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New treatment option for Cardiovascular Diseases
Official title Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
ClinicalTrials.gov ID: NCT06120400
What this study is testing
What is Whole Egg?
Whole Egg is an investigational medicine, being studied as a potential treatment for cardiovascular diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- University Park, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include University Park, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.