Trial record 6 of 22 for:    Open Studies | "Prehypertension"

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

This study is currently recruiting participants.
Verified February 2014 by KGK Synergize Inc.
Sponsor:
Collaborator:
Marealis AS
Information provided by (Responsible Party):
KGK Synergize Inc.
ClinicalTrials.gov Identifier:
NCT01974570
First received: October 28, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Prehypertension
Dietary Supplement: Marealis refined peptide concentrate
Dietary Supplement: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by KGK Synergize Inc.:

Primary Outcome Measures:
  • Change in daytime ambulatory systolic blood pressure from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in office systolic blood pressure from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime) [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]
  • Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime) [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]
  • Change in office diastolic blood pressure from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes in office systolic and office diastolic blood pressure from baseline [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes in office systolic and office diastolic blood pressure from baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Mean Office systolic blood pressure [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]
  • Mean Office diastolic blood pressure [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Mean heart rate [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]
  • Mean fasting serum glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean fasting serum lipids (total cholesterol, HDL-cholesterol, LDL-cholesterol, total triglycerides) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Mean serum C-reactive protein [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Dietary variables from food records (energy, carbohydrates, fats, proteins, fiber and sodium) [ Time Frame: Over 8 weeks ] [ Designated as safety issue: No ]
  • Mean urine sodium [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Biometrics: weight and BMI [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Blood safety parameters: complete blood count, electrolytes (Na, K, Cl), creatinine, eGFR, AST, ALT, GGT, bilirubin [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Over 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: November 2013
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Marealis refined peptide concentrate
Participants are provided in double blinded fashion to Marealis refined peptide concentrate
Dietary Supplement: Marealis refined peptide concentrate
2 tablets, once per day before noon
Placebo Comparator: Placebo
Participants are provided in double blinded fashion to Placebo
Dietary Supplement: Placebo
2 tablets, once per day before noon

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01974570

Contacts
Contact: Mal Evans, PhD 519-438-9374 ext 239 mevans@kgksynergize.com

Locations
United States, Illinois
Biofortis Inc. Recruiting
Addison, Illinois, United States, 60101
Contact    630-617-2000      
Principal Investigator: Kathleen Kelley, MD         
Canada, Ontario
KGK Synergize Inc. Recruiting
London, Ontario, Canada, N6A 5R8
Contact: Mal Evans, PhD    (519) 438-9374 ext 239    mevans@kgksynergize.com   
Principal Investigator: Dale Wilson, MD         
Sponsors and Collaborators
KGK Synergize Inc.
Marealis AS
Investigators
Principal Investigator: Dale Wilson, MD KGK Synergize Inc.
  More Information

No publications provided

Responsible Party: KGK Synergize Inc.
ClinicalTrials.gov Identifier: NCT01974570     History of Changes
Other Study ID Numbers: 13TBHM
Study First Received: October 28, 2013
Last Updated: February 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by KGK Synergize Inc.:
Prehypertension
Hypertension
Shrimp protein hydrolysate
Marine protein hydrolysate
Ambulatory blood pressure
Blood pressure

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014