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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142763
• Other study ID #: H16-194
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Other:
• Eggs
Consumption of 3 eggs per day for breakfast, 4 weeks

Dietary Supplement:
• Choline Supplement
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eggs of Egg Consumption on Plasma Biochemical Parameters	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)].	1 year
Secondary	Effects of Intervention on Gene Expression using RT-PCR	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.	1 year