spinach consumption
• One hard-boiled egg at 3 h
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
Two eggs will be consumed on test day: one along with spinach consumption and the other one three hours after spinach consumption

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vitamin C	Baseline plasma vitamin C concentration	Prior to (0 hour) spinach consumption
Other	Malondialdehyde	Baseline plasma malondialdehyde concentration	Prior to (0 hour) spinach consumption
Primary	Vitamin E Bioavailability	Area under the curve of deuterium-labeled alpha-tocopherol	0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Primary	Vitamin E Cmax	Maximum plasma concentration of deuterium-labeled alpha-tocopherol	0-72 hours post-ingestion of spinach
Primary	Estimated Absorption (%Dose) of Vitamin E	Absorption of deuterium-labeled alpha-tocopherol	0-72 hours post-ingestion of spinach
Primary	Vitamin K Bioavailability	Area under the curve of deuterium-labeled phylloquinone	0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Primary	Vitamin K Cmax	Maximum plasma concentration of deuterium-labeled phylloquinone	0-72 hours post-ingestion of spinach
Primary	Estimated Absorption (%Dose) of Vitamin K	Absorption of deuterium-labeled phylloquinone	0-72 hours post-ingestion of spinach
Secondary	Vitamin E Tmax	Time to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol	0-72 hours post-ingestion of spinach
Secondary	Chylomicron Vitamin E	Deuterium-labeled alpha-tocopherol concentration in chylomicron	0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
Secondary	Elimination Rate of Vitamin E	Rate of plasma elimination of deuterium-labeled alpha-tocopherol	0-72 hours post-ingestion of spinach
Secondary	Vitamin K Tmax	Time to reach maximum plasma concentration of deuterium-labeled phylloquinone	0-72 hours post-ingestion of spinach
Secondary	Chylomicron Vitamin K	Deuterium-labeled phylloquinone concentration in chylomicron	0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
Secondary	Elimination Rate of Vitamin K	Rate of plasma elimination of deuterium-labeled phylloquinone	0-72 hours post-ingestion of spinach