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HypercholesterolemiaPROSPERITYNCT04673721

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

A study testing Fortified eggs, Intermittent fasting and Non-egg supplemented in people with Hypercholesterolemia and Hyperlipidemia, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Fortified eggs, Intermittent fasting and Non-egg supplemented
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteUnited States
Study dates
6 Jan 2021to 13 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Health System

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Being tested
Fortified eggs, Intermittent fasting, Non-egg supplemented, Usual care diet
Keywords
Fortified eggs, High cholesterol
Medical subject headings
Hypercholesterolemia, Hyperlipidemias, Avitaminosis, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fortified eggsDietary supplement

    Average 12 eggs consumed per week

  • Intermittent fastingBehavioural

    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 supplementedDietary supplement

    2 or less eggs consumed per week

  • Usual care dietBehavioural

    Consistency with current diet without consideration of intermittent fasting

Study groups in NCT04673721
Study groupRoleWhat they receive
Fortified eggs + Intermittent fastingActive comparatorConsume at least 12 fortified eggs per week with 16-hour fast and then an 8-hour nutritional window.
Receives: Dietary Supplement: Fortified eggs; Behavioral: Intermittent fasting
Non-egg supplemented diet + Intermittent fastingActive comparatorMaintain consumption of 2 or less eggs per week with 16-hour fast and then an 8-hour nutritional window.
Receives: Behavioral: Intermittent fasting; Dietary Supplement: Non-egg supplemented
Fortified eggs + Usual care dietActive comparatorConsume at least 12 fortified eggs per week with consistency with current diet.
Receives: Dietary Supplement: Fortified eggs; Behavioral: Usual care diet
Non-egg supplemented diet + Usual care dietPlacebo comparatorMaintain consumption of 2 or less eggs per week with consistency with current diet.
Receives: Dietary Supplement: Non-egg supplemented; Behavioral: Usual care diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LDL-cholesterol

    Measured: Baseline, 4 months

  2. Change in HDL-cholesterol

    Measured: Baseline, 4 months

Secondary outcomes (15)

  1. Change in total cholesterol

    Measured: Baseline, 4 months

  2. Change in triglycerides

    Measured: Baseline, 4 months

  3. Change in NMP LipoProfile

    Measured: Baseline, 4 months

  4. Change in lipoprotein subfractionation

    Measured: Baseline, 4 months

  5. Change in apolipoprotein B

    Measured: Baseline, 4 months

  6. Change in fatty acid profile

    Measured: Baseline, 4 months

  7. Change in Vitamin B2 level

    Measured: Baseline, 4 months

  8. Change in Vitamin B12 level

    Measured: Baseline, 4 months

  9. Change in Vitamin D level

    Measured: Baseline, 4 months

  10. Change in Vitamin E level

    Measured: Baseline, 4 months

  11. Change in selenium level

    Measured: Baseline, 4 months

  12. Change in high-sensitivity troponin (hsTroponin)

    Measured: Baseline, 4 months

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

    Measured: Baseline, 4 months

  14. Change in hemoglobin A1c (HbA1c)

    Measured: Baseline, 4 months

  15. Change in insulin resistance score (LP-IR)

    Measured: Baseline, 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start6 Jan 2021
  3. Primary completion13 Dec 2022
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673721
Sponsor's protocol ID
Pro00105996
Acronym
PROSPERITY
Status last verified
Jan 2023
First submitted
9 Dec 2020
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nouhravesh N, Harrington J, Aberle LH, Green CL, Voss K, Holdsworth D, Misialek K, Slaugh BT, Wieand M, Yancy WS Jr, Pagidipati N, Mentz RJ. Effects of fortified eggs and time-restricted eating on cardiometabolic health: The prosperity trial. Am Heart J. 2025 Jan;279:27-39. doi: 10.1016/j.ahj.2024.10.005. Epub 2024 Oct 15.

    PubMed 39414223

Questions about this trial

What is this clinical trial studying?

A study testing Fortified eggs, Intermittent fasting and Non-egg supplemented in people with Hypercholesterolemia and Hyperlipidemia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LDL-cholesterol (time frame: Baseline, 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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