An interventional study of Whole hemp seed protein and Whole hemp seed protein plus bioactive peptides in Hypertension, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 35 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
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Exclusion Criteria:
25 grams of hemp seed protein powder, twice a day
Other: Whole hemp seed protein
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
25 grams of protein powder, twice a day
Other: Casein protein
The intervention was provided in the form of a smoothie.
The intervention was provided in the form of a smoothie.
The intervention was provided in the form of a smoothie.
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.
Time frame: Measured at day 1 of phase 1 (baseline) and change from baseline ABP at week 6 of phase 1, 2 and 3
Change in serum renin concentration
Measured using a fluorometric microplate reader (Spectra MAX Gemini, Molecular Devices, Sunnyvale, CA).
Time frame: 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
Change in angiotensin-converting enzyme (ACE) activity in the plasma
Measured using spectrophotometric method with furanacryloyl-L-phenylalanylglycylglycine (FAPGG) as substrate
Time frame: 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)
Time frame: 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) concentration
Was determined using OxiSelec ROS/RNS assay kit and fluorescence plate reader at 480 nm excitation / 530 nm emission
Time frame: 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) concentration
Was determined using microplate reader at 500 nm
Time frame: 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) concentration
SOD OxiSelect assay kit (Cell Biolabs, Inc., San Diego, CA, USA) and microplate reader at 490 nm were used for this assay
Time frame: 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) concentration
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
Time frame: 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
Change in plasma free oxylipin concentrations
HPLC/MS/MS by using a Luna 5μm C18 column on a Shimadzu Nexera XR HPLC, coupled to an ABSciex QTRAP 6500 MS
Time frame: 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
Change in blood pressure
Systolic and diastolic blood pressure were measured using an automated oscillometric measurement device in an office setting in a quiet room while the participant wass in a seated position and arm rested on an arm rest at heart level. Participants were advised to rest quietly throughout the measurements. Measurements were performed 4 times at 2-minute intervals.
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
Change in pulse wave velocity (PWV)
Measured using an automated oscillometric measurement device (Mobil-O-Graph, IEM, Stolberg, Germany) in an office setting in a quiet room while the participant was in a seated position and arm rested on an arm rest at heart level. Participants were advised to rest quietly throughout the measurements.
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
Change in augmentation index (AI)
Measured using an automated oscillometric measurement device (Mobil-O-Graph, IEM, Stolberg, Germany) in an office setting in a quiet room while the participant was in a seated position and arm rested on an arm rest at heart level. Participants were advised to rest quietly throughout the measurements.
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
Change in body weight
Following standardized procedures
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
Change in waist circumference
Following standardized procedures
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
Change in hip circumference
Following standardized procedures
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
Change in body composition
Looking at potential changes in body fat and lean mass composition by Dual X-ray absorptiometry (DXA). For this procedure, the participant were needed 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 was very low dosage (equivalent to approximately 1 day of natural background radiation).
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
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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University of Manitoba