Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 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 purpose of this intervention study is to investigate the effects of daily egg intake on markers of gut health, high-density lipoprotein (HDL), metabolic, and immune cell profiles in adults with body mass indexes (BMI) in normal and obesity ranges. This study further aims to determine whether egg effects are associated with baseline gut microbiome profiles, and whether egg effects are different between males and females and by BMI status. The study will address the following objectives:
Objective 1: Evaluate the effects of daily egg white vs. whole egg intake on gut health, microbiome, and metabolome profiles.
Objective 2: Evaluate the effects of daily egg white vs. whole egg intake on HDL composition and function.
Objective 3: Evaluate the effects of daily egg white vs. whole egg intake on immune profiles and function in culture (ex vivo).
Participants will be asked to consume egg whites 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 be asked to complete surveys about dietary intake and physical activity, as well as provide blood and stool samples throughout the course of the study.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 基础科学
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 18-50 years old (at time of screening)
- Premenopausal status for women
- Body mass index (BMI) 18.5 to < 25 kg/m2; or ³ 30 kg/m2 and >30% and >40% body fat for men and women, respectively
- Willing to consume whole eggs and egg whites provided during the study on a daily basis, and refrain from other eggs or egg-based foods and beverages during the study
- Do not fit any
排除标准
- <18 years old and ≥ 51 years old
- BMI <18.5, 25-29.9, or body weight < 110 pounds
- Experienced >10% weight change in the past 4 weeks
- Elevated fasting glucose levels (fasting glucose higher than 126 mg/dL) and triglycerides greater than 500 mg/dL, or total cholesterol < 120 mg/dL and HDL- cholesterol < 15 mg/dL
- Self-reported and/or physician-diagnosed history of severe constipation, diabetes mellitus, coronary heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, intestinal or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation, postmenopausal
- Allergy to eggs
- Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedence
- Currently taking lipid-lowering medications (e.g., statins, fibrates), glucose-regulating medications, anti-inflammatory medications (e.g., NSAIDs, corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin), long-term antibiotics or probiotics in the last 3 months or during the intervention
- Active smoker
研究组 & 干预措施
Egg whites
干预措施: Egg whites (Other)
Whole eggs
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
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07844616
- 其他研究编号
- B2025-0404/25-08-494-910, 2025-67017-45105, 2025
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否