NCT01415388已完成不适用
A Double-blind, Randomized, Multi-centre, Placebo-controlled Study to Investigate the Effects of Superba(TM) Krill Oil on Fasting Serum Triglycerides
Aker BioMarine Human Ingredients AS3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Change in fasting serum triglycerides
研究概览
简要总结
The purpose of this study is to assess the effect of 12 weeks of daily supplementation with Superba(TM) Krill Oil on fasting serum triglyceride levels and omega-3 index in subjects whose habitual fatty fish and seafood intake is low and who have borderline high or high fasting serum triglyceride levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(not limited to):
- •General good health with no existing co-morbidities
- •Body mass index (BMI) less than 35 kg/m²
- •Borderline high or high fasting serum triglycerides
- •Clinically normal findings for hematology, clinical chemistry, and urinalysis
- •Be willing to maintain dietary habits and physical activity levels throughout the trial period (next 4 months)
- •Have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less
排除标准
- •(not limited to):
- •Familial hypercholesterolemia or severely high total cholesterol levels
- •History or presence of significant cardiovascular disease or co-morbidities
- •Known allergy to crustaceans (shellfish)
- •Bleeding disorders
- •Disturbed absorption due to changes in the gastrointestinal tract
- •Participation in a clinical trial with an investigational product within 30 days before screening
- •Present or recent use (within 3 months of screening or the first screening visit, if applicable) of any medication which is a known lipid modifying agent or any dietary supplements that affect the level of blood cholesterol and triglycerides
- •Current or recent diet, which in the opinion of the Investigator, deviates from a normal diet (e.g., vegetarians may be acceptable, vegans are not acceptable)
- •Female patients that are pregnant or nursing or females of childbearing potential who are not on a method of birth control acceptable to the Investigator during treatment
- •Patients with known coagulopathy or receiving anticoagulant therapy or co-morbidity that would interfere with the study results
- •Frequency of fatty fish and/or seafood consumption is greater than twice per month
- •Present or recent use of any long-chain omega-3 fatty acid supplement
- •Peri-menopausal women or post-menopausal women taking hormone replacement therapy
- •Patients who test positive for human immunodeficiency virus (HIV) or hepatitis B or C
- •Systolic blood pressure greater than 159 mmHg or diastolic blood pressure greater than 99 mmHg or use of anti-hypertensive medication
- •Diabetic subjects
- •Staff of Cetero Research
结局指标
主要结局
Change in fasting serum triglycerides
时间窗: Baseline (Day 1) and at Day 85
次要结局
- Omega-3 index(At Days 1, 42, and 85)
研究者
研究点 (3)
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