Trial Outcomes & Findings for Achieving Nutritional Adequacy Of Vitamin E With An Egg/Plant-Based Food Pairing (NCT NCT04287816)
NCT ID: NCT04287816
Last Updated: 2025-12-02
Results Overview
Area under the concentration-time curve of plasma deuterium-labeled alpha-tocopherol over 72 hours post ingestion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinach
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
Sequence 1
Participants received the following interventions in order across 8 periods:
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
Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
|
Sequence 2
Participants received one of the interventions listed in the periods. One hard-boiled egg at 0 h
Two hard-boiled eggs at 0 h
Three hard-boiled eggs at 0 h
Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
Zero hard-boiled egg at 0 h
|
Sequence 3
Participants received one of the interventions listed in the periods. Two hard-boiled eggs at 0 h
Three hard-boiled eggs at 0 h
Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
Zero hard-boiled egg at 0 h
One hard-boiled egg at 0 h
|
Sequence 4
Participants received one of the interventions listed in the periods. Three hard-boiled eggs at 0 h
Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
Zero hard-boiled egg at 0 h
One hard-boiled egg at 0 h
Two hard-boiled eggs at 0 h
|
Sequence 5
Participants received one of the interventions listed in the periods. Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
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
|
Sequence 6
Participants received one of the interventions listed in the periods. Vegetable oil at 0 h
One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
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
Two egg whites at 0 h
|
Sequence 7
Participants received one of the interventions listed in the periods. One hard-boiled egg at 3 h
One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
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
Two egg whites at 0 h
Vegetable oil at 0 h
|
Sequence 8
Participants received one of the interventions listed in the periods. One hard-boiled egg at 0 h + One hard-boiled egg at 3 h
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
Two egg whites at 0 h
Vegetable oil at 0 h
One hard-boiled egg at 3 h
|
|---|---|---|---|---|---|---|---|---|
|
SPINACH
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Washout (1 Week)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + 1 Egg (0 h)
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 1 Egg (0 h)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 1 Egg (0 h)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + 2 Eggs (0 h)
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 2 Eggs (0 h)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 2 Eggs (0 h)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + 3 Eggs (0 h)
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 3 Eggs (0 h)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + 3 Eggs (0 h)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + WHITE
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + WHITE
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + WHITE
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + Oil
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + Oil
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
SPINACH + Oil
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + Egg (3 h)
STARTED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
SPINACH + Egg (3 h)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
SPINACH + Egg (3 h)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SPINACH + Eggs (0 & 3 h)
STARTED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
SPINACH + Eggs (0 & 3 h)
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
|
SPINACH + Eggs (0 & 3 h)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline Characteristics
n=8 Participants
Characteristics of participants upon enrollment into the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
|
Body Mass Index
|
21.8 kg/m^2
STANDARD_DEVIATION 2.0 • n=8 Participants
|
|
Waist circumference Male
|
76.3 cm
STANDARD_DEVIATION 4.2 • n=8 Participants
|
|
Waist circumference Female
|
74.1 cm
STANDARD_DEVIATION 4.6 • n=8 Participants
|
|
Systolic blood pressure
|
109.6 mmHg
STANDARD_DEVIATION 8.3 • n=8 Participants
|
|
Diastolic blood pressure
|
70.8 mmHg
STANDARD_DEVIATION 5.4 • n=8 Participants
|
|
Total Cholesterol
|
4.19 mmol/L
STANDARD_DEVIATION 0.47 • n=8 Participants
|
|
Triglyceride
|
0.57 mmol/L
STANDARD_DEVIATION 0.15 • n=8 Participants
|
|
Total Lipid
|
4.75 mmol/L
STANDARD_DEVIATION 0.57 • n=8 Participants
|
|
Glucose
|
4.81 mmol/L
STANDARD_DEVIATION 0.39 • n=8 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 4.5, 6, 7.5, 9, 12, 24, 36, 48, 72 hours post-ingestion of spinachArea under the concentration-time curve of plasma deuterium-labeled alpha-tocopherol over 72 hours post ingestion.
