Clinical trial NCT06120400: Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
Official title: Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiovascular Diseases
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2023-11-07
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: LDL-cholesterol change
timeFrame: 4 weeks
Secondary outcomes:
measure: Triglyceride change
timeFrame: 4 weeks
measure: Total cholesterol change
timeFrame: 4 weeks
measure: HDL-cholesterol change
timeFrame: 4 weeks
measure: LDL-cholesterol to HDL-cholesterol ratio change
timeFrame: 4 weeks
measure: Change in particle size and number of LDL, HDL, VLDL and chylomicrons
timeFrame: 4 weeks
measure: Change in central systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Change in brachial systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Change in fasting serum insulin
timeFrame: 4 weeks
measure: Change in fasting plasma glucose concentration
timeFrame: 4 weeks
measure: Change in Fructosamine
timeFrame: 4 weeks
measure: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: 4 weeks
measure: Change in carotid-femoral pulse wave velocity
timeFrame: 4 weeks
measure: Change in trimethylamine N-oxide (TMAO)
timeFrame: 4 weeks
measure: Change in choline
timeFrame: 4 weeks
measure: Change in carnitine
timeFrame: 4 weeks
Other outcomes:
measure: Change in the composition of the gut microbiota
timeFrame: 4 weeks
Locations:
city: University Park
country: United States
facility: The Pennylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Kristina Petersen
role: PRINCIPAL_INVESTIGATOR
References: