Cardiovascular Risk Factor
Conditions
Keywords
TMAO, choline, eggs, gastrointestinal microbiome, healthy volunteers
Brief summary
The investigators are interested in learning more about choline, a nutrient required by the body. The body does make some choline, but it does not make enough to support health and the rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary source of choline. Choline can also be given as a dietary supplement. Ingestion of choline supplements has been linked to an increased concentration of a compound called TMAO (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk. With this study, the investigators hope to learn whether there is a difference in the way your body responds to the ingestion of a choline supplement versus the choline found within eggs.
Detailed description
The principal goal for the study is to examine whether there is a difference between the ingestion of choline through supplements versus choline found within eggs on plasma TMAO levels. The investigators have previously shown that dietary intake of trimethylamines, including the choline group of phosphatidylcholine (PC), is mechanistically linked to cardiovascular disease risk and that the metabolism of these trimethylamine nutrients in humans is modulated by the intestinal microbes (gut microbes). Additionally, extensive animal studies link an essential role of gut microbiota to the metabolism of choline and the production of metabolites that promote / accelerate atherosclerotic processes. The investigators have also recently shown a 10-fold increase in plasma TMAO levels following supplementation with choline bitartrate supplements. However, another pilot study by a collaborator (unpublished) did not show the same increase in plasma TMAO levels following the ingestion of whole eggs, a major dietary source of choline. Therefore, with this study the investigators wish to examine the differences, if any, between the ingestion of an equivalent mass of total choline in the free form (as bitartrate salt) as a supplement vs. within whole eggs. Eggs, and specifically the egg yolk, contain a large amount of total choline. However, egg white contains potential anti-microbial peptides that could influence gut microbial composition and function, and therefore impact conversion of choline into TMA and TMAO observed in subjects. Therefore, the investigators hypothesize that the consumption of whole eggs (hardboiled) will not elevate plasma TMAO levels to the same extent as a comparable amount of total choline ingested in capsule form as the choline bitartrate salt. The investigators further hypothesize that the consumption of egg white with choline bitartrate tablets may result in less of a rise in TMAO levels than ingestion of the choline bitartrate supplement alone.
Interventions
DIETARY_SUPPLEMENTCholine Bitartrate
500mg choline bitartrate tablets
OTHERPre-cooked, pre-peeled whole hardboiled eggs
Obtained from a commercial source.
OTHEREgg whites from pre-cooked, pre-peeled hardboiled eggs
Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
DIETARY_SUPPLEMENTPhosphatidylcholine capsules
420 mg phosphatidylcholine capsules obtained from a commercial source.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men and women age 18 years or above. * Willing to remain on aspirin or stay off aspirin or aspirin products for 1 week prior to starting the study and throughout the study period. * Able to provide informed consent and comply with study protocol. * Able to be off all other supplements during the study period.
Exclusion criteria
* Significant chronic illness. * Active infection or received antibiotics within 1 month of study enrollment. * Use of over-the-counter probiotic within the past month * Chronic gastrointestinal disorders, such as ulcerative colitis or Crohn's disease. * Allergy to eggs or lactose. * Having undergone bariatric procedures or surgeries such as gastric banding or bypass. * Pregnancy. * Any condition that, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial or cause inability to comply with the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline, 28 days | Changes in levels of non-labeled TMAO from baseline to end-of-study (day 28) as measured by established techniques by mass spectrometry. |
| Changes in Platelet Function With Increased Choline Intake | Baseline, Day 28 | The activation and functioning of platelets within a single subject will be compared before and after increased choline intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Plasma Levels of Fasting Carnitine. | Baseline, Day 28 | Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared. |
| Changes in Plasma Levels of Fasting Betaine. | Baseline, Day 28 | Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared. |
| Changes in Lipid Profile, Total Cholesterol | Baseline, Day 28 | Changes in total cholesterol levels between baseline and Day 28 |
| Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline, Day 28 | Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques. |
| Changes in Lipid Profile, LDL | Baseline, Day 28 | Changes in measured LDL levels between baseline and Day 28 |
| Changes in Lipid Profile, Triglycerides | Baseline, Day 28 | Changes in measured triglyceride levels between baseline and Day 28 |
| Changes in Lipid Profile, HDL | Baseline, Day 28 | Changes in measured HDL levels between baseline and Day 28 |
| Changes in Plasma Levels of Fasting Choline | Baseline, Day 28 | Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| Choline Bitartrate Tablets Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.
