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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

Baseline, 28 days

Results posted on

2025-11-04

Participant Flow

Participant milestones

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

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

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 days

Population: 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

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 28

The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.

Outcome measures

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 28

Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.

Outcome measures

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 28

Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.

Outcome measures

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 28

Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.

Outcome measures

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 28

Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.

Outcome measures

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 28

Changes in total cholesterol levels between baseline and Day 28

Outcome measures

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 28

Changes in measured HDL levels between baseline and Day 28

Outcome measures

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 28

Changes in measured LDL levels between baseline and Day 28

Outcome measures

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 28

Changes in measured triglyceride levels between baseline and Day 28

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Choline Bitartrate Tablets

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hardboiled Eggs + Choline Bitartrate Tablets

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Egg Whites + Choline Bitartrate Tablets

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Phosphatidylcholine Capsules

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

Jennifer Wilcox

Cleveland Clinic Foundation

Phone: 216-636-6153

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place