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

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Hyperlipidemia; Vitamin Deficiency; Obesity

• Registration Number: NCT04673721
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-16
• Study First Posted: 2020-12-17
• Study Start: 2021-01-06
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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 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
Change in total cholesterol	Baseline, 4 months

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States