Eggs for Heart Health

Overseen By Stacey Meily

Age: 18 - 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Penn State University

Must not be taking: Antihypertensives, Lipid-lowering, Glucose-lowering, others

Disqualifiers: Diabetes, Cardiovascular event, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking anti-hypertensive, lipid-lowering, or glucose-lowering medications, you cannot participate in this trial. If you take supplements that affect heart health and are unwilling to stop during the study, you also cannot participate.

What data supports the effectiveness of the treatment Whole Egg for heart health?

Research suggests that eating one egg a day does not increase heart disease risk for most people and may even help improve cholesterol balance by increasing good cholesterol (HDL). Additionally, egg consumption is linked to a lower risk of stroke, especially in men. ^{1 2 3 4 5}

Is eating eggs generally safe for heart health?

Research shows that eating up to one egg a day does not increase the risk of heart disease and may even lower the risk of stroke. Studies found no short-term harmful effects on heart health from daily egg consumption, even in people at risk of heart disease. ^{3 6 7 8 9}

How does the treatment of whole eggs differ from other treatments for heart health?

The treatment using whole eggs is unique because it involves dietary intake rather than medication, and it may improve heart health by increasing good cholesterol (HDL) and maintaining a healthy balance of cholesterol types without raising bad cholesterol (LDL) levels. Unlike traditional treatments that often focus on reducing cholesterol intake, this approach suggests that consuming up to three eggs a day can have beneficial effects on heart health markers. ^{3 5 10 11 12}

What is the purpose of this trial?

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.

Research Team

Kristina Petersen

Principal Investigator

The Pennsylvania State University

Eligibility Criteria

This trial is for adults with a BMI of 25-35, eating less than 14 eggs per week, stable weight in the last 6 months, and certain levels of cholesterol, blood sugar, and blood pressure. It's not for those outside these health ranges.

Inclusion Criteria

Blood pressure <140/90 mmHg

My weight has been stable, changing less than 10% in the last 6 months.

Intake of <14 eggs/week for the prior 3 months

Exclusion Criteria

I haven't had cancer recurrence in over 10 years, or non-melanoma skin cancer in over 5 years.

Participation in another clinical trial within 30 days of baseline

Food allergies/intolerance/sensitives/dislikes of foods included in the study menu

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants follow a healthy diet containing 2 eggs per day for 4 weeks

4 weeks

Regular monitoring visits

Washout

Participants undergo a washout period to clear any effects of the first diet

2-4 weeks

Treatment Period 2

Participants follow a healthy diet containing 3 eggs per week for 4 weeks

4 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Whole Egg

Trial Overview The study tests heart health effects from eating a healthy diet with either 2 eggs daily or just 3 eggs weekly over a period of four weeks.

Participant Groups

Group I: Healthy Diet + Eggs (HD+E) Experimental Treatment 1 Intervention

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal

Group II: Healthy Diet (HD) Active Control 1 Intervention

2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

American Egg Board

Collaborator

Trials

30

Recruited

62,100+

Findings from Research

Recent cohort studies indicate that consuming one egg a day does not increase cardiovascular risk for most people, despite past concerns about dietary cholesterol.

Intervention studies suggest that egg consumption is safe and may even improve lipid profiles in both healthy individuals and those with cardiometabolic diseases, although caution is advised for diabetic patients regarding high egg intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg intake and cardiovascular disease: a scientifi c literature review Dussaillant, C., Echeverría, G., Rozowski, J., et al.[2018]

Consuming more than 4 whole eggs per week does not significantly impact cardiovascular disease (CVD) risk factors compared to consuming 4 or fewer eggs, indicating that whole egg intake may be safe for middle-aged and older adults.

In contrast, eating more than 4 whole eggs per week leads to higher levels of total cholesterol, HDL, and LDL compared to equivalent amounts of egg substitutes, suggesting that egg substitutes may be a better option for lowering CVD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of whole egg intake on blood pressure, lipids and lipoproteins in middle-aged and older population: A systematic review and meta-analysis of randomized controlled trials. Wang, MX., Wong, CH., Kim, JE.[2020]

A review of 17 studies involving 556 subjects found that increasing dietary cholesterol by 100 mg per day raises the ratio of total to HDL cholesterol, which can negatively impact cholesterol profiles.

The results suggest that limiting dietary cholesterol, such as from egg consumption, may still be advisable to maintain a healthier cholesterol balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cholesterol from eggs increases the ratio of total cholesterol to high-density lipoprotein cholesterol in humans: a meta-analysis. Weggemans, RM., Zock, PL., Katan, MB.[2022]

In a study of 23,524 U.S. adults, egg consumption was not linked to total or coronary heart disease (CHD) mortality, suggesting that eating eggs may not increase the risk of these outcomes.

Interestingly, higher egg intake was associated with a 66% lower risk of stroke mortality in males, while also being linked to increased risks of type 2 diabetes and hypertension, indicating a complex relationship between egg consumption and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg Consumption and Risk of Total and Cause-Specific Mortality: An Individual-Based Cohort Study and Pooling Prospective Studies on Behalf of the Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group. Mazidi, M., Katsiki, N., Mikhailidis, DP., et al.[2020]

Research indicates that egg consumption does not universally increase the risk of coronary heart disease, as 70% of people (hyporesponders) show little to no change in plasma cholesterol levels after eating eggs.

