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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04286321
Other study ID # 2019H0504-B
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date August 2024

Study information

Verified date February 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
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 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Zero hard-boiled egg
No eggs will be consumed on test day
Two egg whites
Two egg whites will be consumed on test day
Two hard-boiled eggs
Two eggs will be consumed on test day
Vegetable oil
Vegetable oil will be consumed on test day

Locations

Country Name City State
United States Bruno Lab 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
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