Cardiovascular Risk Factor
Conditions
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.
Interventions
OTHEREggs
Consumption of 3 eggs per day for breakfast, 4 weeks
DIETARY_SUPPLEMENTCholine Supplement
Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
Sponsors
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed