ACTRN12619000170123已完成未知
Evaluation of the lipid-lowering effects of the BruMeChol™ dietary supplement in subjects with mild hypercholesterolemia
IRCCS INRCA0 个研究点目标入组 125 人开始时间: 2019年2月5日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit(—)
- 性别
- All
入选标准
- •blood total cholesterol levels between 200 and 250 mg/dL
- •- no history of clinically relevant cardiovascular events
- •- signed informed consent form
排除标准
- •- current therapy with statins or food supplements with lipid-reducing effect
- •- total cholesterol > 250 or < 200 mg/dl;
- •- therapy with anticoagulants;
- •- hypothyroidism, orhyperthyroidism
- •- insulin-dependent diabetes or diabetes associated with macrovascular complications)
- •- intestinal malabsorption;
- •- acute illnesses
- •- neoplastic disease or < 1-year life expectancy;
- •- statin non-related liver disease
- •- severe chronic renal failure
- •- allergy/intolerance to one or more components of dietary supplement or placebo
- •- participation in another clinical trial of intervention in the previous three months.
- •- presence of cognitive disorders and other impediments that do not guarantee the correct adherence to the study treatments;
- •- current or presumed pregnancy and pregnancy planning;
- •- incapacity, impossibility or unavailability to sign the written consent.
研究者
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