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Protein Supplement

Whole hemp seed protein for High Blood Pressure

N/A
Waitlist Available
Led By Rotimi Aluko, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24 hour ambulatory blood pressure
Secondary outcome measures
Body Weight Changes
Change in nitric oxide (NO) plasma concentrations
Change in plasma catalase (CAT) concentration
+5 more
Other outcome measures
Change in augmentation index (AI)
Change in blood pressure
Change in body composition
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Whole hemp seed protein plus bioactive peptidesExperimental Treatment1 Intervention
22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day
Group II: Whole hemp seed proteinExperimental Treatment1 Intervention
25 grams of hemp seed protein powder, twice a day
Group III: Casein proteinActive Control1 Intervention
25 grams of protein powder, twice a day

Find a Location

Who is running the clinical trial?

Manitoba HarvestOTHER
2 Previous Clinical Trials
46 Total Patients Enrolled
University of ManitobaLead Sponsor
598 Previous Clinical Trials
199,585 Total Patients Enrolled
Heart and Stroke Foundation of CanadaOTHER
124 Previous Clinical Trials
72,295 Total Patients Enrolled
~5 spots leftby Aug 2025