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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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