Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Whole Egg
  Whole Large, Grade A Egg

Первичные конечные точки

• LDL-cholesterol change [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Triglyceride change [Срок оценки: 4 weeks]
• Total cholesterol change [Срок оценки: 4 weeks]
• HDL-cholesterol change [Срок оценки: 4 weeks]
• LDL-cholesterol to HDL-cholesterol ratio change [Срок оценки: 4 weeks]
• Change in particle size and number of LDL, HDL, VLDL and chylomicrons [Срок оценки: 4 weeks]
• Change in central systolic and diastolic blood pressure [Срок оценки: 4 weeks]
• Change in brachial systolic and diastolic blood pressure [Срок оценки: 4 weeks]
• Change in fasting serum insulin [Срок оценки: 4 weeks]
• Change in fasting plasma glucose concentration [Срок оценки: 4 weeks]
• Change in Fructosamine [Срок оценки: 4 weeks]
• Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Срок оценки: 4 weeks]
• Change in carotid-femoral pulse wave velocity [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• The Pennylvania State University — University Park

Идентификаторы

NCT: NCT06120400 · HDE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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