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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor
• Interventions: Dietary Supplement: Choline Supplement; Other: Eggs

• Registration Number: NCT03142763
• Lead Sponsor: University of Connecticut

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-05
• Primary Completion: 2018-04-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Choline Supplement intake	Choline Supplement	Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
Egg intake	Eggs	Consumption of 3 eggs per day for breakfast, 4 weeks

Primary Outcome Measures

Name	Time	Method
Eggs of Egg Consumption on Plasma Biochemical Parameters	1 year	Using plasma form each participant, an automated spectrophotometer is able to analyze at once plasma lipids \[total colesterol, triglycerides, HDL (mg/dL)\], glucose (mg/dL), CRP (mg/dL, and liver enzymes \[alanine aminotransferase and aspartate aminotransferase (U/L)\].

Secondary Outcome Measures

Name	Time	Method
Effects of Intervention on Gene Expression using RT-PCR	1 year	PBMC will be isolated from whole blood. RNA will be isolated from these cells, and then cDNA will be synthesized using a specific kit. Finally a RT-PCR will be used to analyze the expression of genes, such as: GAPDH, HMG-CoA reductase, LDL-r, CD36, SRA, FMO3, SRB1, PPAR-gama. All results will be presented based on house keeping gene GAPDH.

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States