Eggs can promote the formation of larger, less harmful LDL particles and increase beneficial antioxidants like lutein and zeaxanthin, suggesting that they may have protective effects, especially for eye health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cholesterol provided by eggs and plasma lipoproteins in healthy populations. Fernandez, ML.[2019]

A systematic review of 24 studies involving nearly 12 million participants found that consuming one additional egg per day is associated with a 6% increased risk of all-cause mortality, particularly in women and Americans with adjusted hyperlipidemia.

Egg consumption was linked to a higher risk of cardiovascular disease (CVD) mortality in individuals over 60 years old, but no significant associations were found for ischemic heart disease or stroke mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Egg Consumption with Risk of All-Cause and Cardiovascular Disease Mortality: A Systematic Review and Dose-Response Meta-Analysis of Observational Studies. Ma, W., Zhang, Y., Pan, L., et al.[2023]

In a study of 37,121 US adults over a median follow-up of 7.8 years, no significant link was found between egg consumption and overall or heart disease mortality, suggesting that eating eggs may not negatively impact health outcomes.

The relationship between dietary cholesterol intake and all-cause mortality varied based on baseline intake levels: lower cholesterol intake (<250 mg/day) was associated with reduced mortality risk, while higher intake (≥250 mg/day) was linked to increased mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Intakes of Eggs and Cholesterol in Relation to All-Cause and Heart Disease Mortality: A Prospective Cohort Study. Xia, PF., Pan, XF., Chen, C., et al.[2021]

In a study of 32 adults with coronary artery disease, daily consumption of eggs for 6 weeks showed no negative impact on cardiac risk factors such as endothelial function, cholesterol levels, blood pressure, or body weight.

The results suggest that including eggs in the diet does not pose additional risks for heart health in individuals already diagnosed with coronary artery disease, challenging previous dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial. Katz, DL., Gnanaraj, J., Treu, JA., et al.[2014]

A meta-analysis of 7 studies found that consuming up to one egg daily is associated with a 12% decreased risk of stroke, suggesting that moderate egg intake may be beneficial for stroke prevention.

The same analysis showed no significant association between egg consumption and the risk of coronary heart disease (CHD), indicating that eating eggs does not increase the risk of heart problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of Egg Consumption and Risk of Coronary Heart Disease and Stroke. Alexander, DD., Miller, PE., Vargas, AJ., et al.[2020]

In a study of 9,263 Japanese adults followed for 14 years, higher egg consumption was associated with lower total cholesterol levels in women, suggesting a potential link between egg intake and cholesterol management.

Women who consumed 1-2 eggs per week had significantly lower all-cause mortality compared to those who ate one egg per day, indicating that moderate egg consumption may be beneficial for health, particularly in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg consumption, serum cholesterol, and cause-specific and all-cause mortality: the National Integrated Project for Prospective Observation of Non-communicable Disease and Its Trends in the Aged, 1980 (NIPPON DATA80). Nakamura, Y., Okamura, T., Tamaki, S., et al.[2023]

In a 14-week study with 38 healthy young adults, increasing egg intake to 3 eggs per day led to beneficial changes in cardiovascular disease (CVD) risk biomarkers, including increased HDL cholesterol and decreased LDL cholesterol levels.

Despite the increase in egg consumption, there were no adverse changes in plasma TMAO levels or LDL cholesterol, suggesting that eating up to 3 eggs a day can be safe and beneficial for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of up to 3 Eggs/Day Increases HDL Cholesterol and Plasma Choline While Plasma Trimethylamine-N-oxide is Unchanged in a Healthy Population. DiMarco, DM., Missimer, A., Murillo, AG., et al.[2021]

In a 26-week double-blind study involving military personnel with high cholesterol, those who consumed a drink containing hyperimmune egg protein showed no significant increase in total cholesterol levels, while control and placebo groups did.

The hyperimmune egg drink also helped maintain stable levels of important lipoproteins, suggesting it may help reduce the risk of cardiovascular diseases by positively influencing serum lipoprotein regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study on the effect of hyperimmune egg protein on elevated cholesterol levels and cardiovascular risk factors. Karge, WH., Deluca, JP., Marchitelli, LJ., et al.[2009]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Egg intake and cardiovascular disease: a scientifi c literature review [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of whole egg intake on blood pressure, lipids and lipoproteins in middle-aged and older population: A systematic review and meta-analysis of randomized controlled trials. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary cholesterol from eggs increases the ratio of total cholesterol to high-density lipoprotein cholesterol in humans: a meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Egg Consumption and Risk of Total and Cause-Specific Mortality: An Individual-Based Cohort Study and Pooling Prospective Studies on Behalf of the Lipid and Blood Pressure Meta-analysis Collaboration (LBPMC) Group. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Dietary cholesterol provided by eggs and plasma lipoproteins in healthy populations. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Association of Egg Consumption with Risk of All-Cause and Cardiovascular Disease Mortality: A Systematic Review and Dose-Response Meta-Analysis of Observational Studies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Dietary Intakes of Eggs and Cholesterol in Relation to All-Cause and Heart Disease Mortality: A Prospective Cohort Study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of egg ingestion on endothelial function in adults with coronary artery disease: a randomized, controlled, crossover trial. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of Egg Consumption and Risk of Coronary Heart Disease and Stroke. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Egg consumption, serum cholesterol, and cause-specific and all-cause mortality: the National Integrated Project for Prospective Observation of Non-communicable Disease and Its Trends in the Aged, 1980 (NIPPON DATA80). [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Intake of up to 3 Eggs/Day Increases HDL Cholesterol and Plasma Choline While Plasma Trimethylamine-N-oxide is Unchanged in a Healthy Population. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Pilot study on the effect of hyperimmune egg protein on elevated cholesterol levels and cardiovascular risk factors. [2009]