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Completed

NCT Number: NCT01583582

Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oy Foodfiles Ltd

Kuopio, 70210, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marealis refined peptide concentrate

Dietary Supplement

1200 mg per os, once a day, 8 weeks

Primary outcomes

  1. change in systolic blood pressure

    Time frame: from baseline after 8 weeks of treatment

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

Secondary outcomes

  1. change in diastolic blood pressure

    Time frame: from baseline after 8 weeks of treatment

    change from baseline after 8 weeks of treatment in diastolic blood pressure

  2. mean systolic blood pressure

    Time frame: at the end of a 8-week treatment

  3. mean diastolic blood pressure

    Time frame: at the end of a 8-week treatment

  4. change in systolic blood pressure

    Time frame: from baseline after 4 weeks treatment

  5. diastolic blood pressure

    Time frame: from baseline after 4 weeks treatment

  6. diastolic blood pressure

    Time frame: from baseline after 2 weeks treatment

  7. mean heart rate

    Time frame: at the end of a 8-week treatment

  8. mean fasting plasma glucose concentration

    Time frame: at the end of a 8-week treatment

  9. mean fasting plasma lipids concentration

    Time frame: at the end of a 8 week treatment

    plasma total cholesterol, HDL-cholesterol, LDL-cholesterol and total triglycerides concentration, respectively

  10. mean serum C-reactive protein

    Time frame: at the end of a 8-week treatment

  11. blood count

    Time frame: at the end of a 8-week treatment

  12. plasma glutamyltransferase

    Time frame: at the end of a 8-week treatment

  13. plasma creatinine

    Time frame: at the end of a 8-week treatment

  14. plasma sodium concentration

    Time frame: at the end of a 8-week treatment

  15. plasma potassium concentration

    Time frame: at the end of a 8-week treatment

  16. adverse events

    Time frame: during the 8-week treatment

  17. change in systolic blood pressure

    Time frame: from the baseline after 2 weeks treatment

Sponsors and collaborators

Lead sponsor

Marealis AS

Industry

Registry information

Official study title

Assessment on Antihypertensive Effect and Safety of Bioactive Peptides Derived From Coldwater Shrimp (Pandalus Borealis) in Healthy Subjects With Mild or Moderate Hypertension

Acronym: MARE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2012
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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