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Egg/Plant-Based Food Pairing for Nutritional Requirements

N/A
Recruiting
Led By Richard S Bruno, Ph.D.
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Awards & highlights

Study Summary

This trial is testing whether eggs can help improve the absorption of nutrients from spinach.

Who is the study for?
This trial is for adults with normal blood and cholesterol levels, fasting glucose under 100 mg/dL, BMI between 19-25, and non-smokers. They shouldn't be on meds affecting lipid/glucose metabolism or supplements recently, have no gut disorders or egg allergies, not pregnant/lactating/changed birth control recently, don't drink heavily or exercise excessively.Check my eligibility
What is being tested?
The study tests how well eating eggs with spinach boosts the body's levels of vitamins E (α-tocopherol) and K (phylloquinone). Participants will eat a set number of hard-boiled eggs at specific times to see if it helps absorb these nutrients from spinach better.See study design
What are the potential side effects?
Since this trial involves common foods like eggs and spinach without any experimental drugs involved, significant side effects are unlikely. However, digestive discomfort could occur due to dietary changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimated Absorption (%Dose) of Vitamin E
Vitamin K
Vitamin E Bioavailability
+3 more
Secondary outcome measures
Chylomicron Vitamin E
Chylomicron Vitamin K
Elimination Rate of Vitamin E
+3 more
Other outcome measures
Malondialdehyde
Vitamin C

Trial Design

6Treatment groups
Experimental Treatment
Group I: Zero hard-boiled egg at 0 hExperimental Treatment1 Intervention
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.
Group II: Two hard-boiled eggs at 0 hExperimental Treatment1 Intervention
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.
Group III: Three hard-boiled eggs at 0 hExperimental Treatment1 Intervention
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.
Group IV: One hard-boiled egg at 3 hExperimental Treatment1 Intervention
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.
Group V: One hard-boiled egg at 0 h + One hard-boiled egg at 3 hExperimental Treatment1 Intervention
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.
Group VI: One hard-boiled egg at 0 hExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,733 Total Patients Enrolled
1 Trials studying Nutritional Requirements
10 Patients Enrolled for Nutritional Requirements
Richard S Bruno, Ph.D.Principal InvestigatorOhio State University

Media Library

Egg/Plant-Based Food Pairing Clinical Trial Eligibility Overview. Trial Name: NCT04287816 — N/A
Nutritional Requirements Research Study Groups: Zero hard-boiled egg at 0 h, One hard-boiled egg at 0 h, Two hard-boiled eggs at 0 h, Three hard-boiled eggs at 0 h, One hard-boiled egg at 3 h, One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
Nutritional Requirements Clinical Trial 2023: Egg/Plant-Based Food Pairing Highlights & Side Effects. Trial Name: NCT04287816 — N/A
Egg/Plant-Based Food Pairing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04287816 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 1
Richard Bruno 2021. "Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04287816.
~1 spots leftby Aug 2024
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