Trial | NCT01583582  Report issue

Title

Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp
Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    marealis refined peptide ...

  • Study Participants

    74
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.
Study Started
Mar 31
2012
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
Jan 31
2013
Estimate

Dietary Supplement Marealis Refined Peptide Concentrate

1200 mg per os, once a day, 8 weeks

Dietary Supplement Marealis Refined Peptide Concentrate

600 mg per os, twice a day, 8 weeks

Dietary Supplement Marealis Refined Peptide Concentrate

0 mg per os, daily, 8 weeks

Refined peptide concentrate, 1200 mg Experimental

Refined peptide concentrate, 1 200 mg, once a day

Refined peptide concentrate, 2 x 600 mg Experimental

Refined peptide concentrate, 600 mg, twice a day

Refined peptide concentrate, 0 mg Placebo Comparator

Criteria 

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
No Results Posted