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Assessment of TMAO Formation With Egg Intake Versus Choline Supplement in a Healthy Population

University of Connecticut logo

University of Connecticut

Status

Completed

Conditions

Cardiovascular Risk Factor

Treatments

Dietary Supplement: Choline Supplement
Other: Eggs

Study type

Interventional

Funder types

Other

Identifiers

NCT03142763
H16-194

Details and patient eligibility

About

The objective of this study is to determine the effects of consuming either 3 eggs per day as compared to a daily choline supplement (choline bitartrate, 397.5 mg choline/day) on plasma concentrations of High Density Lipoprotein-cholesterol (HDL-C), trimethylamine N-oxide (TMAO), and other biomarkers of cardiovascular disease risk in young, healthy individuals. The goal is to determine if choline given as phosphatidylcholine (eggs) will lead to a different TMAO response when compared to choline in free supplemental form.

Full description

Epidemiological data in short term studies, suggests that egg intake does not increase risk for cardiovascular disease (CVD). In fact, eggs are a great source of phospholipids (phosphatidylcholine) where choline has many metabolic roles, specially in lipid metabolism and cell membrane structure. Choline is present in the diet as free choline, which is absorbed in the small intestines, or choline esters, which is absorbed intact primarily through the lymphatic system. In addition, recent evidence suggests that the choline found in eggs may be metabolized by intestinal microbes into trimethylamine N-oxide (TMAO), a compound that may increase the risk for CVD. However, it is not known to what extent egg intake may contribute to plasma TMAO concentrations.

Therefore, the objective of this study is to determine the impacts of daily intake of 3 eggs versus a choline supplement on plasma TMAO as well as other biomarkers for CVD risk, with the goal of determining if the same amount of choline given as phosphatidylcholine from eggs will increase plasma choline levels without a concomitant increase in plasma TMAO, such that CVD risk is not negatively impacted.

Enrollment

30 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Men and women (18-30 years), BMI 18.5 - 29.9 kg/m2, proficient in English, and willing to consume 3 eggs per day or 397.5 mg of choline supplement (1½ tablets/day) for 4 weeks each.

Exclusion criteria

  • Self-reported diabetes mellitus, cardiovascular disease, history of stroke, renal problems, liver disease, cancer, or a diagnosed eating disorder
  • Taking any glucose-lowering prescriptions or supplements, triglyceride-lowering medications, bile acid sequestrants, or high dose chromium or cinnamon supplements
  • Taken antibiotics in the previous 1 months, or if they are vegetarian or vegan
  • BMI ≤ 18.4 or ≥ 30 kg/m2, or extreme clinical values, such as plasma triglycerides > 500 mg/dL, plasma glucose > 126 mg/dL, plasma cholesterol > 240 mg/dL, plasma creatinine ≤ 0.5 or ≥ 0.9 mg/dL for females and ≤ 0.7 or ≥ 1.2 mg/dL for males, or blood pressure > 140/90 mm Hg (average of 3 readings)
  • Allergic to eggs or any component of the choline supplement

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Egg intake
Experimental group
Description:
Consumption of 3 eggs per day for breakfast, 4 weeks
Treatment:
Other: Eggs
Choline Supplement intake
Experimental group
Description:
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
Treatment:
Dietary Supplement: Choline Supplement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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