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

KGK Science

Status and phase

Completed

Phase 2

Conditions

Prehypertension

Treatments

Dietary Supplement: Marealis refined peptide concentrate

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01974570

13TBHM

Details and patient eligibility

About

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.

Enrollment

144 patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

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