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NCT06120400 | RECRUITING | Cardiovascular Diseases

Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs
Sponsor:

Penn State University

Information provided by (Responsible Party):

Kristina Petersen PhD, APD, FAHA

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.

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Whole Egg

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 65 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
Actual Study Start Date : 2024-04-25
Estimated Primary Completion Date : 2026-07
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Location Details

NCT06120400

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

The Pennylvania State University

University Park, Pennsylvania, United States, 16802