Cardiovascular Effects of a Healthy Dietary Pattern Containing Eggs: a Controlled-feeding Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- LDL-cholesterol change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy Diet + Eggs (HD+E)
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 2 eggs/day/2000 kcal
干预措施: Whole Egg (Drug)
Healthy Diet (HD)
2020-2025 Dietary Guidelines for Americans adherent dietary pattern containing 3 eggs/week/2000 kcal (HD)
干预措施: Whole Egg (Drug)
结局指标
主要结局
LDL-cholesterol change
时间窗: 4 weeks
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).
次要结局
- LDL-cholesterol to HDL-cholesterol ratio change(4 weeks)
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(4 weeks)
- Change in carnitine(4 weeks)
- Triglyceride change(4 weeks)
- Change in central systolic and diastolic blood pressure(4 weeks)
- Change in brachial systolic and diastolic blood pressure(4 weeks)
- Total cholesterol change(4 weeks)
- HDL-cholesterol change(4 weeks)
- Change in particle size and number of LDL, HDL, VLDL and chylomicrons(4 weeks)
- Change in Fructosamine(4 weeks)
- Change in carotid-femoral pulse wave velocity(4 weeks)
- Change in trimethylamine N-oxide (TMAO)(4 weeks)
- Change in choline(4 weeks)
- Change in fasting serum insulin(4 weeks)
- Change in fasting plasma glucose concentration(4 weeks)
研究者
Kristina Petersen PhD, APD, FAHA
Associate Professor
Penn State University