A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Safety, Efficacy and Tolerability of PreLipid®, a Twice-daily Nutritional Supplement in Subjects With Higher Than Normal Blood Lipid Levels
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 16
- 主要终点
- Safety of Dietary Supplement PreLipid 600 mg twice-daily
研究概览
简要总结
Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels
详细描述
A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories:
- •Age ≥ 18 years to ≤ 65 years
- •LDL cholesterol levels >120mg/dl
- •Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures -
排除标准
- •Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.
- •Cardiac status New York Heart Association class III-IV
- •Uncotrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
- •Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
- •Clinically significant peripheral edema
- •Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
- •Participants on steroid
- •Pregnancy or lactating women
- •Known hypersensitivity to any of the study drugs
- •Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
- •Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
- •Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study
- •Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.
结局指标
主要结局
Safety of Dietary Supplement PreLipid 600 mg twice-daily
时间窗: Day 1(Baseline) to Day 90 (End of Study)
Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90)
Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels
时间窗: Day 1 (Baseline) to Day 90 (End of Study)
Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days
次要结局
- Changes in Glycemic Status(Day 1 (Baseline) to Day 90 (End of Study))
研究者
Joe Fenn
Chairman, Department of Clinical & Preventive Cardiology
Medanta, The Medicity, India