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OpenTrials
Completed

NCT Number: NCT03039023

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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 However, another pilot study by a collaborator (unpublished) did not show the same increase in plasma TMAO levels following the ingestion of whole eggs, a major dietary source of choline.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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Choline bitartrate

Dietary Supplement

500mg choline bitartrate tablets

Pre-cooked, pre-peeled whole hardboiled eggs

Other

Obtained from a commercial source.

Egg whites from pre-cooked, pre-peeled hardboiled eggs

Other

Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.

Phosphatidylcholine capsules

Dietary Supplement

420 mg phosphatidylcholine capsules obtained from a commercial source.

Primary outcomes

  1. Changes in Plasma Levels of Fasting Trimethylamine-N-oxide (TMAO), a Choline Metabolite

    Time frame: 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.

  2. Changes in Platelet Function With Increased Choline Intake

    Time frame: Baseline, Day 28

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

Secondary outcomes

  1. Changes in Levels of Fasting Trimethylamine-N-oxide (TMAO) in 24-hour Urine Collections

    Time frame: Baseline, Day 28

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

  2. Changes in Plasma Levels of Fasting Choline

    Time frame: Baseline, Day 28

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

  3. Changes in Plasma Levels of Fasting Carnitine.

    Time frame: Baseline, Day 28

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

  4. Changes in Plasma Levels of Fasting Betaine.

    Time frame: Baseline, Day 28

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

  5. Changes in Lipid Profile, Total Cholesterol

    Time frame: Baseline, Day 28

    Changes in total cholesterol levels between baseline and Day 28

  6. Changes in Lipid Profile, HDL

    Time frame: Baseline, Day 28

    Changes in measured HDL levels between baseline and Day 28

  7. Changes in Lipid Profile, LDL

    Time frame: Baseline, Day 28

    Changes in measured LDL levels between baseline and Day 28

  8. Changes in Lipid Profile, Triglycerides

    Time frame: Baseline, Day 28

    Changes in measured triglyceride levels between baseline and Day 28

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Acronym: EGGS

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Feb 1, 2017
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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