Clinical trial NCT03508895: Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension
Official title: Double-blind, Randomized, Cross-over Trial of Whole Hemp Seed Protein and Hemp Seed Protein Hydrolysate Derived Bioactive Peptide Consumption for Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hemp seed protein
Protein hydrolysate
Bioactive peptides
Cannabis sativa
High blood pressure
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: Manitoba Harvest
First posted: 2018-04-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 24 hour ambulatory blood pressure
timeFrame: Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3
Secondary outcomes:
measure: Change in serum renin concentration
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum renin concentration at day 42 of phase 1, 2 and 3
measure: Change in angiotensin-converting enzyme (ACE) activity in the plasma
timeFrame: 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
measure: Change in nitric oxide (NO) plasma concentrations
timeFrame: 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
measure: Change in plasma reactive oxygen and nitrogen species (ROS/RNS) concentration
timeFrame: 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
measure: Change in plasma total peroxides (PTPs) concentration
timeFrame: 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
measure: Change in plasma superoxide dismutase (SOD) concentration
timeFrame: 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
measure: Change in plasma catalase (CAT) concentration
timeFrame: 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
measure: Change in plasma free oxylipin concentrations
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma free oxylipin concentrations at day 42 of phase 1, 2 and 3
Other outcomes:
measure: Change in blood pressure
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline blood pressure at week 3 and 6 of phase 1, 2 and 3
measure: Change in pulse wave velocity (PWV)
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline PWV at week 6 of phase 1, 2 and 3
measure: Change in augmentation index (AI)
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline AI at week 6 of phase 1, 2 and 3
measure: Change in body weight
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline body weight at week 6 of phase 1, 2 and 3
measure: Change in waist circumference
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline waist circumference at week 6 of phase 1, 2 and 3
measure: Change in hip circumference
timeFrame: Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline hip circumference at week 6 of phase 1, 2 and 3
measure: Change in body composition
timeFrame: Measured at day 1 of phase 1 (baseline) and change from baseline body composition at week 6 of phase 1, 2 and 3
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Food Technology and Research
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rotimi Aluko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samsamikor M, Mackay D, Mollard RC, Aluko RE. A double-blind, randomized, crossover trial protocol of whole hemp seed protein and hemp seed protein hydrolysate consumption for hypertension. Trials. 2020 Apr 23;21(1):354. doi: 10.1186/s13063-020-4164-z.