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

NeuroTherapia, Inc.

Status

Completed

Conditions

Cardiovascular Risk Factor

Treatments

Dietary Supplement: Choline Bitartrate

Other: Pre-cooked, pre-peeled whole hardboiled eggs

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

Dietary Supplement: Phosphatidylcholine capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT03039023

16-1048

Details and patient eligibility

About

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.

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 However, another pilot study by a collaborator (unpublished) did not show the same increase in plasma TMAO levels following the ingestion of whole eggs, a major dietary source of choline.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

Enrollment

86 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 5 patient groups

Whole Hardboiled Eggs

Experimental group

Description:

Subjects will consume four (4) pre-cooked, pre-peeled whole hardboiled eggs per day for 28 days.

Treatment:

Other: Pre-cooked, pre-peeled whole hardboiled eggs

Choline Bitartrate Tablets

Experimental group

Description:

Subjects will consume two (2) 500mg choline bitartrate tablets per day for 28 days.

Treatment:

Dietary Supplement: Choline Bitartrate

Hardboiled Eggs + Choline Bitartrate Tablets

Experimental group

Description:

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.

Treatment:

Other: Pre-cooked, pre-peeled whole hardboiled eggs

Dietary Supplement: Choline Bitartrate

Egg Whites + Choline Bitartrate Tablets

Experimental group

Description:

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.

Treatment:

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

Dietary Supplement: Choline Bitartrate

Phosphatidylcholine Capsules

Experimental group

Description:

Subjects will consume six (6) 420 mg phosphatidylcholine capsules by mouth per day for 28 days.

Treatment:

Dietary Supplement: Phosphatidylcholine capsules

Trial documents