A Multicenter Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- LDL Reduction
研究概览
简要总结
Great controversy exists about the feasibility and safety of a product that can be employed for self-directed cholesterol reduction. The position that self-directed cholesterol lowering could lead those that do not need lower cholesterol to take the product is likely unfounded. This is because there is no convincing evidence to suggest that there are cholesterol levels so low that a lower one would not be beneficial or conversely be dangerous. Ample evidence exists that cholesterol causes cardiovascular disease and that lower cholesterol places individuals and populations at lower risk. Because of the high cost, insurance concerns and suboptimal access to physician care, a self-directed, effective and safe approach to cholesterol maintenance or reduction would be very desirable. Drug therapy also has been associated with suboptimal results. Though a new concept that addresses cholesterol by several mechanisms simultaneously has been shown to be more consistently effective and with better tolerability, there is still a need for a self-directed cholesterol optimizing alternative. It is, therefore, our intent in this study to evaluate certain foods, specifically nutraceutical containing fruit flavored drinks in the hopes that they can be proven a safe and effective alternative approach for cholesterol management.
详细描述
Cholesterol is the principle component of cardiovascular disease. It deposits in the walls of blood vessels and contributes to both chronic vascular insufficiency manifested as claudication, ischemic ulceration, or angina, and acute vascular insufficiency presenting as heart attack, stroke or sudden death.
Coronary heart disease is the number one killer worldwide. Approximately 50% of males and one-third of females will develop a coronary heart disease related acute event in their lifetime. The cost of coronary heart disease is staggering. In the United States alone, over $120 billion is spent annually in direct and indirect costs attributed to this killer (10).
The Framingham Heart Study has shown that coronary heart disease incidence rises proportionately to serum cholesterol (1). More importantly, numerous studies demonstrate a reduction in coronary heart disease related events with falling cholesterol levels on treatment (18).
There are four classes of commonly used cholesterol lowering drugs:
- statins
- fibric acid derivates
- niacin
- bile acid sequestrants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects will need to be on their usual diet and
- •Not have been on any cholesterol lowering medications for at least two months or eight weeks prior to randomization. The subjects will also need to be off of all dietary supplements or vitamins containing any of the constituents in any of the formulations for the same time period.
- •Any baseline cholesterol measurement will be acceptable since there is no convincing evidence of low cholesterol below which a clinical benefit is thought not to occur, nor cellular function compromised,.
- •Males 20 to 80 years of age will be acceptable.
- •Post menopausal females 55 to 80 years of age.
排除标准
- •Prior myocardial infarction clinically or by EKG criteria including left bundle branch block.
- •History of angina.
- •History of abnormal stress test consistent with ischemia or myocardial infarction.
- •Diabetes (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
- •Peripheral vascular disease (because of the generally accepted significant association with previously undiagnosed coronary artery disease).
- •History of prior allergy or sensitivity to any component of any formulation.
- •Those taking medications of the following types or closely related medications:
- •cyclosporins
- •Azole antifungals
- •macrolide antibiotics
- •anti-arrhythmic medications
- •protease inhibitors
- •Seizure medication
- •Pre-randomization CPK greater than the upper limits of normal.
- •History of hepatitis or unexplained elevation of transaminase LFTs.
- •History of musculoskeletal condition with weakness or pain, i.e., arthritis, myositis, myalgia, fibromyalgia or PMR.
- •Active cancer or vasculitis on therapy.
- •Inability to provide informed consent.
- •Premenopausal women, women who are pregnant, may become pregnant or nursing mothers will be excluded because of the unknown effects of nutraceuticals on the fetus or newborn.
- •Any travel plans by the subject that would affect compliance with the study protocol.
- •History of a seizure disorder.
- •End stage renal disease (or renal failure).
- •Any subject who the investigator determines that discontinuing current cholesterol lowering treatment for the 16 weeks (8 weeks each for a wash out and study participation) of the study would not be safe or otherwise in the best interest of the subject.
结局指标
主要结局
LDL Reduction
时间窗: 8 weeks
The primary end point will be relative LDL and total cholesterol reductions, i.e., the placebo subtracted reduction in these parameters.
次要结局
- HDL change from control formulation(8 weeks)
- CRP change from control formulation(8 weeks)
- Triglyceride reduction from control formulation(8 weeks)
研究者
Dr. Mitchell Karl
Principal Investigator
Healthy Drink Discoveries, Inc.