Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects

Study Overview
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Brief Summary
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Hypertension is an important risk factor of cardiovascular (CVD) and renal diseases. Epidemiological studies show that there is a direct relationship between blood pressure and CVD, and cardiovascular mortality increases progressively throughout the range of blood pressure, including the prehypertensive range. There is also evidence from cell and animal studies that shrimp tissue hydrolysates may have higher ACE inhibitory activity than other marine protein hydrolysates. It is hypothesized that Marealis RPC (refined peptide concentrate)will lower systolic blood pressure in subjects with elevated blood pressure.

Official Title
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A Randomized, Double-blind, Placebo Controlled, Parallel Study for the Assessment of Anti-hypertensive Effect and Safety of Marealis RPC (Refined Peptide Concentrate), in Healthy Subjects With Mild or Moderate Hypertension

Conditions
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Prehypertension

Intervention / Treatment
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* Dietary Supplement: Marealis refined peptide concentrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 30 to 75 years inclusive (independent and home-living subject). If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation); OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Mild or moderate hypertension (SBP 140-160 mmHg and DBP ≤ 100mmHg) (mean of office blood pressure measurements at the two first study visits during run-in period (visits 1 (-4 week) and 2 (-2 week)). Average office SBP baseline to be as close to 150mm Hg (i.e. 147-149 mmHg) as possible. Body weight ≥60kg Stable body weight (self-reported weight gain or loss <5kg in the past three months) Has given voluntary, written, informed consent to participate in the study Agrees to comply with study procedures including willingness to fast at least 12 hours before blood samples and abstain from alcohol two days prior to blood sampling and blood pressure measurement and abstain from coffee at least 14 hours before blood pressure measurement and abstain from physical exercise at least 4 hours before blood pressure measurement Exclusion Criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial Body mass index ≥ 35 kg/m2 Antihypertensive drug treatment, regular high dose NSAID treatment, use of cyclosporine or tacrolimus Any history of cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack) including stroke and congestive heart failure Dementia, hypertensive retinopathy, left ventricular dysfunction or peripheral artery disease Anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function (except subjects on thyroid replacement therapy) Clinically significant laboratory results Any other clinically significant abnormality in hematology and/or biochemistry at the Investigator's discretion Secondary hypertension Diabetes (type 1 and type 2 diabetes) History of cancer or malignant disease within the past 5 years(excluding basal cell carcinoma) 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 subject Dietary restriction (fish and other seafood allergies, citrus allergies, multiple food allergies) Alcohol abuse and/or illicit drug consumption; subjects consuming more than 14 portions of alcohol per week (one portion = 1 oz. spirits or 4 oz. wine or 11oz. medium strength beer / cider) Smokers and tobacco/snuff/nicotine users Consumption of natural health products targeted to blood pressure lowering within 30 days before randomization and during the study Participation in a clinical research trial within 30 days prior to randomization or during the study Individuals who are cognitively impaired and/or who are unable to give informed consent Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Marealis refined peptide concentrate<br>Participants are provided in double blinded fashion to Marealis refined peptide concentrate | Dietary Supplement: Marealis refined peptide concentrate<br>* 2 tablets, once per day before noon<br>|
| Placebo Comparator: Placebo<br>Participants are provided in double blinded fashion to Placebo | Dietary Supplement: Placebo<br>* 2 tablets, once per day before noon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daytime ambulatory systolic blood pressure from baseline |  | 8 weeks | 
| Change in office systolic blood pressure from baseline |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline |  | 8 weeks | 
| Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline |  | 8 weeks | 
| Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline |  | 4 weeks | 
| Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime) |  | Over 8 weeks | 
| Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime) |  | Over 8 weeks | 
| Change in office diastolic blood pressure from baseline |  | 8 weeks | 
| Changes in office systolic and office diastolic blood pressure from baseline |  | 2 weeks | 
| Changes in office systolic and office diastolic blood pressure from baseline |  | 4 weeks | 
| Mean Office systolic blood pressure |  | Over 8 weeks | 
| Mean Office diastolic blood pressure |  | Over 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehypertension, Hypertension, Shrimp protein hydrolysate, Marine protein hydrolysate, Ambulatory blood pressure, Blood pressure