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

NCT ID: NCT01974570

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-11-30

Brief Summary

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.

Conditions

Prehypertension

Keywords

Prehypertension; Hypertension; Shrimp protein hydrolysate; Marine protein hydrolysate; Ambulatory blood pressure; Blood pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Marealis refined peptide concentrate

Participants are provided in double blinded fashion to Marealis refined peptide concentrate

Group Type: EXPERIMENTAL

Marealis refined peptide concentrate

Intervention Type: DIETARY_SUPPLEMENT

2 tablets, once per day before noon

Placebo

Participants are provided in double blinded fashion to Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2 tablets, once per day before noon

Interventions

Marealis refined peptide concentrate

2 tablets, once per day before noon

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2 tablets, once per day before noon

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marealis AS

INDUSTRY

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dale Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

Biofortis Inc.

Addison, Illinois, United States

Dr. William O'Mahony Medicine Professional Corporation

Corunna, Ontario, Canada

Dr. Steven V. Zizzo Medicine Professional Corporation

Hamilton, Ontario, Canada

Milestone Research

London, Ontario, Canada

Schacter Medicine Professional Corporation

London, Ontario, Canada

KGK Synergize Inc.

London, Ontario, Canada

Dr. Dorli Herman

London, Ontario, Canada

SKDS Research Inc.

Newmarket, Ontario, Canada

Glencar Medical Inc.

Sarnia, Ontario, Canada

Dr. Anil Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

Devonshire Clinical Research

Woodstock, Ontario, Canada

A-Pharma, s.r.o

Prague, , Czechia

Analyze and Realize GmBH Professional Group

Berlin, , Germany

Countries

United States; Canada; Czechia; Germany

References

Musa-Veloso K, Paulionis L, Pelipyagina T, Evans M. A Randomized, Double-Blind, Placebo-Controlled, Multicentre Trial of the Effects of a Shrimp Protein Hydrolysate on Blood Pressure. Int J Hypertens. 2019 Aug 5;2019:2345042. doi: 10.1155/2019/2345042. eCollection 2019.

Reference Type: DERIVED

PMID: 31467699 (View on PubMed)

Other Identifiers

13TBHM

Identifier Type: -

Identifier Source: org_study_id