Clinical Trial to Assess the Safety and Efficacy of a Combination Red Yeast Rice and Omega-3 (EPA+DHA) to Reduce LDL Cholesterol and Triglyceride Levels in Hypercholesterolemic and Hypertriglyceridemic Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Reduction in LDL levels
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated LDL cholesterol and triglyceride levels.
详细描述
Cardiovascular Disease [CVD] is one of the primary causes of illness, disability and death in Canada and in the United States. Hypercholesterolemia and hypertriglyceridemia are significant risk factors for the development of cardiovascular disease.
The investigational product used in this trial, has been specially formulated to help reduce elevated triglycerides and LDL cholesterol levels, and may provide a natural alternative in the prevention of CVD.
This study is a prospective, 12 week study, where participants will be randomized to receive the treatment, placebo, or a comparator product for a period of 12 weeks. Blood lipids will be analysed at baseline, week 6 and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 30 - 70 years.
- •10-year CAD Risk <10%
- •Elevated blood LDL cholesterol in the range of 3.0 to 5.0 mmol/L [equivalent to 117-195 mg/dl].
- •have elevated TG levels [1.5/L - 4.0mmol/L, or 134 mg/dl - 356 mg/dl].
排除标准
- •Adults aged less than 30, or more than 70 years of age
- •Adults with a 10-year CAD risk >10%
- •Individuals with a pre-existing disease or illness including: heart disease, diabetes, renal disease or cancer
- •Individuals taking CYP3A4 inhibitors [including cyclosporine and danazol].
- •Individuals taking Statin medications, including: Atorvastatin [brand names: Lipitor®, Caduet®]
- •Fluvastatin [brand names: Lescol®, Lescol® XL]
- •Lovastatin [brand names: Advicor ®, Altocor ®, Altoprev ®, Mevacor ®]
- •Pravastatin [brand names: Pravachol® , Pravigard® PAC]
- •Rosuvastatin [brand name: Crestor®]
- •Simvastatin [brand names: Vytorin®, Zocor ®]
- •Individuals with an allergy to fish and/or fish oil, Vitamin E, red yeast rice, coenzyme Q10, soybean oil or any other ingredient in the investigational product [i.e. capsule constituents]
- •Individuals who anticipate, or have planned surgery during the course of the trial
- •Individuals who are taking any other natural health products, particularly those containing vitamin K, high levels of vitamin E or Coenzyme Q10 [individuals on a 4-week wash-out of NHPs will be permitted]
- •Individuals who have consumed fish oil or another type of omega-3 fatty acid supplement one-month prior-to and/or during the course of the study
- •Women who are pregnant or breastfeeding
- •Individuals with a history of migraines
- •Individuals taking blood thinning, or blood pressure medications
- •Individuals who have been diagnosed with statin-induced muscle damage (myopathy)
结局指标
主要结局
Reduction in LDL levels
时间窗: 0 weeks, 6 weeks, 12 weeks
次要结局
- Reduction in TG levels(0 weeks, 6 weeks, 12 weeks)