Choline Bitartrate: 500mg choline bitartrate tablets | 20 |
| 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. | 16 |
| 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. | 18 |
| 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. | 10 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Whole Hardboiled Eggs | Choline Bitartrate Tablets | Hardboiled Eggs + Choline Bitartrate Tablets | Egg Whites + Choline Bitartrate Tablets | Phosphatidylcholine Capsules | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 25.5 years | 27.0 years | 37.0 years | 30.0 years | 31.5 years | 28.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 13 Participants | 15 Participants | 16 Participants | 16 Participants | 7 Participants | 67 Participants |
| Region of Enrollment United States | 18 Participants | 20 Participants | 16 Participants | 18 Participants | 10 Participants | 82 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 15 Participants | 10 Participants | 6 Participants | 48 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 1 Participants | 8 Participants | 4 Participants | 34 Participants |
| TMAO at Baseline | 2.0 uM | 1.9 uM | 2.3 uM | 2.6 uM | 2.8 uM | 2.3 uM |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 | 0 / 17 | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 0 / 19 | 0 / 20 | 0 / 17 | 0 / 20 | 0 / 10 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 | 0 / 17 | 0 / 20 | 0 / 10 |
Outcome results
Primary
Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite
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
Population: All participants with TMAO measured at baseline and Day 28.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline | 2.0 uM |
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Day 28 | 2.3 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline | 1.9 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Day 28 | 11.1 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline | 2.3 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Day 28 | 12.3 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Day 28 | 28.1 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline | 2.6 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Baseline | 2.8 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite | Day 28 | 3.4 uM |
p-value: 0.2Wilcoxon signed-rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: 0.27Wilcoxon Signed Rank test
Primary
Changes in Platelet Function With Increased Choline Intake
The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Platelet Function With Increased Choline Intake | Baseline | 2.6 aggregation percentage |
| Whole Hardboiled Eggs | Changes in Platelet Function With Increased Choline Intake | Day 28 | 3.6 aggregation percentage |
| Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Baseline | 2.6 aggregation percentage |
| Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Day 28 | 12.8 aggregation percentage |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Baseline | 2.3 aggregation percentage |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Day 28 | 12.3 aggregation percentage |
| Egg Whites + Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Day 28 | 29.4 aggregation percentage |
| Egg Whites + Choline Bitartrate Tablets | Changes in Platelet Function With Increased Choline Intake | Baseline | 3.0 aggregation percentage |
| Phosphatidylcholine Capsules | Changes in Platelet Function With Increased Choline Intake | Baseline | 2.8 aggregation percentage |
| Phosphatidylcholine Capsules | Changes in Platelet Function With Increased Choline Intake | Day 28 | 3.4 aggregation percentage |
p-value: 0.1Wilcoxon Signed Rank test
p-value: 0.0002Wilcoxon Signed Rank test
p-value: 0.01Wilcoxon Signed Rank test
p-value: 0.006Wilcoxon Signed Rank test
p-value: 0.79Wilcoxon Signed Rank test
Secondary
Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections
Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline | 24.3 mg in 24 hours |
| Whole Hardboiled Eggs | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Day 28 | 28.5 mg in 24 hours |
| Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline | 26.2 mg in 24 hours |
| Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Day 28 | 139.0 mg in 24 hours |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline | 27.5 mg in 24 hours |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Day 28 | 221.8 mg in 24 hours |
| Egg Whites + Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Day 28 | 186.9 mg in 24 hours |
| Egg Whites + Choline Bitartrate Tablets | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline | 29.3 mg in 24 hours |
| Phosphatidylcholine Capsules | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Baseline | 15.8 mg in 24 hours |
| Phosphatidylcholine Capsules | Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections | Day 28 | 33.1 mg in 24 hours |
p-value: 0.28Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: 0.11Wilcoxon Signed Rank test
Secondary
Changes in Lipid Profile, HDL
Changes in measured HDL levels between baseline and Day 28
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Lipid Profile, HDL | Baseline | 48 mg/dL |
| Whole Hardboiled Eggs | Changes in Lipid Profile, HDL | Day 28 | 49 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Baseline | 49 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Day 28 | 51 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Baseline | 57 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Day 28 | 56 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Day 28 | 50 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, HDL | Baseline | 48 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, HDL | Baseline | 61 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, HDL | Day 28 | 62 mg/dL |