Outcome measures
| Measure |
SPINACH + 1 EGG0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h: One egg will be consumed on test day along with spinach consumption
|
SPINACH + 2 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h: Two eggs will be consumed on test day along with spinach consumption
|
SPINACH + 3 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h: Three eggs will be consumed on test day along with spinach consumption
|
SPINACH
n=8 Participants
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg alpha-tocopherol (αT) will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h: No eggs will be consumed on test day along with spinach consumption
|
SPINACH + WHITE
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h: Two egg whites will be consumed on test day along with spinach consumption
|
SPINACH + OIL
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h: 9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
|
SPINACH + EGG3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
One hard-boiled egg at 3 h: One egg will be consumed on test day three hours after spinach consumption
|
SPINACH + EGGS0 & 3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
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
|
|---|---|---|---|---|---|---|---|---|
|
Vitamin E Area Under the Curve (0-72 h)
|
5.24 umol/L*h
Standard Error 1.00
|
5.18 umol/L*h
Standard Error 1.06
|
4.39 umol/L*h
Standard Error 0.69
|
2.90 umol/L*h
Standard Error 0.88
|
5.10 umol/L*h
Standard Error 0.65
|
6.88 umol/L*h
Standard Error 0.74
|
1.67 umol/L*h
Standard Error 0.45
|
4.88 umol/L*h
Standard Error 1.53
|
PRIMARY outcome
Timeframe: 0-72 hours post-ingestion of spinachMaximum plasma concentration of deuterium-labeled alpha-tocopherol
Outcome measures
| Measure |
SPINACH + 1 EGG0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h: One egg will be consumed on test day along with spinach consumption
|
SPINACH + 2 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h: Two eggs will be consumed on test day along with spinach consumption
|
SPINACH + 3 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h: Three eggs will be consumed on test day along with spinach consumption
|
SPINACH
n=8 Participants
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg alpha-tocopherol (αT) will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h: No eggs will be consumed on test day along with spinach consumption
|
SPINACH + WHITE
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h: Two egg whites will be consumed on test day along with spinach consumption
|
SPINACH + OIL
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h: 9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
|
SPINACH + EGG3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
One hard-boiled egg at 3 h: One egg will be consumed on test day three hours after spinach consumption
|
SPINACH + EGGS0 & 3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
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
|
|---|---|---|---|---|---|---|---|---|
|
Vitamin E Cmax
|
0.18 umol/L
Standard Error 0.03
|
0.15 umol/L
Standard Error 0.03
|
0.14 umol/L
Standard Error 0.02
|
0.09 umol/L
Standard Error 0.02
|
0.15 umol/L
Standard Error 0.02
|
0.2 umol/L
Standard Error 0.02
|
0.06 umol/L
Standard Error 0.01
|
0.14 umol/L
Standard Error 0.04
|
SECONDARY outcome
Timeframe: 0-72 hours post-ingestion of spinachTime to reach maximum plasma concentration of deuterium-labeled alpha-tocopherol
Outcome measures
| Measure |
SPINACH + 1 EGG0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h: One egg will be consumed on test day along with spinach consumption
|
SPINACH + 2 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h: Two eggs will be consumed on test day along with spinach consumption
|
SPINACH + 3 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h: Three eggs will be consumed on test day along with spinach consumption
|
SPINACH
n=8 Participants
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg alpha-tocopherol (αT) will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h: No eggs will be consumed on test day along with spinach consumption
|
SPINACH + WHITE
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h: Two egg whites will be consumed on test day along with spinach consumption
|
SPINACH + OIL
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h: 9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
|
SPINACH + EGG3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
One hard-boiled egg at 3 h: One egg will be consumed on test day three hours after spinach consumption
|
SPINACH + EGGS0 & 3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
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
|
|---|---|---|---|---|---|---|---|---|
|
Vitamin E Tmax (hr)
|
10.10 hr
Standard Error 0.55
|
10.90 hr
Standard Error 0.55
|
9.94 hr
Standard Error 0.63
|
9.64 hr
Standard Error 0.86
|
9.94 hr
Standard Error 0.63
|
9.38 hr
Standard Error 0.79
|
10.20 hr
Standard Error 0.74
|
9.90 hr
Standard Error 0.90
|
SECONDARY outcome
Timeframe: 0-72 hours post-ingestion of spinachThe time required for the plasma concentration of vitamin E to decrease by 50%.
