Abstract
BackgroundPrimary hypertension accounts for almost 95% of all cases of high blood pressure and is a major modifiable risk factor for cardiovascular diseases. Lifestyle interventions have been shown to prevent hypertension. One of the prominent potential therapeutic lifestyle strategies to prevent or manage hypertension is increasing dietary protein as a macronutrient or as bioactive peptides. An emerging plant-based protein source that may have anti-hypertensive properties is hemp seed.Methods/designA randomized, double-blind, crossover clinical trial will be conducted on 35 hypertensive participants aged 18–75 years, with a BMI between 18.5 and 40 kg/m2, systolic blood pressure (SBP) between 130 and 160 mmHg and diastolic blood pressure (DBP) ≤ 110 mmHg. The trial will be conducted for a period of 22 weeks and will consist of three treatment periods of 6 weeks, separated by 2-week washout periods. The treatments will be consumed twice a day and consist of 25 g casein, hemp seed protein (HSP), or HSP plus HSP hydrolysate (HSP+). The primary outcome of this trial is 24-h SBP, measured on the first day of first phase and the last day of each phase. Office-measured blood pressure, pulse-wave velocity and augmentation index and anthropometrics will be determined at the first and last days of each period. Also, body composition will be assessed by dual x-ray absorptiometry (DXA) scan on the first day of the first phase and within the last 2 days of each treatment period. Blood samples will be collected on the first and last 2 days of each treatment phase whereas urine samples will be collected on the first day of the first phase plus the last day of each phase to be analyzed for specific biomarkers.DiscussionThis trial protocol is designed to evaluate the hypotensive potential of consuming whole HSP, and HSP+, in comparison to casein protein. This study will be the first trial investigating the potential anti-hypertensive benefit of dietary hemp protein plus bioactive peptide consumption in humans.Trial registrationNational Clinical Trial (NCT), ID: NCT03508895. Registered on 28 June 2018. Retrospectively registered on the publicly accessible Registry Databank at ClinicalTrials.gov (http://ClinicalTrials.gov).
Highlights
Primary hypertension accounts for almost 95% of all cases of high blood pressure and is a major modifiable risk factor for cardiovascular diseases
A meta-analysis of 40 randomized controlled trials demonstrated that replacing a median of 40 g/day of dietary carbohydrate with dietary protein is associated with small reductions in both systolic − 1.76 mmHg (95% confidence interval (CI) − 2.33, − 1.20) and diastolic − 1.15 mmHg blood pressure (BP) (SBP and diastolic blood pressure (DBP), respectively) [22]
No trials investigating the potential benefit of increased dietary protein plus bioactive peptides have been completed to our knowledge. To address these knowledge gaps, we propose a clinical trial that would evaluate the anti-hypertensive potential of consuming whole hemp seed protein (HSP), and HSP+, compared to casein protein using a randomized, double-blinded and crossover design
Summary
Primary hypertension accounts for almost 95% of all cases of high blood pressure and is a major modifiable risk factor for cardiovascular diseases. Lifestyle interventions have been shown to prevent hypertension. One of the prominent potential therapeutic lifestyle strategies to prevent or manage hypertension is increasing dietary protein as a macronutrient or as bioactive peptides. Uncontrolled hypertension can lead to a spectrum of diseases including stroke, coronary artery disease, as well as heart and kidney failure [5]. The exact etiology of the development and progression of primary hypertension remains uncertain; both genetic and lifestyle factors, including diet in particular, have been implicated. Many interconnected contributing factors have been proposed to explain the increase in blood pressure (BP) leading to hypertension. An important need exists for alternative therapeutic strategies to prevent or manage hypertension
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