Double Blind, Randomized, Cross Over Trial of Whole Hemp Seed Protein and Hemp Seed Protein Hydrolysate Derived Bioactive Peptide Consumption for Hypertension

Hemp Seed Protein Consumption for Hypertension

Sponsors

Lead sponsor: University of Manitoba

Collaborator: Heart and Stroke Foundation of Canada
Manitoba Harvest

Source University of Manitoba
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.

Overall Status Recruiting
Start Date July 16, 2018
Completion Date March 2020
Primary Completion Date August 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in 24 hour ambulatory blood pressure Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3
Secondary Outcome
Measure Time Frame
Change in blood pressure 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
Change in pulse wave velocity (PWV) 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
Change in augmentation index (AI) 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
Change in body weight 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
Change in waist circumference 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
Change in hip circumference 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
Change in body composition Measured at day 1 of phase 1 (baseline) and change from baseline body composition at week 6 of phase 1, 2 and 3
Change in serum total cholesterol Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum total cholesterol at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum high-density lipoprotein cholesterol Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum high-density lipoprotein cholesterol at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum low-density lipoprotein cholesterol values Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum low-density lipoprotein cholesterol at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum triglycerides Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum triglycerides at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum glucose Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum glucose at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in fasting plasma insulin concentrations Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma insulin concentration at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in insulin homeostasis modelling assessment (HOMA) Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline insulin HOMA at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum creatinine Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum creatinine at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in blood urea nitrogen Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline blood urea nitrogen at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum aspartate aminotransferase Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum aspartate aminotransferase at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum alanine aminotransferase Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum alanine aminotransferase at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum gamma-glutamyl transferase Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum gamma-glutamyl transferase at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum total protein Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum total protein at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum albumin Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum albumin at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum angiotensin II Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum angiotensin II at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum aldosterone Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum aldosterone at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in serum renin Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum renin at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in epinephrine Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum epinephrine at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in norepinephrine Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline serum norepinephrine at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in angiotensin-converting enzyme (ACE) activity in the plasma Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma ACE activity at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in nitric oxide (NO) plasma concentrations Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline plasma NO concentration at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary sodium Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary sodium at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary potassium Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary potassium at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary creatinine Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary creatinine at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary magnesium Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary magnesium at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary total protein Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary total protein at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in 24-hour urinary albumin Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary albumin at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in nitric oxide (NO) urinary concentrations Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary NO concentration at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in urinary epinephrine concentrations Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary epinephrine concentration at week 6 (day 41 and 42) of phase 1, 2 and 3
Change in Urinary norepinephrine concentrations Measured at day 1 of phase 1, 2 and 3 (baseline) and change from baseline 24-hour urinary norepinephrine concentration at week 6 (day 41 and 42) of phase 1, 2 and 3
Enrollment 35
Condition
Intervention

Intervention type: Other

Intervention name: Whole hemp seed protein

Description: The intervention will be provided in a form of a smoothie.

Arm group label: Whole hemp seed protein

Intervention type: Other

Intervention name: Whole hemp seed protein plus bioactive peptides

Description: The intervention will be provided in a form of a smoothie.

Arm group label: Whole hemp seed protein plus bioactive peptides

Intervention type: Other

Intervention name: Casein protein

Description: The intervention will be provided in a form of a smoothie.

Arm group label: Casein protein

Eligibility

Criteria:

Inclusion Criteria:

- BMI: 18.5-40 kg/m2

- Systolic blood pressure between 130-160 mmHg

- Diastolic blood pressure <100 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rotimi Aluko, PhD Principal Investigator University of Manitoba
Overall Contact

Last name: Stephanie Jew, BSc

Phone: 204-272-1549

Email: [email protected]

Location
facility status contact investigator Richarson Centre for Funtional Foods and Nutraceuticals Rotimi Aluko, PhD 204-474-9555 [email protected] Rotimi Aluko, PhD Principal Investigator
Location Countries

Canada

Verification Date

November 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Whole hemp seed protein

Arm group type: Experimental

Description: 25 grams of hemp seed protein powder, twice a day

Arm group label: Whole hemp seed protein plus bioactive peptides

Arm group type: Experimental

Description: 22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day

Arm group label: Casein protein

Arm group type: Active Comparator

Description: 25 grams of protein powder, twice a day

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov