Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)
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ClinicalTrials.gov Identifier: NCT03039023 |
Recruitment Status :
Completed
First Posted : February 1, 2017
Results First Posted : May 14, 2021
Last Update Posted : June 2, 2021
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Study Type | Interventional |
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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 |
---|---|---|---|---|---|
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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 | |
---|---|---|---|---|---|---|---|
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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 | |
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[Not Specified]
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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)
|
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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%
|
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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)
|
Name/Title: | Jennifer Wilcox |
Organization: | Cleveland Clinic Foundation |
Phone: | 216-636-6153 |
EMail: | kirsopj@ccf.org |
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 |