Elevated Blood PressureNCT05029427
Effect of Oat Beta Glucan in Managing Blood Pressure
A study testing High molecular weight β-glucan oat cookies in people with Elevated Blood Pressure, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a randomized, double-blinded, cross-over pilot study comparing the effects of ingesting oats containing high molecular weight β-glucan in reducing blood pressure. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- High molecular weight β-glucan oat cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2021to 23 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Generally healthy male and non-pregnant/lactating female, between the ages of 40-75
- When measured by the ambulatory blood pressure monitor, average systolic blood pressure (between 120 and 150mm Hg) and diastolic blood pressure (between 75 and 100mm Hg)
- Willing to comply with protocol requirements
- Willing to maintain their current weight and activity level throughout the study
- Body mass index 18.5-35kg/m2
Who cannot join
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Body mass index ≤ 18.4 and ≥ 35.1 kg/m2
- If there is a history of a secondary cause of hypertension
- Ambulatory blood pressure monitor, systolic blood pressure >150mm Hg or <120mm Hg, diastolic pressure >100mm Hg or <75 mm Hg
- Use of medications containing pseudoephedrine or other vasoconstricting agents
- Antihypertensive drug treatment, regular high dose nonsteroidal anti-inflammatory drugs (NSAID) treatment and the use of cyclosporine or tacrolimus
Show all 18Show fewer
- Cardiovascular disease including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening
- Not willing to maintain their regular physical activity level throughout the intervention
- Use of omega-3 fatty acid, herbal supplements or weight loss drugs
- Diagnosis of diabetes type 1 or type 2
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- Any other significant disease or disorder which, in the opinion of the Investigator or study physician, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- Recent history (within 6 month of screening) or current consumption of >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- Body weight change over 3.5kg for the past 3 months
- Smokers and tobacco/snuff/nicotine users
- Allergy to oats, wheat, peanut, apple, cherry, blueberry, quinoa, egg white, margarine and vanilla extract.
- Regular consumption of supplements which may influence blood pressure/consumption of food supplements targeted to blood pressure lowering within 30 days before and during the study
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks
Trial locations and contacts
1 site in 1 country.
Canada1 site
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Effect of Oat Beta Glucan in Managing Blood Pressure: a Randomized Cross-over Pilot Trial
This is a randomized, double-blinded, cross-over pilot study comparing the effects of ingesting oats containing high molecular weight β-glucan in reducing blood pressure.
Read the detailed description
The pilot study will consist of 2 study periods: one treatment period and one control period. The treatment period will provide food products made from oats containing a total of 4 grams per day high molecular weight (HMW) oat β-glucan, whereas, the control period will provide food products made primarily from wheat with no β-glucan. The study will be located at the Chronic Disease Innovation Centre in Seven Oaks General Hospital, Winnipeg, Canada.
The primary objective of this study is to investigate the effect of ingestion of HMW oat β-glucan on ambulatory blood pressure. Participants will be asked to wear an ambulatory blood pressure monitor for 24 hours per day for 3 consecutive days at the beginning and end of each treatment period. This device automatically measures blood pressure every 15-30 minutes during the day and 30 to 60 minutes during the evening.
The study has been designed to be conducted virtually. Participants will consent to receive both treatment and control over two 4-week periods online. The participants will be randomized to different orders of treatment, with a 4 week wash out period in between.
- Conditions
- Elevated Blood Pressure
- Being tested
- High molecular weight β-glucan oat cookies, Control wheat based cookies
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High molecular weight β-glucan oat cookiesOther
Two cookies that contains 4g beta glucan made from oats will be consumed per day.
Control wheat based cookiesOther
Two cookies that made from cream of wheat without beta glucan will be consumed per day.
