Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp (MARE)
2013年1月30日 更新者:Niina Tapola、Marealis AS
Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
74
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Kuopio、芬兰、70210
- Oy Foodfiles Ltd
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Refined peptide concentrate, 1200 mg
Refined peptide concentrate, 1 200 mg, once a day
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
实验性的:Refined peptide concentrate, 2 x 600 mg
Refined peptide concentrate, 600 mg, twice a day
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
安慰剂比较:Refined peptide concentrate, 0 mg
|
1200 mg per os, once a day, 8 weeks
600 mg per os, twice a day, 8 weeks
0 mg per os, daily, 8 weeks
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
change in systolic blood pressure
大体时间:from baseline after 8 weeks of treatment
|
change from baseline after 8 weeks of treatment in systolic office blood pressure
|
from baseline after 8 weeks of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
change in diastolic blood pressure
大体时间:from baseline after 8 weeks of treatment
|
change from baseline after 8 weeks of treatment in diastolic blood pressure
|
from baseline after 8 weeks of treatment
|
mean systolic blood pressure
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
mean diastolic blood pressure
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
change in systolic blood pressure
大体时间:from baseline after 4 weeks treatment
|
from baseline after 4 weeks treatment
|
|
diastolic blood pressure
大体时间:from baseline after 4 weeks treatment
|
from baseline after 4 weeks treatment
|
|
diastolic blood pressure
大体时间:from baseline after 2 weeks treatment
|
from baseline after 2 weeks treatment
|
|
mean heart rate
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
mean fasting plasma glucose concentration
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
mean fasting plasma lipids concentration
大体时间:at the end of a 8 week treatment
|
plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively
|
at the end of a 8 week treatment
|
mean serum C-reactive protein
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
blood count
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
plasma glutamyltransferase
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
plasma creatinine
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
plasma sodium concentration
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
plasma potassium concentration
大体时间:at the end of a 8-week treatment
|
at the end of a 8-week treatment
|
|
adverse events
大体时间:during the 8-week treatment
|
during the 8-week treatment
|
|
change in systolic blood pressure
大体时间:from the baseline after 2 weeks treatment
|
from the baseline after 2 weeks treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任:Essi S Sarkkinen, Ph.D、Oy Foodfiles Ltd
- 首席研究员:Sakari A Nieminen, MD、Oy Foodfiles Ltd
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2012年4月20日
首先提交符合 QC 标准的
2012年4月20日
首次发布 (估计)
2012年4月24日
研究记录更新
最后更新发布 (估计)
2013年1月31日
上次提交的符合 QC 标准的更新
2013年1月30日
最后验证
2013年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- MARE-050312
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.