Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | September 2, 2016 |
| End Date: | December 2018 |
Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)
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.
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.
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.
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.
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.
We found this trial at
1
site
2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: W. H. Wilson Tang, MD
Phone: 216-636-6153
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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