Outcome measures
| Measure |
SPINACH + 1 EGG0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h: One egg will be consumed on test day along with spinach consumption
|
SPINACH + 2 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h: Two eggs will be consumed on test day along with spinach consumption
|
SPINACH + 3 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h: Three eggs will be consumed on test day along with spinach consumption
|
SPINACH
n=8 Participants
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg alpha-tocopherol (αT) will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h: No eggs will be consumed on test day along with spinach consumption
|
SPINACH + WHITE
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h: Two egg whites will be consumed on test day along with spinach consumption
|
SPINACH + OIL
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h: 9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
|
SPINACH + EGG3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
One hard-boiled egg at 3 h: One egg will be consumed on test day three hours after spinach consumption
|
SPINACH + EGGS0 & 3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
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
|
|---|---|---|---|---|---|---|---|---|
|
Half-Life (hr)
|
22.52 hr
Standard Error 3.26
|
26.92 hr
Standard Error 2.25
|
24.34 hr
Standard Error 3.65
|
25.36 hr
Standard Error 4.54
|
26.79 hr
Standard Error 1.57
|
30.45 hr
Standard Error 2.11
|
16.89 hr
Standard Error 2.53
|
21.24 hr
Standard Error 5.37
|
SECONDARY outcome
Timeframe: 0-72 hours post-ingestion of spinachAbsorption of deuterium-labeled alpha-tocopherol
Outcome measures
| Measure |
SPINACH + 1 EGG0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 1 hard-boiled egg prior to the 72-h pharmacokinetics trial.
One hard-boiled egg at 0 h: One egg will be consumed on test day along with spinach consumption
|
SPINACH + 2 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5mg αT will be ingested along with 2 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Two hard-boiled eggs at 0 h: Two eggs will be consumed on test day along with spinach consumption
|
SPINACH + 3 EGGS0 h
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 3 hard-boiled eggs prior to the 72-h pharmacokinetics trial.
Three hard-boiled eggs at 0 h: Three eggs will be consumed on test day along with spinach consumption
|
SPINACH
n=8 Participants
No eggs will be consumed on the test day. Deuterium-labeled spinach containing 5 mg alpha-tocopherol (αT) will be ingested alone prior to the 72-h pharmacokinetics trial.
Zero hard-boiled egg at 0 h: No eggs will be consumed on test day along with spinach consumption
|
SPINACH + WHITE
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with two egg whites prior to the 72-h pharmacokinetics trial.
Two egg whites at 0 h: Two egg whites will be consumed on test day along with spinach consumption
|
SPINACH + OIL
n=8 Participants
Deuterium-labeled spinach containing 5 mg αT will be ingested along with 9.6 grams of vegetable oil prior to the 72-h pharmacokinetics trial.
Vegetable oil at 0 h: 9.6 grams of Vegetable oil will be consumed on test day along with spinach consumption
|
SPINACH + EGG3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
One hard-boiled egg at 3 h: One egg will be consumed on test day three hours after spinach consumption
|
SPINACH + EGGS0 & 3 h
n=5 Participants
Deuterium-labeled spinach containing 5 mg αT 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.
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
|
|---|---|---|---|---|---|---|---|---|
|
Estimated Absorption (%Dose) of Vitamin E
|
3.52 Percent
Standard Error 0.46
|
2.95 Percent
Standard Error 0.53
|
2.96 Percent
Standard Error 0.44
|
1.93 Percent
Standard Error 0.50
|
3.02 Percent
Standard Error 0.44
|
3.86 Percent
Standard Error 0.43
|
1.10 Percent
Standard Error 0.22
|
2.70 Percent
Standard Error 0.73
|
SECONDARY outcome
Timeframe: 0, 3, 4.5, 6, 7.5, 9, 12 hours post-ingestion of spinachPopulation: Chylomicron measurements of vitamin E content were initially planned as part of the study protocol. While chylomicrons were isolated from blood samples and cryopreserved during the intervention, sample analysis was not performed because resources and personnel became unavailable. No data are available and these measures are not anticipated to be completed.
Deuterium-labeled alpha-tocopherol concentration in chylomicron
Outcome measures
Outcome data not reported
Adverse Events
Primary Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exploratory Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place