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

Not Applicable

Completed

Interventions: Behavioral: Intermittent fasting
Dietary Supplement: Fortified eggs
Dietary Supplement: Non-egg supplemented
Behavioral: Usual care diet

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 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (\~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Non-egg supplemented diet + Intermittent fasting	Intermittent fasting	Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window.
Non-egg supplemented diet + Intermittent fasting	Non-egg supplemented	Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window.
Fortified eggs + Usual care diet	Usual care diet	Consume at least 12 fortified eggs per week with consistency with current diet.
Non-egg supplemented diet + Usual care diet	Non-egg supplemented	Maintain consumption of 2 or less eggs per week with consistency with current diet.
Fortified eggs + Intermittent fasting	Intermittent fasting	Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window.
Fortified eggs + Usual care diet	Fortified eggs	Consume at least 12 fortified eggs per week with consistency with current diet.
Fortified eggs + Intermittent fasting	Fortified eggs	Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window.
Non-egg supplemented diet + Usual care diet	Usual care diet	Maintain consumption of 2 or less eggs per week with consistency with current diet.

Primary Outcome Measures

Name	Time	Method
Change in LDL-cholesterol	Baseline, 4 months
Change in HDL-cholesterol	Baseline, 4 months

Secondary Outcome Measures

Name	Time	Method
Change in total cholesterol	Baseline, 4 months
Change in Vitamin E level	Baseline, 4 months
Change in high-sensitivity troponin (hsTroponin)	Baseline, 4 months
Change in Vitamin D level	Baseline, 4 months
Change in triglycerides	Baseline, 4 months
Change in lipoprotein subfractionation	Baseline, 4 months
Change in selenium level	Baseline, 4 months
Change in hemoglobin A1c (HbA1c)	Baseline, 4 months
Change in insulin resistance score (LP-IR)	Baseline, 4 months
Change in apolipoprotein B	Baseline, 4 months
Change in fatty acid profile	Baseline, 4 months
Change in high-sensitivity c-reactive protein (hsCRP)	Baseline, 4 months
Change in NMP LipoProfile	Baseline, 4 months
Change in Vitamin B2 level	Baseline, 4 months
Change in Vitamin B12 level	Baseline, 4 months

Locations (1): Duke University Health System
🇺🇸
Durham, North Carolina, United States