Open Label Post-market Evaluation of Orally Dosed AlmegaPL on Cholesterol and Cardio-metabolic Parameters.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Triglyceride change from baseline
研究概览
简要总结
The aim of this study is to assess the effectiveness of Almega PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA), on improving blood markers associated with heart health of iwi customers.
详细描述
The investigational product iwi/Cholesterol is a commercially available capsule-form herbal (algae) supplement containing Almega®PL, a Nannochloropsis algae-derived extract rich in eicosapentaenoic acid (EPA). EPA is a type of omega-3 essential fatty acid known to play a beneficial role in protection against cardiovascular disease.The aim of this study is to assess the effectiveness of AlmegaPL on improving blood markers associated with heart health of iwi customers.The study will involve over 200 male and female new consumers of this product and monitor their blood markers during 6 months of supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New iwi/AlmegaPL subscribers.
排除标准
- •Participants that are already taking AlmegaPL.
- •Participants with serious conditions including but not limited to kidney, neurological, immunological, liver and gastrointestinal disease, any heart condition or diabetes).
- •Any participant attempting conception, pregnant or breastfeeding
结局指标
主要结局
Triglyceride change from baseline
时间窗: From Baseline to Month 6
Fasting triglycerides is measured using Imaware at home cardiovascular test kit
次要结局
- Total Cholesterol change from baseline(From Baseline to Month 6)
- LDL-cholesterol change from Baseline(From Baseline to Month 6)
- HDL-cholesterol change from Baseline(From Baseline to Month 6)
- Fasting glucose(From Baseline to Month 6)
- VLDL-Cholesterol change from Baseline(From Baseline to Month 6)
- hs-CRP change from baseline(From Baseline to Month 6)
- HbA1c change from Baseline(From Baseline to Month 6)