| Study group | Role | What they receive |
|---|---|---|
| Study period 1: β-glucan Oat ; Study period 2: Wheat | Experimental | For the first period, the participant will receive food products made from oats containing a total of 4 grams per day HMW oat β-glucan. For the second period, the participant will receive food products made from wheat. Receives: Other: High molecular weight β-glucan oat cookies; Other: Control wheat based cookies |
| Study period 1: Wheat ; Study period 2: β-glucan Oat | Experimental | For the first period, the participant will receive food products made from wheat. For the second period, the participant will receive food products made from oats containing a total of 4 grams per day HMW oat β-glucan. Receives: Other: High molecular weight β-glucan oat cookies; Other: Control wheat based cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean systolic blood pressure
The mean systolic blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine
Measured: Day 1 to 3 and day 26-28 of each study period
Secondary outcomes (4)
Body weight
Body weight will be measured in kg to the nearest 0.1 kg using a digital scale
Measured: Day 1 and day 28 of each study period
Waist circumference
Waist circumference in cm will be measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and iliac crest using a fibreglass tape
Measured: Day 1 and day 28 of each study period
Mean diastolic blood pressure
The mean diastolic blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine
Measured: Day 1, 2, and 3 and day 26, 27, and 28 of each study period
Mean arterial blood pressure
The mean arterial blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine
Measured: Day 1, 2, and 3 and day 26, 27, and 28 of each study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start28 Nov 2021
- Primary completion14 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Sponsor
- Investigators
- Dylan Mackay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029427
- Sponsor's protocol ID
- HS24522(B2020:127)
- Status last verified
- Jan 2023
- First submitted
- 26 Aug 2021
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) may be deposited in a repository if required by the journal where the results are published, otherwise it will be available upon request to the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oat Beta Glucan in Managing Blood Pressure: a Randomized Cross-over Pilot Trial
- ClinicalTrials.gov ID
- NCT05029427
- Acronym / sponsor ID
- HS24522(B2020:127)
- Conditions
- Elevated Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blinded, cross-over pilot study comparing the effects of ingesting oats containing high molecular weight β-glucan in reducing blood pressure.
Detailed description
The pilot study will consist of 2 study periods: one treatment period and one control period. The treatment period will provide food products made from oats containing a total of 4 grams per day high molecular weight (HMW) oat β-glucan, whereas, the control period will provide food products made primarily from wheat with no β-glucan. The study will be located at the Chronic Disease Innovation Centre in Seven Oaks General Hospital, Winnipeg, Canada.
The primary objective of this study is to investigate the effect of ingestion of HMW oat β-glucan on ambulatory blood pressure. Participants will be asked to wear an ambulatory blood pressure monitor for 24 hours per day for 3 consecutive days at the beginning and end of each treatment period. This device automatically measures blood pressure every 15-30 minutes during the day and 30 to 60 minutes during the evening.
The study has been designed to be conducted virtually. Participants will consent to receive both treatment and control over two 4-week periods online. The participants will be randomized to different orders of treatment, with a 4 week wash out period in between.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study period 1: β-glucan Oat ; Study period 2: Wheat | Experimental | Other: High molecular weight β-glucan oat cookies, Other: Control wheat based cookiesFor the first period, the participant will receive food products made from oats containing a total of 4 grams per day HMW oat β-glucan. For the second period, the participant will receive food products made from wheat. |
| Study period 1: Wheat ; Study period 2: β-glucan Oat | Experimental | Other: High molecular weight β-glucan oat cookies, Other: Control wheat based cookiesFor the first period, the participant will receive food products made from wheat. For the second period, the participant will receive food products made from oats containing a total of 4 grams per day HMW oat β-glucan. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Generally healthy male and non-pregnant/lactating female, between the ages of 40-75
- When measured by the ambulatory blood pressure monitor, average systolic blood pressure (between 120 and 150mm Hg) and diastolic blood pressure (between 75 and 100mm Hg)
- Willing to comply with protocol requirements
- Willing to maintain their current weight and activity level throughout the study
Key exclusion criteria (18 listed)
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Body mass index ≤ 18.4 and ≥ 35.1 kg/m2
- If there is a history of a secondary cause of hypertension
- Ambulatory blood pressure monitor, systolic blood pressure >150mm Hg or <120mm Hg, diastolic pressure >100mm Hg or <75 mm Hg
- Use of medications containing pseudoephedrine or other vasoconstricting agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High molecular weight β-glucan oat cookiesTwo cookies that contains 4g beta glucan made from oats will be consumed per day. | Other | Study period 1: Wheat ; Study period 2: β-glucan Oat, Study period 1: β-glucan Oat ; Study period 2: Wheat |
| Control wheat based cookiesTwo cookies that made from cream of wheat without beta glucan will be consumed per day. | Other | Study period 1: Wheat ; Study period 2: β-glucan Oat, Study period 1: β-glucan Oat ; Study period 2: Wheat |
Primary outcome
Mean systolic blood pressure
Time frame: Day 1 to 3 and day 26-28 of each study period
The mean systolic blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine
4 secondary outcomes
Body weight
Time frame: Day 1 and day 28 of each study period
Waist circumference
Time frame: Day 1 and day 28 of each study period
Mean diastolic blood pressure
Time frame: Day 1, 2, and 3 and day 26, 27, and 28 of each study period
Mean arterial blood pressure
Time frame: Day 1, 2, and 3 and day 26, 27, and 28 of each study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) may be deposited in a repository if required by the journal where the results are published, otherwise it will be available upon request to the principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Mackay, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High molecular weight β-glucan oat cookies in people with Elevated Blood Pressure, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure (time frame: Day 1 to 3 and day 26-28 of each study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.