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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01974570
Other study ID # 13TBHM
Secondary ID
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


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
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