Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension

NCT03508895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-04-22

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Whole hemp seed protein

The intervention was provided in the form of a smoothie.

OTHER

Whole hemp seed protein plus bioactive peptides

The intervention was provided in the form of a smoothie.

OTHER

Casein protein

The intervention was provided in the form of a smoothie.

Sponsors & Collaborators

  • Heart and Stroke Foundation of Canada

    collaborator OTHER
  • Manitoba Harvest

    collaborator OTHER
  • University of Manitoba

    lead OTHER

Principal Investigators

  • Rotimi Aluko, PhD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-11-15
Completion
2019-11-15

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508895 on ClinicalTrials.gov