Abstract

In this randomized, double-blind, placebo-controlled, multicentre, parallel, 8-week study, the efficacy of a daily dose of 1200 mg of protein hydrolysate from Coldwater Shrimp (Pandalus borealis) on ambulatory and office blood pressure was investigated in 144 free-living adults with mild to moderate hypertension. The primary outcomes of the study were daytime ambulatory systolic blood pressure and office blood pressure. During the 8-week intervention period and in the intention-to-treat analysis (n=144), there were significant reductions in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group in daytime ambulatory systolic blood pressure at 4 weeks (p=0.014) and at 8 weeks (p=0.002), and in office systolic blood pressure at 2 weeks (p=0.031) and 4 weeks (p=0.010), with a trend toward significance at 8 weeks (p=0.087). By 8 weeks, significant and favourable improvements in the group consuming the shrimp-derived protein hydrolysate relative to the placebo group were also observed for several secondary outcomes, including 24-hour ambulatory systolic and diastolic blood pressure, daytime ambulatory diastolic blood pressure, and daytime and 24-hour ambulatory mean arterial pressure. Also by Week 8, there was a statistically significant difference between groups in the distribution of subjects across National Institutes of Health-defined blood pressure categories (i.e., Normotensive, Prehypertensive, Stage 1 hypertension, and Stage 2 hypertension), with a more favourable distribution in the shrimp-derived protein hydrolysate group than in the placebo group (p=0.006). Based on exploratory analyses conducted only in participants in the shrimp-derived protein hydrolysate group, angiotensin II levels were significantly reduced relative to baseline. This study is registered at ClinicalTrials.gov NCT01974570.

Highlights

  • According to 2008 data collected by the World Health Organization (WHO) on noncommunicable diseases, globally, the overall prevalence of elevated blood pressure (BP) in adults 25 years of age and older is 40% [1, 2]

  • We report the results of a randomized, double-blind, placebo-controlled, multicentre, parallel study in which the primary objectives were to assess the efficacy of desalted shrimp protein hydrolysate from Coldwater Shrimp (Pandalus borealis) on the changes from baseline in daytime ambulatory SBP and office SBP in individuals with mild to moderate hypertension

  • These subjects were excluded from the PP population which, as a result, consisted of 125 subjects (62 in the placebo group and 63 in the Refined Peptide Concentrate (RPC) group)

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Summary

Introduction

According to 2008 data collected by the World Health Organization (WHO) on noncommunicable diseases, globally, the overall prevalence of elevated blood pressure (BP) (defined as a systolic blood pressure [SBP] ≥140 mmHg or a diastolic blood pressure [DBP] ≥90 mmHg) in adults 25 years of age and older is 40% [1, 2]. As a global target to be achieved by 2025, the WHO has called for a 25% relative reduction in the prevalence of raised BP or the containment of the prevalence of raised BP, according to national circumstances [5]. With the worldwide surge in the aging population, the prevalence of elevated BP is steadily increasing, and additional interventions that could assist with the maintenance of normal BP levels are needed

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