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Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039023
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : May 14, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Cardiovascular Risk Factor
Interventions Dietary Supplement: Choline Bitartrate
Other: Pre-cooked, pre-peeled whole hardboiled eggs
Other: Egg whites from pre-cooked, pre-peeled hardboiled eggs
Dietary Supplement: Phosphatidylcholine capsules
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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.

Period Title: Overall Study
Started 19 20 17 20 10
Completed 18 20 16 18 10
Not Completed 1 0 1 2 0
Reason Not Completed
Withdrawal by Subject             1             0             1             1             0
Physician Decision             0             0             0             1             0
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules Total
Hide Arm/Group Description

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 18 20 16 18 10 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 20 participants 16 participants 18 participants 10 participants 82 participants
25.5
(23.3 to 28.8)
27.0
(23.0 to 37.0)
37.0
(24.0 to 50.3)
30.0
(25.0 to 35.8)
31.5
(25.8 to 47.3)
28.0
(24.0 to 38.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 16 participants 18 participants 10 participants 82 participants
Female
8
  44.4%
9
  45.0%
15
  93.8%
10
  55.6%
6
  60.0%
48
  58.5%
Male
10
  55.6%
11
  55.0%
1
   6.3%
8
  44.4%
4
  40.0%
34
  41.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 20 participants 16 participants 18 participants 10 participants 82 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  16.7%
1
   5.0%
0
   0.0%
0
   0.0%
2
  20.0%
6
   7.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.1%
2
  10.0%
0
   0.0%
2
  11.1%
1
  10.0%
7
   8.5%
White
13
  72.2%
15
  75.0%
16
 100.0%
16
  88.9%
7
  70.0%
67
  81.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 20 participants 16 participants 18 participants 10 participants 82 participants
18
 100.0%
20
 100.0%
16
 100.0%
18
 100.0%
10
 100.0%
82
 100.0%
TMAO at Baseline  
Median (Inter-Quartile Range)
Unit of measure:  uM
Number Analyzed 18 participants 20 participants 16 participants 18 participants 10 participants 82 participants
2.0
(1.4 to 3.5)
1.9
(1.4 to 3.4)
2.3
(1.5 to 2.8)
2.6
(1.8 to 5.3)
2.8
(2.0 to 5.1)
2.3
(1.5 to 3.5)
1.Primary Outcome
Title Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
Hide Description Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with TMAO measured at baseline and Day 28.
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: uM
Baseline
2.0
(1.4 to 3.5)
1.9
(1.4 to 3.4)
2.3
(1.5 to 2.8)
2.6
(1.8 to 5.3)
2.8
(2.0 to 5.1)
Day 28
2.3
(1.9 to 3.7)
11.1
(7.1 to 25.4)
12.3
(5.1 to 26.5)
28.1
(9.2 to 44.1)
3.4
(2.6 to 7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.20
Comments A p-value <0.05 was considered significant.
Method Wilcoxon signed-rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.27
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
2.Primary Outcome
Title Changes in Platelet Function With Increased Choline Intake
Hide Description The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 10 10 10 9 10
Median (Inter-Quartile Range)
Unit of Measure: aggregation percentage
Baseline
2.6
(1.4 to 5.3)
2.6
(1.2 to 7.2)
2.3
(1.6 to 3.0)
3.0
(2.3 to 5.0)
2.8
(2.0 to 4.0)
Day 28
3.6
(2.5 to 7.7)
12.8
(7.6 to 27.2)
12.3
(6.1 to 25.7)
29.4
(17.9 to 43.3)
3.4
(2.6 to 7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.10
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.0002
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.01
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.006
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.79
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections
Hide Description Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 19 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: mg in 24 hours
Baseline
24.3
(13.0 to 44.3)
26.2
(15.6 to 40.3)
27.5
(9.1 to 36.2)
29.3
(18.4 to 45.9)
15.8
(12.9 to 35.6)
Day 28
28.5
(23.1 to 36.7)
139.0
(90.1 to 308.9)
221.8
(166.3 to 294.3)
186.9
(91.2 to 232.4)
33.1
(19.9 to 64.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.28
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.11
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
4.Secondary Outcome
Title Changes in Plasma Levels of Fasting Choline
Hide Description Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: uM
Baseline
8.3
(6.6 to 10.2)
7.5
(6.5 to 9.3)
8.5
(7.6 to 11.2)
9.5
(7.6 to 11.6)
7.6
(6.7 to 9.1)
Day 28
10.9
(8.9 to 12.4)
12.9
(10.8 to 16.0)
14.0
(11.7 to 15.7)
12.8
(10.2 to 14.1)
10.6
(9.2 to 11.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.005
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.009
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.04
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Plasma Levels of Fasting Carnitine.
Hide Description Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: uM
Baseline
19.1
(16.3 to 22.8)
21.2
(16.6 to 25.1)
21.5
(16.8 to 24.8)
21.1
(16.5 to 26.6)
23.4
(17.8 to 28.1)
Day 28
19.4
(13.4 to 27.9)
18.7
(15.5 to 21.0)
15.6
(10.9 to 19.4)
18.9
(15.2 to 23.2)
20.8
(19.1 to 27.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.93
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.01
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.003
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.04
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.99
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
6.Secondary Outcome
Title Changes in Plasma Levels of Fasting Betaine.
Hide Description Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: uM
Baseline
28.1
(23.6 to 48.3)
38.2
(28.7 to 48.7)
30.7
(18.4 to 35.7)
38.7
(23.3 to 47.7)
33.6
(23.3 to 45.0)
Day 28
39.7
(29.4 to 55.5)
69.0
(54.4 to 82.2)
46.9
(33.9 to 67.5)
59.8
(41.6 to 65.6)
46.3
(28.3 to 64.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Hardboiled Eggs
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.02
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Hardboiled Eggs + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value <0.0001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Egg Whites + Choline Bitartrate Tablets
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.001
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Phosphatidylcholine Capsules
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments For equivalence testing, the difference was assumed to be 0.
Statistical Test of Hypothesis P-Value 0.02
Comments A p-value <0.05 was considered significant.
Method Wilcoxon Signed Rank test
Comments [Not Specified]
7.Secondary Outcome
Title Changes in Lipid Profile, Total Cholesterol
Hide Description Changes in total cholesterol levels between baseline and Day 28
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
156
(145 to 175)
180
(147 to 201)
187
(172 to 204)
186
(150 to 189)
175
(159 to 217)
Day 28
158
(136 to 180)
172
(157 to 191)
198
(168 to 221)
178
(157 to 193)
172
(151 to 213)
8.Secondary Outcome
Title Changes in Lipid Profile, HDL
Hide Description Changes in measured HDL levels between baseline and Day 28
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
48
(44 to 66)
49
(40 to 60)
57
(50 to 65)
48
(39 to 63)
61
(49 to 65)
Day 28
49
(44 to 65)
51
(44 to 60)
56
(49 to 74)
50
(41 to 57)
62
(42 to 64)
9.Secondary Outcome
Title Changes in Lipid Profile, LDL
Hide Description Changes in measured LDL levels between baseline and Day 28
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
91
(72 to 102)
90
(80 to 124)
108
(98 to 120)
104
(86 to 124)
107
(90 to 137)
Day 28
86
(71 to 110)
94
(82 to 119)
118
(87 to 132)
101
(87 to 121)
106
(79 to 136)
10.Secondary Outcome
Title Changes in Lipid Profile, Triglycerides
Hide Description Changes in measured triglyceride levels between baseline and Day 28
Time Frame Baseline, Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description:

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

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 Number of Participants Analyzed 18 20 16 18 10
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
Baseline
86
(70 to 112)
106
(74 to 134)
103
(89 to 125)
122
(52 to 156)
74
(67 to 89)
Day 28
100
(57 to 116)
96
(82 to 141)
97
(80 to 111)
109
(69 to 170)
84
(67 to 96)
Time Frame Adverse event data were collected during study participation, up to 30 days from enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Hide Arm/Group Description

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.

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Choline Bitartrate: 500mg 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.

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.

Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.

420 mg phosphatidylcholine capsules obtained from a commercial source.

All-Cause Mortality
Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/20 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/20 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Whole Hardboiled Eggs Choline Bitartrate Tablets Hardboiled Eggs + Choline Bitartrate Tablets Egg Whites + Choline Bitartrate Tablets Phosphatidylcholine Capsules
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/17 (0.00%)   0/20 (0.00%)   0/10 (0.00%) 
Small sample sizes within each group created uneven distributions of some baseline characteristics; participants' dietary intake beyond the assigned interventions was not controlled during the study period; using only healthy controls makes the translatability of the results to other patient populations, like those with impaired renal function, unclear.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Wilcox
Organization: Cleveland Clinic Foundation
Phone: 216-636-6153
EMail: kirsopj@ccf.org
Layout table for additonal information
Responsible Party: Wilson Tang, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03039023    
Other Study ID Numbers: 16-1048
First Submitted: January 19, 2017
First Posted: February 1, 2017
Results First Submitted: April 21, 2021
Results First Posted: May 14, 2021
Last Update Posted: June 2, 2021