Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Blood Pressure

Intervention / Treatment
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* Dietary Supplement: Marealis Refined Peptide Concentrate
* Dietary Supplement: Marealis Refined Peptide Concentrate
* Dietary Supplement: Marealis Refined Peptide Concentrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Refined peptide concentrate, 1200 mg<br>Refined peptide concentrate, 1 200 mg, once a day | Dietary Supplement: Marealis Refined Peptide Concentrate<br>* 1200 mg per os, once a day, 8 weeks<br>|
| Experimental: Refined peptide concentrate, 2 x 600 mg<br>Refined peptide concentrate, 600 mg, twice a day | Dietary Supplement: Marealis Refined Peptide Concentrate<br>* 600 mg per os, twice a day, 8 weeks<br>|
| Placebo Comparator: Refined peptide concentrate, 0 mg<br> | Dietary Supplement: Marealis Refined Peptide Concentrate<br>* 0 mg per os, daily, 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in diastolic blood pressure | change from baseline after 8 weeks of treatment in diastolic blood pressure | from baseline after 8 weeks of treatment | 
| mean systolic blood pressure |  | at the end of a 8-week treatment | 
| mean diastolic blood pressure |  | at the end of a 8-week treatment | 
| change in systolic blood pressure |  | from baseline after 4 weeks treatment | 
| diastolic blood pressure |  | from baseline after 4 weeks treatment | 
| diastolic blood pressure |  | from baseline after 2 weeks treatment | 
| mean heart rate |  | at the end of a 8-week treatment | 
| mean fasting plasma glucose concentration |  | at the end of a 8-week treatment | 
| 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 | 
| mean serum C-reactive protein |  | at the end of a 8-week treatment | 
| blood count |  | at the end of a 8-week treatment | 
| plasma glutamyltransferase |  | at the end of a 8-week treatment | 
| plasma creatinine |  | at the end of a 8-week treatment | 
| plasma sodium concentration |  | at the end of a 8-week treatment | 
| plasma potassium concentration |  | at the end of a 8-week treatment | 
| adverse events |  | during the 8-week treatment | 
| change in systolic blood pressure |  | from the baseline after 2 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized double-blind placebo-controlled study, peptide concentrate, Coldwater Shrimp, antihypertensive effect, mild hypertension, moderate hypertension, blood pressure