Trial Outcomes & Findings for Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (NCT NCT03039023)
NCT ID: NCT03039023
Last Updated: 2025-11-04
Results Overview
Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.
COMPLETED
NA
86 participants
Baseline, 28 days
2025-11-04
Participant Flow
Participant milestones
| Measure |
Whole Hardboiled Eggs
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Choline Bitartrate Tablets
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Hardboiled Eggs + Choline Bitartrate Tablets
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
17
|
20
|
10
|
|
Overall Study
COMPLETED
|
18
|
20
|
16
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Whole Hardboiled Eggs
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Choline Bitartrate Tablets
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Hardboiled Eggs + Choline Bitartrate Tablets
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans
Baseline characteristics by cohort
| Measure |
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.5 years
n=15 Participants
|
27.0 years
n=161 Participants
|
37.0 years
n=100 Participants
|
30.0 years
n=3 Participants
|
31.5 years
n=8 Participants
|
28.0 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=15 Participants
|
9 Participants
n=161 Participants
|
15 Participants
n=100 Participants
|
10 Participants
n=3 Participants
|
6 Participants
n=8 Participants
|
48 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
11 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
8 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
34 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=15 Participants
|
15 Participants
n=161 Participants
|
16 Participants
n=100 Participants
|
16 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
67 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=15 Participants
|
20 Participants
n=161 Participants
|
16 Participants
n=100 Participants
|
18 Participants
n=3 Participants
|
10 Participants
n=8 Participants
|
82 Participants
n=7 Participants
|
|
TMAO at Baseline
|
2.0 uM
n=15 Participants
|
1.9 uM
n=161 Participants
|
2.3 uM
n=100 Participants
|
2.6 uM
n=3 Participants
|
2.8 uM
n=8 Participants
|
2.3 uM
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 28 daysPopulation: All participants with TMAO measured at baseline and Day 28.
Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
Baseline
|
1.9 uM
Interval 1.4 to 3.4
|
2.0 uM
Interval 1.4 to 3.5
|
2.3 uM
Interval 1.5 to 2.8
|
2.6 uM
Interval 1.8 to 5.3
|
2.8 uM
Interval 2.0 to 5.1
|
|
Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
Day 28
|
11.1 uM
Interval 7.1 to 25.4
|
2.3 uM
Interval 1.9 to 3.7
|
12.3 uM
Interval 5.1 to 26.5
|
28.1 uM
Interval 9.2 to 44.1
|
3.4 uM
Interval 2.6 to 7.1
|
PRIMARY outcome
Timeframe: Baseline, Day 28The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=10 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=10 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=10 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=9 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Platelet Function With Increased Choline Intake
Baseline
|
2.6 aggregation percentage
Interval 1.2 to 7.2
|
2.6 aggregation percentage
Interval 1.4 to 5.3
|
2.3 aggregation percentage
Interval 1.6 to 3.0
|
3.0 aggregation percentage
Interval 2.3 to 5.0
|
2.8 aggregation percentage
Interval 2.0 to 4.0
|
|
Changes in Platelet Function With Increased Choline Intake
Day 28
|
12.8 aggregation percentage
Interval 7.6 to 27.2
|
3.6 aggregation percentage
Interval 2.5 to 7.7
|
12.3 aggregation percentage
Interval 6.1 to 25.7
|
29.4 aggregation percentage
Interval 17.9 to 43.3
|
3.4 aggregation percentage
Interval 2.6 to 7.1
|
SECONDARY outcome
Timeframe: Baseline, Day 28Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=19 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections
Day 28
|
139.0 mg in 24 hours
Interval 90.1 to 308.9
|
28.5 mg in 24 hours
Interval 23.1 to 36.7
|
221.8 mg in 24 hours
Interval 166.3 to 294.3
|
186.9 mg in 24 hours
Interval 91.2 to 232.4
|
33.1 mg in 24 hours
Interval 19.9 to 64.6
|
|
Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections
Baseline
|
26.2 mg in 24 hours
Interval 15.6 to 40.3
|
24.3 mg in 24 hours
Interval 13.0 to 44.3
|
27.5 mg in 24 hours
Interval 9.1 to 36.2
|
29.3 mg in 24 hours
Interval 18.4 to 45.9
|
15.8 mg in 24 hours
Interval 12.9 to 35.6
|
SECONDARY outcome
Timeframe: Baseline, Day 28Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Plasma Levels of Fasting Choline
Baseline
|
7.5 uM
Interval 6.5 to 9.3
|
8.3 uM
Interval 6.6 to 10.2
|
8.5 uM
Interval 7.6 to 11.2
|
9.5 uM
Interval 7.6 to 11.6
|
7.6 uM
Interval 6.7 to 9.1
|
|
Changes in Plasma Levels of Fasting Choline
Day 28
|
12.9 uM
Interval 10.8 to 16.0
|
10.9 uM
Interval 8.9 to 12.4
|
14.0 uM
Interval 11.7 to 15.7
|
12.8 uM
Interval 10.2 to 14.1
|
10.6 uM
Interval 9.2 to 11.6
|
SECONDARY outcome
Timeframe: Baseline, Day 28Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Plasma Levels of Fasting Carnitine.
Baseline
|
21.2 uM
Interval 16.6 to 25.1
|
19.1 uM
Interval 16.3 to 22.8
|
21.5 uM
Interval 16.8 to 24.8
|
21.1 uM
Interval 16.5 to 26.6
|
23.4 uM
Interval 17.8 to 28.1
|
|
Changes in Plasma Levels of Fasting Carnitine.
