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

April 20, 2012
January 30, 2013
March 2012
December 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01583582 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 tretment in diastolic blood pressure
  • mean systolic blood pressure [ Time Frame: at the end of a 8-week tretament ] [ Designated as safety issue: No ]
  • mean diastolic blood pressure [ Time Frame: at the end of a 8-week tretament ] [ 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 tretament ] [ 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 concentaration, respectively
  • maean serum C-rective 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 ]
  • palsma 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 ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Blood Pressure
  • 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, 1200 mg
    Refined peptide concentrate, 1 200 mg, once a day
    Intervention: Dietary Supplement: Marealis Refined Peptide Concentrate
  • Experimental: Refined peptide concentrate, 2 x 600 mg
    Refined peptide concentrate, 600 mg, twice a day
    Intervention: Dietary Supplement: Marealis Refined Peptide Concentrate
  • Placebo Comparator: Refined peptide concentrate, 0 mg
    Intervention: Dietary Supplement: Marealis Refined Peptide Concentrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01583582
MARE-050312
No
Niina Tapola, Marealis AS
Marealis AS
Not Provided
Study Director: Essi S Sarkkinen, Ph.D Oy Foodfiles Ltd
Principal Investigator: Sakari A Nieminen, MD Oy Foodfiles Ltd
Marealis AS
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP