NCT03508895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

April 22, 2024

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

March 29, 2018

Last Update Submit

April 18, 2024

Conditions

Hypertension

Keywords

Hemp seed proteinProtein hydrolysateBioactive peptidesCannabis sativaHigh blood pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Change in serum renin concentration

    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 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

    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

    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

    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

  • +3 more secondary outcomes

Other Outcomes (7)

  • Change in blood pressure

    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 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 at day 1 of phase 1, 2 and 3 (baseline) and change from baseline AI at week 6 of phase 1, 2 and 3

  • +4 more other outcomes

Study Arms (3)

Whole hemp seed protein

EXPERIMENTAL

25 grams of hemp seed protein powder, twice a day

Other: Whole hemp seed protein

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

Other: Whole hemp seed protein plus bioactive peptides

Casein protein

ACTIVE COMPARATOR

25 grams of protein powder, twice a day

Other: Casein protein

Interventions

Whole hemp seed proteinOTHER

The intervention was provided in the form of a smoothie.

Whole hemp seed protein
Whole hemp seed protein plus bioactive peptidesOTHER

The intervention was provided in the form of a smoothie.

Whole hemp seed protein plus bioactive peptides
Casein proteinOTHER

The intervention was provided in the form of a smoothie.

Casein protein

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI: 18.5-40 kg/m2
  • Systolic blood pressure between 130-160 mmHg
  • Diastolic blood pressure ≤ 110 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Food Technology and Research

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 38710445DERIVED

  • 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.

    PMID: 32326966DERIVED

MeSH Terms

Conditions

HypertensionMarijuana Abuse

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Rotimi Aluko, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 26, 2018

Study Start

July 16, 2018

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

April 22, 2024

Record last verified: 2022-12

Locations

CA(1)