Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 2

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04286321
Collaborator
(none)
10
1
4
18
0.6

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Zero hard-boiled egg
  • Other: Two egg whites
  • Other: Two hard-boiled eggs
  • Other: Vegetable oil
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 study is to demonstrate that an effective food pairing of spinach with phospholipid lipid-rich eggs promotes intestinal absorption of spinach-derived αT and PQ, and hence achieve nutrient adequacy. Our hypothesis is that phospholipid-rich whole eggs will enhance spinach-derived αT and PQ bioavailability compared with vegetable oil, and will be most functionally responsible for the benefits of eggs to enhance nutrient absorption. Further, 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 and PQ bioavailability by conducting a pharmacokinetic study in healthy men and women. Participants will ingest deuterium-labeled spinach (containing 2 mg αT and 500 μg PQ) alone (0 g fat), with two egg whites (0 g fat), 2 whole eggs (9.6 g fat), or vegetable oil (9.6 g fat) in a randomized cross-over design. 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 establish that egg lipids substantially enhance plant-derived α-T and PQ bioavailability (based on AUC0-72 h, Cmax, and % estimated absorption) independent of any changes in oxidative distress.

The rationale for this study is that, by establishing the efficacy of eggs and egg yolk lipids 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 2
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

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
No eggs will be consumed on test day

Experimental: Two egg whites

Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested with two egg whites (0 g fat) prior to the 72-h pharmacokinetics trial.

Other: Two egg whites
Two egg whites will be consumed on test day

Experimental: Two hard-boiled eggs

Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested with two whole eggs (9.6 g fat) prior to the 72-h pharmacokinetics trial.

Other: Two hard-boiled eggs
Two eggs will be consumed on test day

Experimental: Vegetable oil

Deuterium-labeled spinach containing 2 mg αT and 500 ug PQ will be ingested with vegetable oil (9.6 g fat) prior to the 72-h pharmacokinetics trial.

Other: Vegetable oil
Vegetable oil will be consumed on test day

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Vitamin E Cmax [0-72 hours post-ingestion of spinach]

    Maximum plasma concentration of deuterium-labeled alpha-tocopherol

  3. Estimated Absorption (%Dose) of Vitamin E [0-72 hours post-ingestion of spinach]

    Absorption of deuterium-labeled alpha-tocopherol

  4. 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

  5. Vitamin K Cmax [0-72 hours post-ingestion of spinach]

    Maximum plasma concentration of deuterium-labeled phylloquinone

  6. Estimated Absorption (%Dose) of Vitamin K [0-72 hours post-ingestion of spinach]

    Absorption of deuterium-labeled phylloquinone

Secondary Outcome Measures

  1. Vitamin E Tmax [0-72 hours post-ingestion of spinach]

    Time to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol

  2. Chylomicron Vitamin E [0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach]

    Deuterium-labeled alpha-tocopherol concentration in chylomicron

  3. Elimination Rate of Vitamin E [0-72 hours post-ingestion of spinach]

    Rate of plasma elimination of deuterium-labeled alpha-tocopherol

  4. Vitamin K Tmax [0-72 hours post-ingestion of spinach]

    Time to reach maximum plasma concentration of deuterium-labeled phylloquinone

  5. Chylomicron Vitamin K [0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach]

    Deuterium-labeled phylloquinone concentration in chylomicron

  6. Elimination Rate of Vitamin K [0-72 hours post-ingestion of spinach]

    Rate of plasma elimination of deuterium-labeled phylloquinone

Other Outcome Measures

  1. Vitamin C [Prior to (0 hour) spinach consumption]

    Baseline plasma vitamin C concentration

  2. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bruno Lab Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Richard Bruno, Professor and Principal Investigator, Ohio State University
ClinicalTrials.gov Identifier:
NCT04286321
Other Study ID Numbers:
  • 2019H0504-B
First Posted:
Feb 27, 2020
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard Bruno, Professor and Principal Investigator, Ohio State University

Study Results

No Results Posted as of Dec 20, 2021