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Trial record 1 of 1 for:    hemp | Hypertension | Canada
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Hemp Seed Protein Consumption for Hypertension

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ClinicalTrials.gov Identifier: NCT03508895
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
Manitoba Harvest
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Whole hemp seed protein Other: Whole hemp seed protein plus bioactive peptides Other: Casein protein Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Cross Over Trial of Whole Hemp Seed Protein and Hemp Seed Protein Hydrolysate Derived Bioactive Peptide Consumption for Hypertension
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Experimental: Whole hemp seed protein
25 grams of hemp seed protein powder, twice a day
Other: Whole hemp seed protein
The intervention will be provided in a form of a smoothie.

Experimental: Whole hemp seed protein plus bioactive peptides
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
The intervention will be provided in a form of a smoothie.

Active Comparator: Casein protein
25 grams of protein powder, twice a day
Other: Casein protein
The intervention will be provided in a form of a smoothie.




Primary Outcome Measures :
  1. Change in 24 hour ambulatory blood pressure [ Time Frame: Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3 ]
    Participants will be fitted with an ambulatory blood pressure monitor (ABPM) to wear for 24 hours. Continuous diastolic and systolic blood pressure will be measured over 24 hours.


Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: 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 ]
    Systolic and diastolic blood pressure will be measured using an automated oscillometric measurement device in an office setting in a quiet room while the participant is in a seated position and arm rested on an arm rest at heart level. Participants will be advised to rest quietly throughout the measurements. Measurements will be performed 4 times at 2-minute intervals.

  2. Change in pulse wave velocity (PWV) [ Time Frame: 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 ]
    Measured using an automated oscillometric measurement device (Mobil-O-Graph, IEM, Stolberg, Germany) in an office setting in a quiet room while the participant is in a seated position and arm rested on an arm rest at heart level. Participants will be advised to rest quietly throughout the measurements.

  3. Change in augmentation index (AI) [ Time Frame: 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 ]
    Measured using an automated oscillometric measurement device (Mobil-O-Graph, IEM, Stolberg, Germany) in an office setting in a quiet room while the participant is in a seated position and arm rested on an arm rest at heart level. Participants will be advised to rest quietly throughout the measurements.

  4. Change in body weight [ Time Frame: 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 ]
    Following standardized procedures

  5. Change in waist circumference [ Time Frame: 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 ]
    Following standardized procedures

  6. Change in hip circumference [ Time Frame: 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 ]
    Following standardized procedures

  7. Change in body composition [ Time Frame: Measured at day 1 of phase 1 (baseline) and change from baseline body composition at week 6 of phase 1, 2 and 3 ]
    Looking at potential changes in body fat and lean mass composition by Dual X-ray absorptiometry (DXA). For this procedure, the participant will need to lie in a horizontal position for about 5-15 minutes while the scan arm passes from the head to the feet. The radiation from this test is very low dosage (equivalent to approximately 1 day of natural background radiation).

  8. Change in serum total cholesterol [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  9. Change in serum high-density lipoprotein cholesterol [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  10. Change in serum low-density lipoprotein cholesterol values [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  11. Change in serum triglycerides [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  12. Change in serum glucose [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  13. Change in fasting plasma insulin concentrations [ Time Frame: 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 ]
    Will be determined using radioimmunoassay (RIA) (EMDMillipore, Etobicoke, On, Canada)

  14. Change in insulin homeostasis modelling assessment (HOMA) [ Time Frame: 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 ]
    Will be utilized as an estimate for % β-cell function and insulin resistance (IR)

  15. Change in serum creatinine [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  16. Change in blood urea nitrogen [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  17. Change in serum aspartate aminotransferase [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  18. Change in serum alanine aminotransferase [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  19. Change in serum gamma-glutamyl transferase [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  20. Change in serum total protein [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  21. Change in serum albumin [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  22. Change in serum angiotensin II [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  23. Change in serum aldosterone [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  24. Change in serum renin [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  25. Change in epinephrine [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  26. Change in norepinephrine [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  27. Change in angiotensin-converting enzyme (ACE) activity in the plasma [ Time Frame: 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 ]
    Will be measured by a spectrophotometric method using FAPGG as substrate

  28. Change in nitric oxide (NO) plasma concentrations [ Time Frame: 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 ]
    Will be determined in plasma using a colorimetric kit (Nitric oxide assay, Thermoscientific)

  29. Change in 24-hour urinary sodium [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  30. Change in 24-hour urinary potassium [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  31. Change in 24-hour urinary creatinine [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  32. Change in 24-hour urinary magnesium [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  33. Change in 24-hour urinary total protein [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  34. Change in 24-hour urinary albumin [ Time Frame: 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 ]
    Measured on the cobas c311 (Roche Diagnostics)

  35. Change in nitric oxide (NO) urinary concentrations [ Time Frame: 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 ]
    Will be determined in urine using a colorimetric kit (Nitric oxide assay, Thermoscientific).

  36. Change in urinary epinephrine concentrations [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)

  37. Change in Urinary norepinephrine concentrations [ Time Frame: 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 ]
    Measured using commercial enzyme-linked immunosorbent assays (ELISA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508895


Contacts
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Contact: Stephanie Jew, BSc 204-272-1549 stephanie.jew@umanitoba.ca

Locations
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Canada, Manitoba
Richarson Centre for Funtional Foods and Nutraceuticals Recruiting
Winnipeg, Manitoba, Canada, R3T 6C5
Contact: Peter JH Jones, PhD    204-474-8883    peter.jones@umanitoba.ca   
Principal Investigator: Peter JH Jones, PhD         
Sponsors and Collaborators
University of Manitoba
Heart and Stroke Foundation of Canada
Manitoba Harvest
Investigators
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Principal Investigator: Peter JH Jones, PhD University of Manitoba

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT03508895     History of Changes
Other Study ID Numbers: HS20390 (B2016:125)
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Manitoba:
Hemp protein
Protein hydrolysate
Bioactive peptides
Cannabis sativa

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action