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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypercholesterolemia, Hyperlipidemia, Vitamin Deficiency, Obesity

Intervention / Treatment
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* Dietary Supplement: Fortified eggs
* Behavioral: Intermittent fasting
* Dietary Supplement: Non-egg supplemented
* Behavioral: Usual care diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fortified eggs + Intermittent fasting<br>Consume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window. | Dietary Supplement: Fortified eggs<br>* Average 12 eggs consumed per week<br>Behavioral: Intermittent fasting<br>* 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).<br>|
| Active Comparator: Non-egg supplemented diet + Intermittent fasting<br>Maintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window. | Behavioral: Intermittent fasting<br>* 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).<br>Dietary Supplement: Non-egg supplemented<br>* 2 or less eggs consumed per week<br>|
| Active Comparator: Fortified eggs + Usual care diet<br>Consume at least 12 fortified eggs per week with consistency with current diet. | Dietary Supplement: Fortified eggs<br>* Average 12 eggs consumed per week<br>Behavioral: Usual care diet<br>* Consistency with current diet without consideration of intermittent fasting<br>|
| Placebo Comparator: Non-egg supplemented diet + Usual care diet<br>Maintain consumption of 2 or less eggs per week with consistency with current diet. | Dietary Supplement: Non-egg supplemented<br>* 2 or less eggs consumed per week<br>Behavioral: Usual care diet<br>* Consistency with current diet without consideration of intermittent fasting<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fortified eggs, High cholesterol