Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
| Manitoba Harvest | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole hemp seed protein | Experimental | 25 grams of hemp seed protein powder, twice a day |
|
| Whole hemp seed protein plus bioactive peptides | Experimental | 22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day |
|
| Casein protein | Active Comparator | 25 grams of protein powder, twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole hemp seed protein | Other | The intervention was provided in the form of a smoothie. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum renin concentration | 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 concentration at day 42 of phase 1, 2 and 3 |
| Change in angiotensin-converting enzyme (ACE) activity in the plasma |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rotimi Aluko, PhD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richardson Centre for Food Technology and Research | Winnipeg | Manitoba | R3T 6C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38710445 | Derived | Samsamikor M, Mackay DS, Mollard RC, Alashi AM, Aluko RE. Hemp seed protein and its hydrolysate compared with casein protein consumption in adults with hypertension: a double-blind crossover study. Am J Clin Nutr. 2024 Jul;120(1):56-65. doi: 10.1016/j.ajcnut.2024.05.001. Epub 2024 May 4. | |
| 32326966 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Whole hemp seed protein plus bioactive peptides | Other | The intervention was provided in the form of a smoothie. |
|
| Casein protein | Other | The intervention was provided in the form of a smoothie. |
|
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) concentration | 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) concentration | 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) concentration | 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) 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 | 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 | 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 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. | 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. | 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 | 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 | 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 | 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). | Measured at day 1 of phase 1 (baseline) and change from baseline body composition at week 6 of phase 1, 2 and 3 |
| 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. |
| D001523 | Mental Disorders |