Clinical trial NCT03877003: Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
Official title: Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes
Metabolic Syndrome
Keywords: eggs,
choline
metabolic syndrome
TMAO
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2019-03-15
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* All genders
* 35-70 years
* Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference \> 88 cm for women and \> 102 cm for men, plasma triglycerides \> 150 mg/dL, fasting glucose \> 100 mg/dL, blood pressure \> 135/85 and HDL \< 40 mg/dL for men and \< 50 mg/dL for women),
* willing to consume 3 eggs per day for 4 weeks
* willing to consume choline supplement (400 mg/day for 4 weeks)

Exclusion Criteria:

* Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer
* Taking glucose lowering medications
* Taking antibiotics in the previous 1 month
* Triglycerides \> 500 mg/dL,
* Cholesterol \> 240 mg/dL,
* blood pressure \> 145/100 mm of Hg
* Allergic to eggs or to choline

Primary outcomes:
measure: Plasma choline and TMAO (micromol/L)
timeFrame: 1 year
measure: Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL
timeFrame: 1 year
Secondary outcomes:
measure: Analysis of microbiota diversity (expressed as concentrations of different microorganisms.
timeFrame: 1 year
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Department of Nutritional Sciences
state: Connecticut
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References: