A Phase 3 interventional study of Whole Egg in Cardiovascular Diseases, sponsored by Penn State University. Active, not recruiting at 1 site in United States. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Penn State University · Phase 3, Interventional, and Prevention
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's planned enrollment of 65 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
Drug: Whole Egg
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)
Drug: Whole Egg
Whole Large, Grade A Egg
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).
Time frame: 4 weeks
Triglyceride change
Assessed from fasting blood draw expressed in mg/dL.
Time frame: 4 weeks
Total cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Time frame: 4 weeks
HDL-cholesterol change
Assessed from fasting blood draw expressed in mg/dL.
Time frame: 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
Time frame: 4 weeks
Change in particle size and number of LDL, HDL, VLDL and chylomicrons
Measured via Nuclear Magnetic Resonance
Time frame: 4 weeks
Change in central systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Time frame: 4 weeks
Change in brachial systolic and diastolic blood pressure
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Time frame: 4 weeks
Change in fasting serum insulin
Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml
Time frame: 4 weeks
Change in fasting plasma glucose concentration
Glucose assessed in a fasting blood draw and expressed in mg/dL
Time frame: 4 weeks
Change in Fructosamine
Fructosamine assess in a fasting blood draw and expressed in micro IU/ml
Time frame: 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
Time frame: 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.
Time frame: 4 weeks
Change in trimethylamine N-oxide (TMAO)
Measured in fasting blood. Expressed as µmol/L
Time frame: 4 weeks
Change in choline
Measured in fasting blood. Expressed as µmol/L
Time frame: 4 weeks
Change in carnitine
Measured in fasting blood. Expressed as µmol/L
Time frame: 4 weeks
Change in the composition of the gut microbiota
Abundance measured using 16 s rRNA sequencing
Time frame: 4 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Analytic code
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Penn State University