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

Duke University

Status: Completed

Conditions: Hyperlipidemia; Hypercholesterolemia; Obesity; Vitamin Deficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04673721

Pro00105996

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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140 participants in 4 patient groups, including a placebo group

Fortified eggs + Intermittent fasting

Active Comparator group

Description:

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

Treatment:

Behavioral: Intermittent fasting

Dietary Supplement: Fortified eggs

Non-egg supplemented diet + Intermittent fasting

Active Comparator group

Description:

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

Treatment:

Behavioral: Intermittent fasting

Dietary Supplement: Non-egg supplemented

Fortified eggs + Usual care diet

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Fortified eggs

Behavioral: Usual care diet

Non-egg supplemented diet + Usual care diet

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Usual care diet

Dietary Supplement: Non-egg supplemented