Clinical Trials Directory

Trials / Completed

CompletedNCT03877003

Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.

Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
University of Connecticut · Academic / Other
Sex
All
Age
35 Years – 70 Years
Healthy volunteers
Accepted

Summary

The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.

Detailed description

Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome. Therefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.

Conditions

Interventions

TypeNameDescription
OTHEREggsEggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks

Timeline

Start date
2018-11-01
Primary completion
2019-12-14
Completion
2020-06-30
First posted
2019-03-15
Last updated
2020-11-03

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03877003. Inclusion in this directory is not an endorsement.