A Randomized, Prospective, Double-Blinded, Comparative Clinical Study to Evaluate the Safety and Efficacy of the Neuherbs Deep-sea Fish oil Compared with Placebo in Adults.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Reduction in hsCRP levels between the two treatment arms at day 60 and day 90 of intervention
研究概览
简要总结
Background and Introduction
Cardiovascular diseases (CVDs) are a major global cause of death, with high cholesterol levels playing a significant role. Elevated cholesterol is linked to increased risks of ischemic heart disease and stroke, contributing to millions of deaths annually. Specifically, higher levels of triglycerides (TG) and low-density lipoprotein (LDL) increase CVD risk, while low levels of high-density lipoprotein (HDL) further exacerbate this risk. Consequently, modifying lipid profiles is a key strategy in preventing CVDs, achievable through medical interventions or dietary changes.
Omega-3 poly-unsaturated fatty acids (PUFAs), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are notable for their cardiovascular benefits. The American Heart Association (AHA) recommends DHA and EPA intake for secondary prevention of cardiovascular events, and the FDA approves omega-3 supplementation for managing high triglyceride levels.
In addition to their effects on lipid profiles, omega-3 PUFAs have significant anti-inflammatory properties, inhibiting key inflammatory processes and producing mediators that resolve inflammation. These actions are crucial in managing conditions linked to chronic inflammation, contributing to the overall cardiovascular benefits of omega-3 fatty acids.
Purpose of the Study
The purpose of this study is to evaluate the impact of Neuherbs Deep-sea Fish Oil on lipid profiles and inflammation. Specifically, the study aims to assess the effects of this omega-3 PUFA supplement on key cardiovascular risk factors, including LDL, HDL, triglycerides, and various inflammatory markers. By understanding the potential benefits of Neuherbs Deep-sea Fish Oil, the study seeks to contribute to the growing body of evidence supporting the role of omega-3 fatty acids in cardiovascular health and inflammation management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of both sexes aged between 30 to 65 yrs.
- •2.BMI ranging from 25 to 30 Kg per m2 3.LDL Cholesterol level 1.3g per liter to 1.89g per liter.
排除标准
- •1.Pregnant or lactating women.
- •2.Patients currently taking lipid lowering drugs (including statins, fibrates.
- •3.Patients with high serum triglycerides (defined by more than 250 mg per dL) 4.Patients with any neoplastic, cardiovascular disorder or other concurrent medical illness (malabsorptive disorders, acute and chronic inflammation) confirmed based on medical history, physical examination and recent routine laboratory tests such as CBC and Urinalysis.
- •5.Patients with known history of hypersensitivity to the study drugs.
- •6.Alcoholic consumers and smokers 7.Currently or has been taking an investigational drug in the past 30 days.
结局指标
主要结局
1.Reduction in hsCRP levels between the two treatment arms at day 60 and day 90 of intervention
时间窗: Day 0, 30, 60 and 90
2.Reduction in Lipid Profile values between the two treatment arms at day 60 and day 90 of intervention
时间窗: Day 0, 30, 60 and 90
次要结局
- 1.Change in BMI and body weight between the two treatment arms at day 60 and day 90 of intervention(2.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) between the two treatment arms)
研究者
Dr Manjunath U
Good Life hospital