PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

Inclusion criteria

• ≥ 50 years of age AND
• At least one of the following two criteria:

• Prior cardiovascular event (myocardial infarction, coronary revascularization or ischemic stroke) OR
• 2 cardiovascular risk factors including: 1) Diabetes mellitus (Defined as taking a medication for diabetes OR HgbA1c ≥6.5% within the prior 18 months; patients with diabetes may be treated with medications that are not associated with hypoglycemia such as metformin, thiazolidinediones (TZDs), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium glucose co-transporter 2 (SGLT2) inhibitors and/or dipeptidyl peptidase-4 (DPP-4) inhibitors, 2) Body mass index (BMI) ≥ 30 kg/m2, 3) Hypertension (Defined as taking blood pressure lowering medications OR systolic BP > 140mmHg at screening OR diastolic BP > 90mmHg at screening), 4) Dyslipidemia (Defined as taking lipid lowering medication OR LDL ≥130 OR HDL <50 for women OR HDL <40 for men OR triglycerides ≥150), or 5) Chronic kidney disease (Defined as eGFR <60 on most recent laboratory assessment within prior 18 months)
• Signed informed consent

Exclusion criteria

• Known allergy or intolerance to eggs
• Patients with diabetes who are on insulin or insulin secretagogues (e.g., sulfonylureas and meglitinides)
• Recent cardiovascular event (MI, stroke, HF hospitalization) within the past 30 days
• Planned initiation/change in lipid therapy within the next 4 months
• Current daily use of any supplements or multivitamins containing Vitamin B2 (riboflavin), Vitamin B12, Vitamin D, Vitamin E, or selenium or planned initiation within the next 4 months (current users need a 1-month washout period off supplement prior to eligibility)
• Inability or unwillingness to comply with the study requirements
• History of heart transplant or left ventricular assist device
• Pregnant or nursing women
• Malignancy or other non-cardiac condition limiting life expectancy to <4 months
• Consumption of > 2 eggs per week (this does not include eggs contained within other foods)
• Ongoing or recent (prior 30 days) participation in another interventional study