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

KGK Science Inc.13 sites in 4 countries144 target enrollmentNovember 2013

ConditionsPrehypertension

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prehypertension
Sponsor: KGK Science Inc.
Enrollment: 144
Locations: 13
Primary Endpoint: Change in daytime ambulatory systolic blood pressure from baseline
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KGK Science Inc.

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

Change in daytime ambulatory systolic blood pressure from baseline

Time Frame: 8 weeks

Change in office systolic blood pressure from baseline

Time Frame: 8 weeks

Secondary Outcomes

Mean ambulatory diastolic blood pressure (24-hour, daytime and nighttime)(Over 8 weeks)
Change in 24-hour, daytime and nighttime ambulatory diastolic blood pressure from baseline(8 weeks)
Changes in office systolic and office diastolic blood pressure from baseline(4 weeks)
Change in 24-hour and nighttime ambulatory systolic blood pressure from baseline(8 weeks)
Mean ambulatory systolic blood pressure (24-hour, daytime and nighttime)(Over 8 weeks)
Mean Office systolic blood pressure(Over 8 weeks)
Mean Office diastolic blood pressure(Over 8 weeks)
Changes in 24-hour, daytime and nighttime ambulatory systolic and ambulatory diastolic blood pressure from baseline(4 weeks)
Change in office diastolic blood pressure from baseline(8 weeks)