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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Hypercholesterolemia; Hyperlipidemia; Vitamin Deficiency
• Intervention / Treatment: Dietary supplement: Fortified eggs; Behavioral: Intermittent fasting; Dietary supplement: Non-egg supplemented; Behavioral: Usual care diet

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fortified eggs + Intermittent fasting; Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window.	Dietary supplement: Fortified eggs; Average 12 eggs consumed per week; Behavioral: Intermittent fasting; 16-hour fast and then an 8-hour nutritional window with aim for energy needs to be consumed during an 8 hour eating window (e.g., 11 am - 7 pm) with fasting for 16 hours (e.g., 7 pm - 11 am the next day).
Active Comparator: Non-egg supplemented diet + Intermittent fasting; Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window.	Behavioral: Intermittent fasting; 16-hour fast and then an 8-hour nutritional window with aim for energy needs to be consumed during an 8 hour eating window (e.g., 11 am - 7 pm) with fasting for 16 hours (e.g., 7 pm - 11 am the next day).; Dietary supplement: Non-egg supplemented; 2 or less eggs consumed per week
Active Comparator: Fortified eggs + Usual care diet; Consume at least 12 fortified eggs per week with consistency with current diet.	Dietary supplement: Fortified eggs; Average 12 eggs consumed per week; Behavioral: Usual care diet; Consistency with current diet without consideration of intermittent fasting
Placebo Comparator: Non-egg supplemented diet + Usual care diet; Maintain consumption of 2 or less eggs per week with consistency with current diet.	Dietary supplement: Non-egg supplemented; 2 or less eggs consumed per week; Behavioral: Usual care diet; Consistency with current diet without consideration of intermittent fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LDL-cholesterol	Baseline, 4 months
Change in HDL-cholesterol	Baseline, 4 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight		Baseline, 4 months
Change in blood pressure	Both systolic and diastolic blood pressure will be assessed	Baseline, 4 months
Change in Dietary intake (2005-Block Questionnaire)		Baseline, 4 months
Change in microbiome profile		Baseline through 4 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eggland's Best
• Investigators: Principal Investigator: Robert Mentz, MD, FACC, FAHA, FHFSA, Duke Cardiovascular Disease Fellowship

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: High cholesterol; Fortified eggs
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Deficiency Diseases; Malnutrition; Lipid Metabolism Disorders; Dyslipidemias; Hypercholesterolemia; Hyperlipidemias; Avitaminosis
• Other Study ID Numbers: Pro00105996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No