Hemp Seed Protein and Bioactive Peptides Consumption for Hypertension

NCT ID: NCT03508895

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2019-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Whole hemp seed protein

25 grams of hemp seed protein powder, twice a day

Group Type EXPERIMENTAL

Whole hemp seed protein

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Whole hemp seed protein plus bioactive peptides

Intervention Type OTHER

The intervention was provided in the form of a smoothie.

Casein protein

25 grams of protein powder, twice a day

Group Type ACTIVE_COMPARATOR

Casein protein

Intervention Type OTHER

The intervention was provided in the form of a smoothie.

Interventions

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Whole hemp seed protein

The intervention was provided in the form of a smoothie.

Intervention Type OTHER

Whole hemp seed protein plus bioactive peptides

The intervention was provided in the form of a smoothie.

Intervention Type OTHER

Casein protein

The intervention was provided in the form of a smoothie.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

Manitoba Harvest

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rotimi Aluko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Richardson Centre for Food Technology and Research

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38710445 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32326966 (View on PubMed)

Other Identifiers

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HS20390 (B2016:125)

Identifier Type: -

Identifier Source: org_study_id

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