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

Prehypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974570
• Other study ID #: 13TBHM
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2013
• Last updated: December 23, 2015
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prehypertension

Intervention

Dietary Supplement:
• Marealis refined peptide concentrate
2 tablets, once per day before noon
• Placebo
2 tablets, once per day before noon

Locations

Country	Name	City	State
Canada	Dr. William O'Mahony Medicine Professional Corporation	Corunna	Ontario
Canada	Dr. Steven V. Zizzo Medicine Professional Corporation	Hamilton	Ontario
Canada	Dr. Dorli Herman	London	Ontario
Canada	KGK Synergize Inc.	London	Ontario
Canada	Milestone Research	London	Ontario
Canada	Schacter Medicine Professional Corporation	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
Czech Republic	A-Pharma, s.r.o	Praha
Germany	Analyze and Realize GmBH Professional Group	Berlin
United States	Biofortis Inc.	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Marealis AS

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean heart rate		Over 8 weeks	No
Other	Mean fasting serum glucose		8 weeks	No
Other	Mean fasting serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides)		8 weeks	No
Other	Mean serum C-reactive protein		8 weeks	No
Other	Dietary variables from food records (energy, carbohydrates, fats, proteins, fiber and sodium)		Over 8 weeks	No
Other	Mean urine sodium		8 weeks	No
Other	Biometrics: weight and BMI		8 weeks	Yes
Other	Blood safety parameters: complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT, GGT, bilirubin		8 weeks	Yes
Other	Adverse events		Over 8 weeks	Yes
Primary	Change in daytime ambulatory systolic blood pressure from baseline		8 weeks	No
Primary	Change in office systolic blood pressure from baseline		8 weeks	No
Secondary	Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline		8 weeks	No
Secondary	Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline		8 weeks	No
Secondary	Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline		4 weeks	No
Secondary	Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime)		Over 8 weeks	No
Secondary	Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime)		Over 8 weeks	No
Secondary	Change in office diastolic blood pressure from baseline		8 weeks	No
Secondary	Changes in office systolic and office diastolic blood pressure from baseline		2 weeks	No
Secondary	Changes in office systolic and office diastolic blood pressure from baseline		4 weeks	No
Secondary	Mean Office systolic blood pressure		Over 8 weeks	No
Secondary	Mean Office diastolic blood pressure		Over 8 weeks	No