Clinical trial NCT04673721: PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health
Official title: PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hyperlipidemia
Vitamin Deficiency
Obesity
Keywords: Fortified eggs
High cholesterol
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eggland's Best
First posted: 2020-12-17
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in LDL-cholesterol
timeFrame: Baseline, 4 months
measure: Change in HDL-cholesterol
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Change in total cholesterol
timeFrame: Baseline, 4 months
measure: Change in triglycerides
timeFrame: Baseline, 4 months
measure: Change in NMP LipoProfile
timeFrame: Baseline, 4 months
measure: Change in lipoprotein subfractionation
timeFrame: Baseline, 4 months
measure: Change in apolipoprotein B
timeFrame: Baseline, 4 months
measure: Change in fatty acid profile
timeFrame: Baseline, 4 months
measure: Change in Vitamin B2 level
timeFrame: Baseline, 4 months
measure: Change in Vitamin B12 level
timeFrame: Baseline, 4 months
measure: Change in Vitamin D level
timeFrame: Baseline, 4 months
measure: Change in Vitamin E level
timeFrame: Baseline, 4 months
measure: Change in selenium level
timeFrame: Baseline, 4 months
measure: Change in high-sensitivity troponin (hsTroponin)
timeFrame: Baseline, 4 months
measure: Change in high-sensitivity c-reactive protein (hsCRP)
timeFrame: Baseline, 4 months
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline, 4 months
measure: Change in insulin resistance score (LP-IR)
timeFrame: Baseline, 4 months
Other outcomes:
measure: Change in weight
timeFrame: Baseline, 4 months
measure: Change in blood pressure
timeFrame: Baseline, 4 months
measure: Change in Dietary intake (2005-Block Questionnaire)
timeFrame: Baseline, 4 months
measure: Change in microbiome profile
timeFrame: Baseline through 4 months
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Cardiovascular Disease Fellowship
name: Robert Mentz, MD, FACC, FAHA, FHFSA
role: PRINCIPAL_INVESTIGATOR
References: