Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension
NCT ID: NCT03508895
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2018-07-16
2019-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
FREE Living Hulled HEMP Seed and Oil Trial
NCT02400203
Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
NCT02197910
Enhancing the Benefits of Blueberry Polyphenols With Protein
NCT05967897
SRMA of the Effect of Soy Protein on Blood Pressure
NCT05638061
Phenolic-rich Oats and Artery Improvement
NCT02731755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Whole hemp seed protein
25 grams of hemp seed protein powder, twice a day
Whole hemp seed protein
The intervention was provided in the form of a smoothie.
Whole hemp seed protein plus bioactive peptides
22.5 grams of hemp seed protein and 2.5 grams of hemp seed protein hydrolysate derived bioactive peptides, twice a day
Whole hemp seed protein plus bioactive peptides
The intervention was provided in the form of a smoothie.
Casein protein
25 grams of protein powder, twice a day
Casein protein
The intervention was provided in the form of a smoothie.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Whole hemp seed protein
The intervention was provided in the form of a smoothie.
Whole hemp seed protein plus bioactive peptides
The intervention was provided in the form of a smoothie.
Casein protein
The intervention was provided in the form of a smoothie.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heart and Stroke Foundation of Canada
OTHER
Manitoba Harvest
OTHER
University of Manitoba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rotimi Aluko, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Richardson Centre for Food Technology and Research
Winnipeg, Manitoba, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS20390 (B2016:125)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.