Cardiovascular DiseasesPhase 3NCT06120400
Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
A Phase 3 study testing Whole Egg in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
Trial summary
This study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Whole Egg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- LDL-C ≥115 mg/dL and ≤190 mg/L
- BMI of 25-35 kg/m2
- Intake of <14 eggs/week for the prior 3 months
- Blood pressure <140/90 mmHg
- Fasting blood glucose <126 mg/dL
- Fasting triglycerides <350 mg/dL
- ≤10% change in body weight in the prior 6 months
Who cannot join
- Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
- Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
- Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
- Diagnosed liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
- Current pregnancy or intention of pregnancy within the next 6 months
Show all 17Show fewer
- Lactation within prior 6 months
- Follows a vegetarian or vegan diet
- Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
- Antibiotic use within the prior 1 month
- Oral steroid use within the prior 1 month
- Use of tobacco or nicotine containing products with in the past 6 months
- Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
- Participation in another clinical trial within 30 days of baseline
- Currently following a restricted or weight loss diet
- Prior bariatric surgery
- Intake of >14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennylvania State University
University Park, Pennsylvania, 16802
About this study
Official title: Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
This study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks.
Read the detailed description
This is a 2-period, randomized, crossover, controlled feeding study examining the effect of 2020-2025 Dietary Guidelines for Americans adherent dietary patterns containing 2 eggs/day/2000 kcal (HD+E) compared to 3 eggs/week/2000 kcal (HD) on biomarkers of cardiovascular health and function after 4 weeks.
- Conditions
- Cardiovascular Diseases
- Being tested
- Whole Egg
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole EggDrug
Whole Large, Grade A Egg
| Study group | Role | What they receive |
|---|---|---|
| Healthy Diet + Eggs (HD+E) | Experimental | 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal Receives: Drug: Whole Egg |
| Healthy Diet (HD) | Active comparator | 2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) Receives: Drug: Whole Egg |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol change
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Secondary outcomes (15)
Triglyceride change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 4 weeks
Total cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 4 weeks
HDL-cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Measured: 4 weeks
LDL-cholesterol to HDL-cholesterol ratio change
LDL-cholesterol and HDL-cholesterol will be measured from a fasting blood draw expressed in mg/dL. The ratio will be calculated as LDL-C divided by HDL-C
Measured: 4 weeks
Change in particle size and number of LDL, HDL, VLDL and chylomicrons
Measured via Nuclear Magnetic Resonance
Measured: 4 weeks
Change in central systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Measured: 4 weeks
Change in brachial systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Measured: 4 weeks
Change in fasting serum insulin
Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml
Measured: 4 weeks
Change in fasting plasma glucose concentration
Glucose assessed in a fasting blood draw and expressed in mg/dL
Measured: 4 weeks
Change in Fructosamine
Fructosamine assess in a fasting blood draw and expressed in micro IU/ml
Measured: 4 weeks
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5
Measured: 4 weeks
Change in carotid-femoral pulse wave velocity
A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.
Measured: 4 weeks
Change in trimethylamine N-oxide (TMAO)
Measured in fasting blood. Expressed as µmol/L
Measured: 4 weeks
Change in choline
Measured in fasting blood. Expressed as µmol/L
Measured: 4 weeks
Change in carnitine
Measured in fasting blood. Expressed as µmol/L
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start25 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
- Investigators
- Kristina Petersen, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120400
- Sponsor's protocol ID
- HDE
- Status last verified
- Sep 2026
- First submitted
- 2 Nov 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
- ClinicalTrials.gov ID
- NCT06120400
- Acronym / sponsor ID
- HDE
- Conditions
- Cardiovascular Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of a healthy diet containing 2 eggs per day compared to a healthy diet containing 3 eggs per week on biomarkers of heart health after 4 weeks.
Detailed description
This is a 2-period, randomized, crossover, controlled feeding study examining the effect of 2020-2025 Dietary Guidelines for Americans adherent dietary patterns containing 2 eggs/day/2000 kcal (HD+E) compared to 3 eggs/week/2000 kcal (HD) on biomarkers of cardiovascular health and function after 4 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Diet + Eggs (HD+E) | Experimental | Drug: Whole Egg2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal |
| Healthy Diet (HD) | Active comparator | Drug: Whole Egg2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD) |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- LDL-C ≥115 mg/dL and ≤190 mg/L
- BMI of 25-35 kg/m2
- Intake of <14 eggs/week for the prior 3 months
- Blood pressure <140/90 mmHg
- Fasting blood glucose <126 mg/dL
Key exclusion criteria (17 listed)
- Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
- Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
- Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
- Diagnosed liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole EggWhole Large, Grade A Egg | Drug | Healthy Diet (HD), Healthy Diet + Eggs (HD+E) |
Primary outcome
LDL-cholesterol change
Time frame: 4 weeks
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 1 and day 2 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
15 secondary outcomes
Triglyceride change
Time frame: 4 weeks
Total cholesterol change
Time frame: 4 weeks
HDL-cholesterol change
Time frame: 4 weeks
LDL-cholesterol to HDL-cholesterol ratio change
Time frame: 4 weeks
Change in particle size and number of LDL, HDL, VLDL and chylomicrons
Time frame: 4 weeks
Change in central systolic and diastolic blood pressure
Time frame: 4 weeks
Change in brachial systolic and diastolic blood pressure
Time frame: 4 weeks
Change in fasting serum insulin
Time frame: 4 weeks
Change in fasting plasma glucose concentration
Time frame: 4 weeks
Change in Fructosamine
Time frame: 4 weeks
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: 4 weeks
Change in carotid-femoral pulse wave velocity
Time frame: 4 weeks
Change in trimethylamine N-oxide (TMAO)
Time frame: 4 weeks
Change in choline
Time frame: 4 weeks
Change in carnitine
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Petersen principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole Egg in people with Cardiovascular Diseases, run by Penn State 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 7 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
LDL-cholesterol change (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.