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

NCT01974570 | Completed Phase 2

• 1 other identifier: 13TBHM
• Study Type: interventional
• Target: 144
• Locations: 4 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (2)

• Change in daytime ambulatory systolic blood pressure from baseline

  8 weeks

• Change in office systolic blood pressure from baseline

  8 weeks

Secondary Outcomes (10)

• 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

Other Outcomes (9)

• Mean heart rate

  Over 8 weeks

• Mean fasting serum glucose

  8 weeks

• Mean fasting serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides)

  8 weeks

Study Arms (2)

Marealis refined peptide concentrate

EXPERIMENTAL

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

Dietary Supplement: Marealis refined peptide concentrate

Placebo

PLACEBO COMPARATOR

Participants are provided in double blinded fashion to Placebo

Dietary Supplement: Placebo

Interventions

Marealis refined peptide concentrate DIETARY_SUPPLEMENT

2 tablets, once per day before noon

Marealis refined peptide concentrate

Placebo DIETARY_SUPPLEMENT

2 tablets, once per day before noon

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• Marealis AS: collaborator

Study Sites (13)

Biofortis Inc.

Addison, Illinois, 60101, United States

Location

Dr. William O'Mahony Medicine Professional Corporation

Corunna, Ontario, N0N 1G0, Canada

Location

Dr. Steven V. Zizzo Medicine Professional Corporation

Hamilton, Ontario, L8J 0B6, Canada

Location

Milestone Research

London, Ontario, N5W 6A2, Canada

Location

Schacter Medicine Professional Corporation

London, Ontario, N5Y 5K7, Canada

Location

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Dr. Dorli Herman

London, Ontario, N6J 0A8, Canada

Location

SKDS Research Inc.

Newmarket, Ontario, L3Y 5G8, Canada

Location

Glencar Medical Inc.

Sarnia, Ontario, N7T 4X3, Canada

Location

Dr. Anil Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Devonshire Clinical Research

Woodstock, Ontario, N4S 5P5, Canada

Location

A-Pharma, s.r.o

Prague, Czechia

Location

Analyze and Realize GmBH Professional Group

Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 31467699 DERIVED

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dale Wilson, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 1, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

CA (10); CZ (1); US (1); DE (1)