Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Cardiovascular Diseases Clinical Trial

Official title:

Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120400
• Other study ID #: HDE
• Status: Recruiting
• Phase: Phase 3
• Start date: April 25, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Penn State University
• Contact: Kristina Petersen, PhD
• Phone: 814-865-7206
• Email: kup63[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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 visits

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Whole Egg
Whole Large, Grade A Egg

Locations

Country	Name	City	State
United States	The Pennylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the composition of the gut microbiota	Abundance measured using 16 s rRNA sequencing	4 weeks
Primary	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).	4 weeks
Secondary	Triglyceride change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
Secondary	Total cholesterol change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
Secondary	HDL-cholesterol change	Assessed from fasting blood draw expressed in mg/dL.	4 weeks
Secondary	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	4 weeks
Secondary	Change in particle size and number of LDL, HDL, VLDL and chylomicrons	Measured via Nuclear Magnetic Resonance	4 weeks
Secondary	Change in central systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Secondary	Change in brachial systolic and diastolic blood pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Secondary	Change in fasting serum insulin	Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/ml	4 weeks
Secondary	Change in fasting plasma glucose concentration	Glucose assessed in a fasting blood draw and expressed in mg/dL	4 weeks
Secondary	Change in Fructosamine	Fructosamine assess in a fasting blood draw and expressed in micro IU/ml	4 weeks
Secondary	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	4 weeks
Secondary	Change in carotid-femoral pulse wave velocity	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.	4 weeks
Secondary	Change in trimethylamine N-oxide (TMAO)	Measured in fasting blood. Expressed as µmol/L	4 weeks
Secondary	Change in choline	Measured in fasting blood. Expressed as µmol/L	4 weeks
Secondary	Change in carnitine	Measured in fasting blood. Expressed as µmol/L	4 weeks