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临床试验/NCT06086795
NCT06086795已完成不适用

Investigating Age-dependent Effects of Egg Intake on HDL and Immune Profiles

University of Connecticut1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Change in serum concentration of large HDL particles between diet periods

研究概览

简要总结

The goal of this intervention study is to determine whether consumption of different fractions of chicken eggs, including egg whites, egg yolks, and whole eggs, confer different changes in markers of HDL function and T cell profiles in younger vs. older men and women. The study will address the following objectives:

  • Objective 1: Determine if daily consumption of egg fractions differentially alter HDL profiles across age groups.
  • Objective 2: Determine if daily consumption of egg fractions differentially alter immune cell profiles across age groups.

Participants will be asked to consume egg whites, egg yolks, and whole eggs on a daily basis for 4-weeks each, and avoid eating eggs for a total of 8 weeks at different points in the study. Participants will additionally be provided guidance on following a generally healthy diet, and will be asked to complete surveys about dietary intake and physical activity, as well as provide blood samples throughout the course of the study.

Researchers will compare whether daily consumption of egg whites, egg yolks, and whole eggs differentially alter markers of HDL function and T cell profiles in younger vs. older adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18-30 years old, or 50-75 years old (at time of screening)
  • •Body mass index (BMI) < 30 kg/m2
  • •Willing to consume whole eggs, egg whites, or egg yolks on a daily basis during study periods, and refrain from eating eggs during other study periods
  • •Do not fit any

排除标准

  • •Exclusion Criteria:
  • •< 18 years old; 31-49 years old; > 75 years old
  • •BMI ≥ 30 kg/m2 or body weight < 110 pounds
  • •Weight changes > 10% over the last 4 weeks
  • •Self-reported history of diabetes, heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation
  • •Allergy or intolerance to eggs, egg components, or egg products
  • •Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedance
  • •Highly elevated fasting lipid and glucose levels (triglyceride levels higher than 500 mg/dL, fasting glucose higher than 126 mg/dL), or total cholesterol < 120 mg/dL and HDL-cholesterol < 15 mg/dL
  • •Currently taking lipid-lowering medications (e.g. statins, fibrates), anti-inflammatory medications (e.g., NSAIDs, corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin)

研究组 & 干预措施

Egg whites

Active Comparator

3 large egg equivalent of liquid egg whites per day for 4 weeks

干预措施: Egg whites (Other)

Egg yolks

Experimental

3 large egg equivalent of liquid egg yolks per day for 4 weeks

干预措施: Egg yolks (Other)

Whole eggs

Experimental

3 large whole eggs per day for 4 weeks

干预措施: Whole eggs (Other)

结局指标

主要结局

Change in serum concentration of large HDL particles between diet periods

时间窗: 4 weeks

Measurement of serum large HDL particles (nmol/L) at the egg-free run-in period and the end of each intervention arm.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Andersen

Associate Professor

University of Connecticut

研究点 (1)

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