Coronary Artery Disease, Diabetes, Metabolic Syndrome
Conditions
Keywords
eggs,, choline, metabolic syndrome, TMAO
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.
Interventions
OTHEREggs
Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
Sponsors
American Egg Board
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized crossover design
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma choline and TMAO (micromol/L) | 1 year | They will be measured simultaneously by use of a mass spectrophotometer |
| Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL | 1 year | They will be measured simultaneoulsy by use of an automated spectrophotometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of microbiota diversity (expressed as concentrations of different microorganisms. | 1 year | All microorganisms are assayed simultaneously |
Countries
United States
Outcome results
None listed