Status:
COMPLETED
PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eggland's Best
Conditions:
Hypercholesterolemia
Hyperlipidemia
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 m...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04673721
Start Date
January 6 2021
End Date
December 13 2022
Last Update
January 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Health System
Durham, North Carolina, United States, 27710