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

NCT04673721 | Completed DMC

• 1 other identifier: Pro00105996
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Hyperlipidemia; Vitamin Deficiency; Obesity

Keywords

Fortified eggs; High cholesterol

Outcome Measures

Primary Outcomes (2)

• Change in LDL-cholesterol

  Baseline, 4 months

• Change in HDL-cholesterol

  Baseline, 4 months

Secondary Outcomes (15)

• 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

Other Outcomes (4)

• Change in weight

  Baseline, 4 months

• Change in blood pressure

  Baseline, 4 months

• Change in Dietary intake (2005-Block Questionnaire)

  Baseline, 4 months

Study Arms (4)

Fortified eggs + Intermittent fasting

ACTIVE COMPARATOR

Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window.

Dietary Supplement: Fortified eggs; Behavioral: Intermittent fasting

Non-egg supplemented diet + Intermittent fasting

ACTIVE COMPARATOR

Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window.

Behavioral: Intermittent fasting; Dietary Supplement: Non-egg supplemented

Fortified eggs + Usual care diet

ACTIVE COMPARATOR

Consume at least 12 fortified eggs per week with consistency with current diet.

Dietary Supplement: Fortified eggs; Behavioral: Usual care diet

Non-egg supplemented diet + Usual care diet

PLACEBO COMPARATOR

Maintain consumption of 2 or less eggs per week with consistency with current diet.

Dietary Supplement: Non-egg supplemented; Behavioral: Usual care diet

Interventions

Fortified eggs DIETARY_SUPPLEMENT

Average 12 eggs consumed per week

Fortified eggs + Intermittent fasting; Fortified eggs + Usual care diet

Intermittent fasting BEHAVIORAL

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).

Fortified eggs + Intermittent fasting; Non-egg supplemented diet + Intermittent fasting

Non-egg supplemented DIETARY_SUPPLEMENT

2 or less eggs consumed per week

Non-egg supplemented diet + Intermittent fasting; Non-egg supplemented diet + Usual care diet

Usual care diet BEHAVIORAL

Consistency with current diet without consideration of intermittent fasting

Fortified eggs + Usual care diet; Non-egg supplemented diet + Usual care diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 50 years of age AND
• At least one of the following two criteria:
• Prior cardiovascular event (myocardial infarction, coronary revascularization or ischemic stroke) OR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Eggland's Best: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Nouhravesh N, Harrington J, Aberle LH, Green CL, Voss K, Holdsworth D, Misialek K, Slaugh BT, Wieand M, Yancy WS Jr, Pagidipati N, Mentz RJ. Effects of fortified eggs and time-restricted eating on cardiometabolic health: The prosperity trial. Am Heart J. 2025 Jan;279:27-39. doi: 10.1016/j.ahj.2024.10.005. Epub 2024 Oct 15.

  PMID: 39414223 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipidemias; Avitaminosis; Obesity

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Mentz, MD, FACC, FAHA, FHFSA

  Duke Cardiovascular Disease Fellowship

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: January 6, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)