- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286321
Achieving Nutritional Adequacy Of Vitamins E and K With An Egg/Plant-Based Food Pairing - Study 2
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Richard S Bruno
- Phone Number: 614-292-5522
- Email: bruno.27@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Bruno Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
Vegetable oil will be consumed on test day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin E Bioavailability
Time Frame: 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
|
0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
|
Vitamin E Cmax
Time Frame: 0-72 hours post-ingestion of spinach
|
Maximum plasma concentration of deuterium-labeled alpha-tocopherol
|
0-72 hours post-ingestion of spinach
|
Estimated Absorption (%Dose) of Vitamin E
Time Frame: 0-72 hours post-ingestion of spinach
|
Absorption of deuterium-labeled alpha-tocopherol
|
0-72 hours post-ingestion of spinach
|
Vitamin K Bioavailability
Time Frame: 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
|
0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
|
Vitamin K Cmax
Time Frame: 0-72 hours post-ingestion of spinach
|
Maximum plasma concentration of deuterium-labeled phylloquinone
|
0-72 hours post-ingestion of spinach
|
Estimated Absorption (%Dose) of Vitamin K
Time Frame: 0-72 hours post-ingestion of spinach
|
Absorption of deuterium-labeled phylloquinone
|
0-72 hours post-ingestion of spinach
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin E Tmax
Time Frame: 0-72 hours post-ingestion of spinach
|
Time to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol
|
0-72 hours post-ingestion of spinach
|
Chylomicron Vitamin E
Time Frame: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
|
Deuterium-labeled alpha-tocopherol concentration in chylomicron
|
0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
|
Elimination Rate of Vitamin E
Time Frame: 0-72 hours post-ingestion of spinach
|
Rate of plasma elimination of deuterium-labeled alpha-tocopherol
|
0-72 hours post-ingestion of spinach
|
Vitamin K Tmax
Time Frame: 0-72 hours post-ingestion of spinach
|
Time to reach maximum plasma concentration of deuterium-labeled phylloquinone
|
0-72 hours post-ingestion of spinach
|
Chylomicron Vitamin K
Time Frame: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
|
Deuterium-labeled phylloquinone concentration in chylomicron
|
0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinach
|
Elimination Rate of Vitamin K
Time Frame: 0-72 hours post-ingestion of spinach
|
Rate of plasma elimination of deuterium-labeled phylloquinone
|
0-72 hours post-ingestion of spinach
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin C
Time Frame: Prior to (0 hour) spinach consumption
|
Baseline plasma vitamin C concentration
|
Prior to (0 hour) spinach consumption
|
Malondialdehyde
Time Frame: Prior to (0 hour) spinach consumption
|
Baseline plasma malondialdehyde concentration
|
Prior to (0 hour) spinach consumption
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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