Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT03039023
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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 However, another pilot study by a collaborator (unpublished) did not show the same increase in plasma TMAO levels following the ingestion of whole eggs, a major dietary source of choline.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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
500mg choline bitartrate tablets
Obtained from a commercial source.
Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
420 mg phosphatidylcholine capsules obtained from a commercial source.
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.
Time frame: Baseline, Day 28
The activation and functioning of platelets within a single subject will be compared before and after increased choline intake.
Time frame: Baseline, Day 28
Changes in levels of non-labeled TMAO from baseline to Day 28 measured by established mass spectrometry techniques.
Time frame: Baseline, Day 28
Fasting plasma levels of choline from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
Fasting plasma levels of carnitine from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
Fasting plasma levels of betaine from samples obtained at baseline and at day 28 were compared.
Time frame: Baseline, Day 28
Changes in total cholesterol levels between baseline and Day 28
Time frame: Baseline, Day 28
Changes in measured HDL levels between baseline and Day 28
Time frame: Baseline, Day 28
Changes in measured LDL levels between baseline and Day 28
Time frame: Baseline, Day 28
Changes in measured triglyceride levels between baseline and Day 28
The Cleveland Clinic
Other
Effects of Choline From Eggs vs. Supplements on the Generation of TMAO in Humans (EGGS)
Acronym: EGGS
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