N/A
Completed N=86
Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans
Cardiovascular Risk Factor
Source: ClinicalTrials.gov NCT03039023 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite — 2.0; 1.9; 2.3; 2.6 uM — p=0.20
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite |
2.0; 1.9; 2.3; 2.6; 2.8; 2.3 | 0.20 |
| PRIMARY Changes in Platelet Function With Increased Choline Intake |
2.6; 2.6; 2.3; 3.0; 2.8; 3.6 | 0.10 |
| SECONDARY Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections |
24.3; 26.2; 27.5; 29.3; 15.8; 28.5 | 0.28 |
| SECONDARY Changes in Plasma Levels of Fasting Choline |
8.3; 7.5; 8.5; 9.5; 7.6; 10.9 | 0.005 sig |
| SECONDARY Changes in Plasma Levels of Fasting Carnitine. |
19.1; 21.2; 21.5; 21.1; 23.4; 19.4 | 0.93 |
| SECONDARY Changes in Plasma Levels of Fasting Betaine. |
28.1; 38.2; 30.7; 38.7; 33.6; 39.7 | 0.02 sig |
| SECONDARY Changes in Lipid Profile, Total Cholesterol |
156; 180; 187; 186; 175; 158 | — |
| SECONDARY Changes in Lipid Profile, HDL |
48; 49; 57; 48; 61; 49 | — |
| SECONDARY Changes in Lipid Profile, LDL |
91; 90; 108; 104; 107; 86 | — |
| SECONDARY Changes in Lipid Profile, Triglycerides |
86; 106; 103; 122; 74; 100 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03039023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.