Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp (MARE)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Blood Pressure
• Intervention / Treatment: Dietary supplement: Marealis Refined Peptide Concentrate; Dietary supplement: Marealis Refined Peptide Concentrate; Dietary supplement: Marealis Refined Peptide Concentrate

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70210
    • Oy Foodfiles Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refined peptide concentrate, 1200 mg; Refined peptide concentrate, 1 200 mg, once a day	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
Experimental: Refined peptide concentrate, 2 x 600 mg; Refined peptide concentrate, 600 mg, twice a day	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
Placebo Comparator: Refined peptide concentrate, 0 mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in systolic blood pressure	change from baseline after 8 weeks of treatment in systolic office blood pressure	from baseline after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in diastolic blood pressure	change from baseline after 8 weeks of treatment in diastolic blood pressure	from baseline after 8 weeks of treatment
mean systolic blood pressure		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 baseline after 4 weeks treatment
diastolic blood pressure		from baseline after 4 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	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		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
change in systolic blood pressure		from the baseline after 2 weeks treatment

Collaborators and Investigators

• Sponsor: Marealis AS
• Investigators: Study Director: Essi S Sarkkinen, Ph.D, Oy Foodfiles Ltd; Principal Investigator: Sakari A Nieminen, MD, Oy Foodfiles Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: April 20, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: blood pressure; randomized double-blind placebo-controlled study; peptide concentrate; Coldwater Shrimp; antihypertensive effect; mild hypertension; moderate hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: MARE-050312