Secondary
Changes in Lipid Profile, LDL
Changes in measured LDL levels between baseline and Day 28
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Lipid Profile, LDL | Baseline | 91 mg/dL |
| Whole Hardboiled Eggs | Changes in Lipid Profile, LDL | Day 28 | 86 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Baseline | 90 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Day 28 | 94 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Baseline | 108 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Day 28 | 118 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Day 28 | 101 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, LDL | Baseline | 104 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, LDL | Baseline | 107 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, LDL | Day 28 | 106 mg/dL |
Secondary
Changes in Lipid Profile, Total Cholesterol
Changes in total cholesterol levels between baseline and Day 28
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Lipid Profile, Total Cholesterol | Baseline | 156 mg/dL |
| Whole Hardboiled Eggs | Changes in Lipid Profile, Total Cholesterol | Day 28 | 158 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Baseline | 180 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Day 28 | 172 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Baseline | 187 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Day 28 | 198 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Day 28 | 178 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, Total Cholesterol | Baseline | 186 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, Total Cholesterol | Baseline | 175 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, Total Cholesterol | Day 28 | 172 mg/dL |
Secondary
Changes in Lipid Profile, Triglycerides
Changes in measured triglyceride levels between baseline and Day 28
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Lipid Profile, Triglycerides | Baseline | 86 mg/dL |
| Whole Hardboiled Eggs | Changes in Lipid Profile, Triglycerides | Day 28 | 100 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Baseline | 106 mg/dL |
| Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Day 28 | 96 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Baseline | 103 mg/dL |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Day 28 | 97 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Day 28 | 109 mg/dL |
| Egg Whites + Choline Bitartrate Tablets | Changes in Lipid Profile, Triglycerides | Baseline | 122 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, Triglycerides | Baseline | 74 mg/dL |
| Phosphatidylcholine Capsules | Changes in Lipid Profile, Triglycerides | Day 28 | 84 mg/dL |
Secondary
Changes in Plasma Levels of Fasting Betaine.
Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Betaine. | Day 28 | 39.7 uM |
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Betaine. | Baseline | 28.1 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Baseline | 38.2 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Day 28 | 69.0 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Day 28 | 46.9 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Baseline | 30.7 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Baseline | 38.7 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Betaine. | Day 28 | 59.8 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Betaine. | Day 28 | 46.3 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Betaine. | Baseline | 33.6 uM |
p-value: 0.02Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: <0.0001Wilcoxon Signed Rank test
p-value: 0.001Wilcoxon Signed Rank test
p-value: 0.02Wilcoxon Signed Rank test
Secondary
Changes in Plasma Levels of Fasting Carnitine.
Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Carnitine. | Baseline | 19.1 uM |
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Carnitine. | Day 28 | 19.4 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Day 28 | 18.7 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Baseline | 21.2 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Day 28 | 15.6 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Baseline | 21.5 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Baseline | 21.1 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Carnitine. | Day 28 | 18.9 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Carnitine. | Day 28 | 20.8 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Carnitine. | Baseline | 23.4 uM |
p-value: 0.93Wilcoxon Signed Rank test
p-value: 0.01Wilcoxon Signed Rank test
p-value: 0.003Wilcoxon Signed Rank test
p-value: 0.04Wilcoxon Signed Rank test
p-value: 0.99Wilcoxon Signed Rank test
Secondary
Changes in Plasma Levels of Fasting Choline
Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Choline | Baseline | 8.3 uM |
| Whole Hardboiled Eggs | Changes in Plasma Levels of Fasting Choline | Day 28 | 10.9 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Baseline | 7.5 uM |
| Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Day 28 | 12.9 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Baseline | 8.5 uM |
| Hardboiled Eggs + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Day 28 | 14.0 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Day 28 | 12.8 uM |
| Egg Whites + Choline Bitartrate Tablets | Changes in Plasma Levels of Fasting Choline | Baseline | 9.5 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Choline | Baseline | 7.6 uM |
| Phosphatidylcholine Capsules | Changes in Plasma Levels of Fasting Choline | Day 28 | 10.6 uM |
p-value: 0.005Wilcoxon Signed Rank test
p-value: <0.001Wilcoxon Signed Rank test
p-value: <0.001Wilcoxon Signed Rank test
p-value: 0.009Wilcoxon Signed Rank test
p-value: 0.04Wilcoxon Signed Rank test