Clinical trial NCT01974570: Effect and Safety of Marealis RPC (Refined Peptide Concentrate) in Mild or Moderate Hypertensive Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prehypertension
Keywords: Prehypertension
Hypertension
Shrimp protein hydrolysate
Marine protein hydrolysate
Ambulatory blood pressure
Blood pressure
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Marealis AS
First posted: 2013-11-01
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in daytime ambulatory systolic blood pressure from baseline
timeFrame: 8 weeks
measure: Change in office systolic blood pressure from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline
timeFrame: 8 weeks
measure: Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline
timeFrame: 8 weeks
measure: Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline
timeFrame: 4 weeks
measure: Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime)
timeFrame: Over 8 weeks
measure: Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime)
timeFrame: Over 8 weeks
measure: Change in office diastolic blood pressure from baseline
timeFrame: 8 weeks
measure: Changes in office systolic and office diastolic blood pressure from baseline
timeFrame: 2 weeks
measure: Changes in office systolic and office diastolic blood pressure from baseline
timeFrame: 4 weeks
measure: Mean Office systolic blood pressure
timeFrame: Over 8 weeks
measure: Mean Office diastolic blood pressure
timeFrame: Over 8 weeks
Other outcomes:
measure: Mean heart rate
timeFrame: Over 8 weeks
measure: Mean fasting serum glucose
timeFrame: 8 weeks
measure: Mean fasting serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides)
timeFrame: 8 weeks
measure: Mean serum C-reactive protein
timeFrame: 8 weeks
measure: Dietary variables from food records (energy, carbohydrates, fats, proteins, fiber and sodium)
timeFrame: Over 8 weeks
measure: Mean urine sodium
timeFrame: 8 weeks
measure: Biometrics: weight and BMI
timeFrame: 8 weeks
measure: Blood safety parameters: complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT, GGT, bilirubin
timeFrame: 8 weeks
measure: Adverse events
timeFrame: Over 8 weeks
Locations:
city: Addison
country: United States
facility: Biofortis Inc.
state: Illinois
city: Corunna
country: Canada
facility: Dr. William O'Mahony Medicine Professional Corporation
state: Ontario
city: Hamilton
country: Canada
facility: Dr. Steven V. Zizzo Medicine Professional Corporation
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: London
country: Canada
facility: Schacter Medicine Professional Corporation
state: Ontario
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
city: London
country: Canada
facility: Dr. Dorli Herman
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Sarnia
country: Canada
facility: Glencar Medical Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil Gupta Medicine Professional Corporation
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research
state: Ontario
city: Praha
country: Czech Republic
facility: A-Pharma, s.r.o
city: Berlin
country: Germany
facility: Analyze and Realize GmBH Professional Group
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.