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

Primary Purpose

Hypercholesterolemia, Hyperlipidemia, Vitamin Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fortified eggs

Intermittent fasting

Non-egg supplemented

Usual care diet

About this trial

This is an interventional other trial for Hypercholesterolemia focused on measuring Fortified eggs, High cholesterol

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Duke University Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fortified eggs + Intermittent fasting

Non-egg supplemented diet + Intermittent fasting

Fortified eggs + Usual care diet

Non-egg supplemented diet + Usual care diet

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change in LDL-cholesterol

Change in HDL-cholesterol

Secondary Outcome Measures

Change in total cholesterol

Change in triglycerides

Change in NMP LipoProfile

Change in lipoprotein subfractionation

Change in apolipoprotein B

Change in fatty acid profile

Change in Vitamin B2 level

Change in Vitamin B12 level

Change in Vitamin D level

Change in Vitamin E level

Change in selenium level

Change in high-sensitivity troponin (hsTroponin)

Change in high-sensitivity c-reactive protein (hsCRP)

Change in hemoglobin A1c (HbA1c)

Change in insulin resistance score (LP-IR)

Full Information

NCT ID

NCT04673721

First Posted

December 9, 2020

Last Updated

January 20, 2023

Sponsor

Duke University

Collaborators

Eggland's Best

1. Study Identification

Unique Protocol Identification Number

NCT04673721

Brief Title

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

Acronym

PROSPERITY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 6, 2021 (Actual)

Primary Completion Date

December 13, 2022 (Actual)

Study Completion Date

December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Eggland's Best

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Hyperlipidemia, Vitamin Deficiency, Obesity

Keywords

Fortified eggs, High cholesterol

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fortified eggs + Intermittent fasting

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-egg supplemented diet + Intermittent fasting

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fortified eggs + Usual care diet

Arm Type

Active Comparator

Arm Description

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

Arm Title

Non-egg supplemented diet + Usual care diet

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortified eggs

Intervention Description

Average 12 eggs consumed per week

Intervention Type

Behavioral

Intervention Name(s)

Intermittent fasting

Intervention Description

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

Dietary Supplement

Intervention Name(s)

Non-egg supplemented

Intervention Description

2 or less eggs consumed per week

Intervention Type

Behavioral

Intervention Name(s)

Usual care diet

Intervention Description

Consistency with current diet without consideration of intermittent fasting

Primary Outcome Measure Information:

Title

Change in LDL-cholesterol

Time Frame

Baseline, 4 months

Title

Change in HDL-cholesterol

Time Frame

Baseline, 4 months

Secondary Outcome Measure Information:

Title

Change in total cholesterol

Time Frame

Baseline, 4 months

Title

Change in triglycerides

Time Frame

Baseline, 4 months

Title

Change in NMP LipoProfile

Time Frame

Baseline, 4 months

Title

Change in lipoprotein subfractionation

Time Frame

Baseline, 4 months

Title

Change in apolipoprotein B

Time Frame

Baseline, 4 months

Title

Change in fatty acid profile

Time Frame

Baseline, 4 months

Title

Change in Vitamin B2 level

Time Frame

Baseline, 4 months

Title

Change in Vitamin B12 level

Time Frame

Baseline, 4 months

Title

Change in Vitamin D level

Time Frame

Baseline, 4 months

Title

Change in Vitamin E level

Time Frame

Baseline, 4 months

Title

Change in selenium level

Time Frame

Baseline, 4 months

Title

Change in high-sensitivity troponin (hsTroponin)

Time Frame

Baseline, 4 months

Title

Change in high-sensitivity c-reactive protein (hsCRP)

Time Frame

Baseline, 4 months

Title

Change in hemoglobin A1c (HbA1c)

Time Frame

Baseline, 4 months

Title

Change in insulin resistance score (LP-IR)

Time Frame

Baseline, 4 months

Other Pre-specified Outcome Measures:

Title

Change in weight

Time Frame

Baseline, 4 months

Title

Change in blood pressure

Description

Both systolic and diastolic blood pressure will be assessed

Time Frame

Baseline, 4 months

Title

Change in Dietary intake (2005-Block Questionnaire)

Time Frame

Baseline, 4 months

Title

Change in microbiome profile

Time Frame

Baseline through 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Mentz, MD, FACC, FAHA, FHFSA

Organizational Affiliation

Duke Cardiovascular Disease Fellowship

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Health System

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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