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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Niina Tapola, Marealis AS
ClinicalTrials.gov Identifier:
NCT01583582
First received: April 20, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Blood Pressure
Dietary Supplement: Marealis Refined Peptide Concentrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension

Resource links provided by NLM:


Further study details as provided by Marealis AS:

Primary Outcome Measures:
  • change in systolic blood pressure [ Time Frame: from baseline after 8 weeks of treatment ] [ Designated as safety issue: No ]
    change from baseline after 8 weeks of treatment in systolic office blood pressure


Secondary Outcome Measures:
  • change in diastolic blood pressure [ Time Frame: from baseline after 8 weeks of treatment ] [ Designated as safety issue: No ]
    change from baseline after 8 weeks of treatment in diastolic blood pressure

  • mean systolic blood pressure [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: No ]
  • mean diastolic blood pressure [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: No ]
  • change in systolic blood pressure [ Time Frame: from baseline after 4 weeks treatment ] [ Designated as safety issue: No ]
  • diastolic blood pressure [ Time Frame: from baseline after 4 weeks treatment ] [ Designated as safety issue: No ]
  • diastolic blood pressure [ Time Frame: from baseline after 2 weeks treatment ] [ Designated as safety issue: No ]
  • mean heart rate [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: No ]
  • mean fasting plasma glucose concentration [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: No ]
  • mean fasting plasma lipids concentration [ Time Frame: at the end of a 8 week treatment ] [ Designated as safety issue: No ]
    plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively

  • mean serum C-reactive protein [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: No ]
  • blood count [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: Yes ]
  • plasma glutamyltransferase [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: Yes ]
  • plasma creatinine [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: Yes ]
  • plasma sodium concentration [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: Yes ]
  • plasma potassium concentration [ Time Frame: at the end of a 8-week treatment ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: during the 8-week treatment ] [ Designated as safety issue: Yes ]
  • change in systolic blood pressure [ Time Frame: from the baseline after 2 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Refined peptide concentrate, 2 x 600 mg
Refined peptide concentrate, 600 mg, twice a day
Dietary Supplement: Marealis Refined Peptide Concentrate
600 mg per os, twice a day, 8 weeks
Placebo Comparator: Refined peptide concentrate, 0 mg Dietary Supplement: Marealis Refined Peptide Concentrate
0 mg per os, daily, 8 weeks

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583582

Locations
Finland
Oy Foodfiles Ltd
Kuopio, Finland, 70210
Sponsors and Collaborators
Marealis AS
Investigators
Study Director: Essi S Sarkkinen, Ph.D Oy Foodfiles Ltd
Principal Investigator: Sakari A Nieminen, MD Oy Foodfiles Ltd
  More Information

No publications provided

Responsible Party: Niina Tapola, Project Manager, Marealis AS
ClinicalTrials.gov Identifier: NCT01583582     History of Changes
Other Study ID Numbers: MARE-050312
Study First Received: April 20, 2012
Last Updated: January 30, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Marealis AS:
randomized double-blind placebo-controlled study
peptide concentrate
Coldwater Shrimp
antihypertensive effect
mild hypertension
moderate hypertension
blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014