NCT04529174已完成不适用
Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- HDL-FX test HDL-FX test
研究概览
简要总结
Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and non-pregnant female patients or female patients of childbearing age on contraception age 18-80years.
- •Total HDL level 38mg/dL or lower in men and HDL 45 mg/dL or lower in women and a low HDL-P defined as less than 7000 by Spectracell LPP Plus.
- •CHL HDL Fx score equal to or greater than 0.
- •Patients will remain on their present diet, exercise program, medications (except for those who alter serum lipids) sleeping habits, alcohol intake, caffeine intake, smoking amount and emotional status as best as possible related to stress and anxiety and maintain body weight at baseline visit as best as possible to avoid confounding variables.
- •No other lipid lowering supplement can be taken during the study.
- •All lipid lowering supplements must have been discontinued at least 30 days prior t o study entry.
排除标准
- •Pregnant females
- •Females of childbearing age not on an accepted contraception control method
- •Previous myocardial infarction within 5 years
- •Unstable angina
- •Previous stroke or TIA within 5 years
- •Uncompensated congestive heart failure
- •Previous PCTA or stent within 5 years
- •Previous CABG within 5 years
- •Patients on statins, fibrates, or other lipid lowering medications or any supplement known to affect serum lipids.
- •Known or previous cancer within 5 years
- •Type 1 diabetes mellitus
- •Kidney disease as defined by serum creatinine over 2.5 mg/dL
结局指标
主要结局
HDL-FX test HDL-FX test
时间窗: Change from Baseline to End of Study (week 12)
Reverse Cholesterol Transport (RCT)(CEC) with Cleveland Heart Lab (CHL)
HDL mapping
时间窗: Change from Baselineto End of study (week 12)
HDL mapping with Boston Heart Lab (BHL)
次要结局
- LP-PLA-2 test(Change from Baseline to End of Study (week 12))
- Dietary Intake(Change from Baseline to End of Study (week 12))
- Myloperoxidase (MPO)(Change from Baseline to End of Study (week 12))
研究者
研究点 (2)
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