Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp

Phase 2

Completed

• Conditions: Hypertension; Blood Pressure
• Interventions: Dietary Supplement: Marealis Refined Peptide Concentrate

• Registration Number: NCT01583582
• Lead Sponsor: Marealis AS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Refined peptide concentrate, 2 x 600 mg	Marealis Refined Peptide Concentrate	Refined peptide concentrate, 600 mg, twice a day
Refined peptide concentrate, 0 mg	Marealis Refined Peptide Concentrate	-
Refined peptide concentrate, 1200 mg	Marealis Refined Peptide Concentrate	Refined peptide concentrate, 1 200 mg, once a day

Primary Outcome Measures

Name	Time	Method
change in systolic blood pressure	from baseline after 8 weeks of treatment	change from baseline after 8 weeks of treatment in systolic office blood pressure

Secondary Outcome Measures

Name	Time	Method
mean systolic blood pressure	at the end of a 8-week treatment
change in diastolic blood pressure	from baseline after 8 weeks of treatment	change from baseline after 8 weeks of treatment in diastolic blood pressure
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
mean heart rate	at the end of a 8-week treatment
mean fasting plasma glucose concentration	at the end of a 8-week treatment
mean fasting plasma lipids concentration	at the end of a 8 week treatment	plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively
mean serum C-reactive protein	at the end of a 8-week treatment
blood count	at the end of a 8-week 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

Trial Locations

Locations (1)

Oy Foodfiles Ltd; 🇫🇮 Kuopio, Finland