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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:30 - 75
Updated:4/21/2016
Start Date:November 2013
End Date:November 2015

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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

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.


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
We found this trial at
2
sites
Addison, Illinois 60101
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Addison, IL
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Corunna,
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