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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
History of Changes
  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:

U.S. FDA Resources

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 May 21, 2013