Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp

Hypertension Clinical Trial

— MARE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583582
• Other study ID #: MARE-050312
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2012
• Last updated: January 30, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Marealis AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• Marealis Refined Peptide Concentrate
1200 mg per os, once a day, 8 weeks
• Marealis Refined Peptide Concentrate
600 mg per os, twice a day, 8 weeks
• Marealis Refined Peptide Concentrate
0 mg per os, daily, 8 weeks

Locations

Country	Name	City	State
Finland	Oy Foodfiles Ltd	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Marealis AS

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in diastolic blood pressure	change from baseline after 8 weeks of treatment in diastolic blood pressure	from baseline after 8 weeks of treatment	No
Secondary	mean systolic blood pressure		at the end of a 8-week treatment	No
Secondary	mean diastolic blood pressure		at the end of a 8-week treatment	No
Secondary	change in systolic blood pressure		from baseline after 4 weeks treatment	No
Secondary	diastolic blood pressure		from baseline after 4 weeks treatment	No
Secondary	diastolic blood pressure		from baseline after 2 weeks treatment	No
Secondary	mean heart rate		at the end of a 8-week treatment	No
Secondary	mean fasting plasma glucose concentration		at the end of a 8-week treatment	No
Secondary	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	No
Secondary	mean serum C-reactive protein		at the end of a 8-week treatment	No
Secondary	blood count		at the end of a 8-week treatment	Yes
Secondary	plasma glutamyltransferase		at the end of a 8-week treatment	Yes
Secondary	plasma creatinine		at the end of a 8-week treatment	Yes
Secondary	plasma sodium concentration		at the end of a 8-week treatment	Yes
Secondary	plasma potassium concentration		at the end of a 8-week treatment	Yes
Secondary	adverse events		during the 8-week treatment	Yes
Secondary	change in systolic blood pressure		from the baseline after 2 weeks treatment	No