Day 28
|
18.7 uM
Interval 15.5 to 21.0
|
19.4 uM
Interval 13.4 to 27.9
|
15.6 uM
Interval 10.9 to 19.4
|
18.9 uM
Interval 15.2 to 23.2
|
20.8 uM
Interval 19.1 to 27.5
|
SECONDARY outcome
Timeframe: Baseline, Day 28Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Plasma Levels of Fasting Betaine.
Baseline
|
38.2 uM
Interval 28.7 to 48.7
|
28.1 uM
Interval 23.6 to 48.3
|
30.7 uM
Interval 18.4 to 35.7
|
38.7 uM
Interval 23.3 to 47.7
|
33.6 uM
Interval 23.3 to 45.0
|
|
Changes in Plasma Levels of Fasting Betaine.
Day 28
|
69.0 uM
Interval 54.4 to 82.2
|
39.7 uM
Interval 29.4 to 55.5
|
46.9 uM
Interval 33.9 to 67.5
|
59.8 uM
Interval 41.6 to 65.6
|
46.3 uM
Interval 28.3 to 64.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28Changes in total cholesterol levels between baseline and Day 28
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Lipid Profile, Total Cholesterol
Day 28
|
172 mg/dL
Interval 157.0 to 191.0
|
158 mg/dL
Interval 136.0 to 180.0
|
198 mg/dL
Interval 168.0 to 221.0
|
178 mg/dL
Interval 157.0 to 193.0
|
172 mg/dL
Interval 151.0 to 213.0
|
|
Changes in Lipid Profile, Total Cholesterol
Baseline
|
180 mg/dL
Interval 147.0 to 201.0
|
156 mg/dL
Interval 145.0 to 175.0
|
187 mg/dL
Interval 172.0 to 204.0
|
186 mg/dL
Interval 150.0 to 189.0
|
175 mg/dL
Interval 159.0 to 217.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28Changes in measured HDL levels between baseline and Day 28
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Lipid Profile, HDL
Baseline
|
49 mg/dL
Interval 40.0 to 60.0
|
48 mg/dL
Interval 44.0 to 66.0
|
57 mg/dL
Interval 50.0 to 65.0
|
48 mg/dL
Interval 39.0 to 63.0
|
61 mg/dL
Interval 49.0 to 65.0
|
|
Changes in Lipid Profile, HDL
Day 28
|
51 mg/dL
Interval 44.0 to 60.0
|
49 mg/dL
Interval 44.0 to 65.0
|
56 mg/dL
Interval 49.0 to 74.0
|
50 mg/dL
Interval 41.0 to 57.0
|
62 mg/dL
Interval 42.0 to 64.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28Changes in measured LDL levels between baseline and Day 28
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Lipid Profile, LDL
Day 28
|
94 mg/dL
Interval 82.0 to 119.0
|
86 mg/dL
Interval 71.0 to 110.0
|
118 mg/dL
Interval 87.0 to 132.0
|
101 mg/dL
Interval 87.0 to 121.0
|
106 mg/dL
Interval 79.0 to 136.0
|
|
Changes in Lipid Profile, LDL
Baseline
|
90 mg/dL
Interval 80.0 to 124.0
|
91 mg/dL
Interval 72.0 to 102.0
|
108 mg/dL
Interval 98.0 to 120.0
|
104 mg/dL
Interval 86.0 to 124.0
|
107 mg/dL
Interval 90.0 to 137.0
|
SECONDARY outcome
Timeframe: Baseline, Day 28Changes in measured triglyceride levels between baseline and Day 28
Outcome measures
| Measure |
Choline Bitartrate Tablets
n=20 Participants
Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
|
Whole Hardboiled Eggs
n=18 Participants
Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Hardboiled Eggs + Choline Bitartrate Tablets
n=16 Participants
Subjects will consume both four (4) whole, pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Pre-cooked, pre-peeled whole hardboiled eggs: Obtained from a commercial source.
|
Egg Whites + Choline Bitartrate Tablets
n=18 Participants
Subjects will consume both the egg whites (no yolks) of four (4) pre-cooked, pre-peeled hardboiled eggs and two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets
Egg whites from pre-cooked, pre-peeled hardboiled eggs: Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
|
Phosphatidylcholine Capsules
n=10 Participants
Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.
Phosphatidylcholine capsules: 420 mg phosphatidylcholine capsules obtained from a commercial source.
|
|---|---|---|---|---|---|
|
Changes in Lipid Profile, Triglycerides
Day 28
|
96 mg/dL
Interval 82.0 to 141.0
|
100 mg/dL
Interval 57.0 to 116.0
|
97 mg/dL
Interval 80.0 to 111.0
|
109 mg/dL
Interval 69.0 to 170.0
|
84 mg/dL
Interval 67.0 to 96.0
|
|
Changes in Lipid Profile, Triglycerides
Baseline
|
106 mg/dL
Interval 74.0 to 134.0
|
86 mg/dL
Interval 70.0 to 112.0
|
103 mg/dL
Interval 89.0 to 125.0
|
122 mg/dL
Interval 52.0 to 156.0
|
74 mg/dL
Interval 67.0 to 89.0
|
Adverse Events
Whole Hardboiled Eggs
Choline Bitartrate Tablets
Hardboiled Eggs + Choline Bitartrate Tablets
Egg Whites + Choline Bitartrate Tablets
Phosphatidylcholine Capsules
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