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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2022-12-13

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.

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Detailed Description

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Conditions

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Hypercholesterolemia Hyperlipidemia Vitamin Deficiency Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fortified eggs + Intermittent fasting

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

Group Type ACTIVE_COMPARATOR

Fortified eggs

Intervention Type DIETARY_SUPPLEMENT

Average 12 eggs consumed per week

Intermittent fasting

Intervention Type 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).

Non-egg supplemented diet + Intermittent fasting

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

Group Type ACTIVE_COMPARATOR

Intermittent fasting

Intervention Type 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).

Non-egg supplemented

Intervention Type DIETARY_SUPPLEMENT

2 or less eggs consumed per week

Fortified eggs + Usual care diet

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

Group Type ACTIVE_COMPARATOR

Fortified eggs

Intervention Type DIETARY_SUPPLEMENT

Average 12 eggs consumed per week

Usual care diet

Intervention Type BEHAVIORAL

Consistency with current diet without consideration of intermittent fasting

Non-egg supplemented diet + Usual care diet

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

Group Type PLACEBO_COMPARATOR

Non-egg supplemented

Intervention Type DIETARY_SUPPLEMENT

2 or less eggs consumed per week

Usual care diet

Intervention Type BEHAVIORAL

Consistency with current diet without consideration of intermittent fasting

Interventions

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Fortified eggs

Average 12 eggs consumed per week

Intervention Type DIETARY_SUPPLEMENT

Intermittent fasting

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).

Intervention Type BEHAVIORAL

Non-egg supplemented

2 or less eggs consumed per week

Intervention Type DIETARY_SUPPLEMENT

Usual care diet

Consistency with current diet without consideration of intermittent fasting

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No