Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension

Study Overview
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Brief Summary
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This clinical trial is being conducted to study the effect of whole hemp seed protein, hemp seed protein hydrolysate derived bioactive peptide and casein protein consumption on systolic and diastolic ambulatory blood pressure. This study is will be conducted in 35 hypertensive participants aged between ≥18 and ≤75 yrs who have systolic blood pressure higher than 130 mmHg or diastolic blood pressure ≤ 110 mmHg. The study will consist of 3 periods of 42 days each during which participants will consume assigned treatment. Consumption of treatments will be from days 1 to 42. There will also be a washout period of a minimum of 14 days between the 3 treatment periods where the participants can consume their habitual diets. The entire study is designed to take 22 weeks from start to completion. The participants will consume the assigned treatment twice a day. The treatments are in the form of a smoothie and the smoothies will consist of frozen fruit, fruit juice, frozen yoghurt/sorbet, and 25 g of protein from treatment protein powder which is 25 grams of casein protein, 25 grams of hemp seed protein, or 22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides. On days 1 and 42 of each treatment period of the trial, body weight, waist and hip circumference, blood pressure, pulse wave velocity (PWV) and augmentation index (AI) will be measured. Ambulatory blood pressure (ABP) over 24 hours will also be measured on day 1 of phase 1 and day 42 of each treatment period of the trial.

Official Title
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Double-blind, Randomized, Cross-over Trial of Whole Hemp Seed Protein and Hemp Seed Protein Hydrolysate Derived Bioactive Peptide Consumption for Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Other: Whole hemp seed protein
* Other: Whole hemp seed protein plus bioactive peptides
* Other: Casein protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 18.5-40 kg/m2 Systolic blood pressure between 130-160 mmHg Diastolic blood pressure ≤ 110 mmHg Ability and willingness to give informed consent to participate in the trial Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits Willingness to fast 10-12 hours before blood samples and abstain from alcohol two days prior to blood sampling and BP measurement and abstain from coffee and physical exercise at least 14 and 4 hours before measurement respectively Negative pregnancy test for women with child-bearing potential Exclusion Criteria: Unable to speak/read in English Active cardiovascular disease including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attacks, secondary hypertension, type 1 or type 2 diabetes, anemia, abnormal electrolytes, proteinuria, and abnormal liver, kidney or thyroid function History of cancer or malignancy in the last 5 years, or any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which could interfere with the results of the study or the safety of the participant Taking lipid or blood pressure lowering medications or any type of supplements for less than 3 months (Note: all medications or supplements will be permitted if they are on a stable dose for more than 3 months before the start of the study) Smokers, tobacco/snuff/nicotine users, recreational drug users Consuming more than 14 alcoholic beverages a week Any dietary restrictions preventing from consuming the trial treatments Weight gain or loss greater than 5 kg in the past three months Exercising > 15 miles/wk or 4,000 kcal/wk Known to be pregnant or breast-feeding or planning on becoming pregnant during the trial period Having clinically significant biochemistry defined as: Sodium: <134 mmol/l, >148 mmol/l; fasting glucose: > 6.1 mmol/L; LDL-C ≥4.9 mmol/L or any other clinically significant abnormality in hematology and/or biochemistry at the investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole hemp seed protein<br>25 grams of hemp seed protein powder, twice a day | Other: Whole hemp seed protein<br>* The intervention was provided in the form of a smoothie.<br>|
| Experimental: Whole hemp seed protein plus bioactive peptides<br>22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day | Other: Whole hemp seed protein plus bioactive peptides<br>* The intervention was provided in the form of a smoothie.<br>|
| Active Comparator: Casein protein<br>25 grams of protein powder, twice a day | Other: Casein protein<br>* The intervention was provided in the form of a smoothie.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24 hour ambulatory blood pressure | Participants were fitted with an ambulatory blood pressure monitor (ABPM) for 24 hours. Continuous diastolic and systolic blood pressure were measured over 24 hours. | Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum renin | Measured using a fluorometric microplate reader (Spectra MAX Gemini, Molecular Devices, Sunnyvale, CA). | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum renin at day 42 of phase 1, 2 and 3 | 
| Change in angiotensin-converting enzyme (ACE) activity in the plasma | Measured using spectrophotometric method with furanacryloyl-L-phenylalanylglycylglycine (FAPGG) as substrate | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma ACE activity at day 42 of phase 1, 2 and 3 | 
| Change in nitric oxide (NO) plasma concentrations | Was determined in plasma using nitrate/nitrite colorimetric assay kit (Cayman Chemical, Michigan, USA) | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma NO concentration at day 42 of phase 1, 2 and 3 | 
| Change in plasma reactive oxygen and nitrogen species (ROS/RNS) | Was determined using OxiSelec ROS/RNS assay kit and fluorescence plate reader at 480 nm excitation / 530 nm emission | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline ROS/RNS concentration at day 42 of phase 1, 2 and 3 | 
| Change in plasma total peroxides (PTPs) | Was determined using microplate reader at 500 nm | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline PTPs concentration at day 42 of phase 1, 2 and 3 | 
| Change in plasma superoxide dismutase (SOD) | SOD OxiSelect assay kit (Cell Biolabs, Inc., San Diego, CA, USA) and microplate reader at 490 nm were used for this assay | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma SOD concentration at day 42 of phase 1, 2 and 3 | 
| Change in plasma catalase (CAT) | CAT assay kit (Cell Biolabs, Inc. San Diego, CA, USA) and fluorescence microplate reader at excitation and emission 550 and 590 nm were used for this assay | Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma CAT concentration at day 42 of phase 1, 2 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemp seed protein, Protein hydrolysate, Bioactive peptides, Cannabis sativa, High blood pressure