NCT04642742Unknown不适用
Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
Piper Biosciences, Inc.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- % change in LDL-C from baseline
研究概览
简要总结
The purpose of this study is to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in reducing LDL-C cholesterol in a real word setting.
详细描述
While the safety and benefits of plant sterol supplements have been established and are incorporated into many lipid lowering guidelines, there have been few prior studies of plant sterol chewables in gummy format among real world subjects. In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation in a real world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an adult ≥18 years of age who continuously used the sponsor's product for at least 10 weeks prior to the Follow-on Lipid Test
- •Baseline Lipid Test conducted within past 2 years
- •If smoker, smoking status or frequency has not changed between two lipid test dates
- •Subject understands the study procedures and signs forms documenting informed consent
排除标准
- •Subject was taking a prescription cholesterol-lowering medication or taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin or omega-3 fatty acid supplements at the time of either lipid test
- •Subject does not read English
结局指标
主要结局
% change in LDL-C from baseline
时间窗: >10 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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