NCT01583582已完成2 期
Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Marealis AS
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- change in systolic blood pressure
研究概览
简要总结
The purpose of this proof of concept study is to find out the efficacy of Marealis Refined Peptide Concentrate (RPC) from Coldwater Shrimp (Pandalus borealis) containing ACE-inhibiting peptides on blood pressure in subjects with mild or moderate hypertension.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild or moderate hypertension (systolic blood pressure 130 - 160 mmHg and diastolic blood pressure ≤ 100 mmHg)
- •age 30 - 75 years
- •body weight ≥ 60 kg
- •stable body weight
- •use of effective contraception in women of childbearing potential
排除标准
- •body mass index ≥ 35
- •antihypertensive drug treatment, regular high dose NSAID treatment and the use of cyclosporine or tacrolimus
- •diabetes (type 1 and 2)
- •anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, clinically significant biochemistry, any other clinically significant hematology and/or biochemistry at the investigator's discretion
- •cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening) including stroke and congestive heart failure
- •secondary hypertension history of cancer or malignant disease within the past five years
- •any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subjects
- •fish and other seafood allergies, citrus allergy, multiple food allergies
- •alcohol abuse
- •smokers and tobacco/snuff/nicotine users
- •consumption of food supplements targeted to blood pressure lowering within 30 days before randomization
- •pregnant and lactating mothers, women, planning for pregnancy during the study
- •participation in clinical trials 30 days prior to this study and participation in other clinical intervention
结局指标
主要结局
change in systolic blood pressure
时间窗: from baseline after 8 weeks of treatment
change from baseline after 8 weeks of treatment in systolic office blood pressure
次要结局
- mean heart rate(at the end of a 8-week treatment)
- mean fasting plasma glucose concentration(at the end of a 8-week treatment)
- blood count(at the end of a 8-week treatment)
- mean systolic blood pressure(at the end of a 8-week treatment)
- mean fasting plasma lipids concentration(at the end of a 8 week treatment)
- change in diastolic blood pressure(from baseline after 8 weeks of treatment)
- mean serum C-reactive protein(at the end of a 8-week treatment)
- mean diastolic blood pressure(at the end of a 8-week treatment)
- change in systolic blood pressure(from the baseline after 2 weeks treatment)
- diastolic blood pressure(from baseline after 2 weeks treatment)
- plasma glutamyltransferase(at the end of a 8-week treatment)
- plasma creatinine(at the end of a 8-week treatment)
- plasma sodium concentration(at the end of a 8-week treatment)
- plasma potassium concentration(at the end of a 8-week treatment)
- adverse events(during the 8-week treatment)
研究者
研究点 (2)
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