CompletedPhase 2

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

United States, Canada144 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Antihypertens…

What they're measuring

Change in daytime ambulatory systolic blood pressure from baseline

Timeframe: 8 weeks

Change in office systolic blood pressure from baseline

Timeframe: 8 weeks

Trial details

NCT IDNCT01974570

SponsorKGK Science Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-11