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Effect of Oat Beta Glucan in Managing Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05029427
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
University of Manitoba

Brief 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.

Condition or disease Intervention/treatment Phase
Elevated Blood Pressure Other: High molecular weight β-glucan oat cookies Other: Control wheat based cookies Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Treatments will be provided to participants' homes via delivery. The treatments will be in similar looking breakfast cookies that will be prepared and delivered people outside of the clinical trial team.
Primary Purpose: Basic Science
Official Title: Effect of Oat Beta Glucan in Managing Blood Pressure: a Randomized Cross-over Pilot Trial
Actual Study Start Date : November 28, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : October 31, 2022


Arm Intervention/treatment
Experimental: Study period 1: β-glucan Oat ; Study period 2: Wheat
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.
Other: High molecular weight β-glucan oat cookies
Two cookies that contains 4g beta glucan made from oats will be consumed per day.

Other: Control wheat based cookies
Two cookies that made from cream of wheat without beta glucan will be consumed per day.

Experimental: Study period 1: Wheat ; Study period 2: β-glucan Oat
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.
Other: High molecular weight β-glucan oat cookies
Two cookies that contains 4g beta glucan made from oats will be consumed per day.

Other: Control wheat based cookies
Two cookies that made from cream of wheat without beta glucan will be consumed per day.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Day 1 and day 28 of each study period ]
    Body weight will be measured in kg to the nearest 0.1 kg using a digital scale

  2. Waist circumference [ Time Frame: Day 1 and day 28 of each study period ]
    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

  3. Mean diastolic blood pressure [ Time Frame: Day 1, 2, and 3 and day 26, 27, and 28 of each study period ]
    The mean diastolic blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine

  4. Mean arterial blood pressure [ Time Frame: Day 1, 2, and 3 and day 26, 27, and 28 of each study period ]
    The mean arterial blood pressure will be measured for 24 hours for 3 consecutive days with an ambulatory blood pressure machine


Other Outcome Measures:
  1. Dietary fibre by 24 hour recall [ Time Frame: Day 1, 2, and 3 and day 26, 27, and 28 of each study period ]
    Food recalls will be collected through Automated Self-Administered 24-hour dietary assessment tool and analyzed for consumption of dietary fibre



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05029427


Contacts
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Contact: Rebecca Mollard, PhD 204-631-3834 rmollard@sogh.mb.ca

Locations
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Canada, Manitoba
Chronic Disease Innovation Centre, Seven Oaks Hospital Recruiting
Winnipeg, Manitoba, Canada, R2V 3M3
Contact: Rebecca Mollard, PhD    204-631-3834    rmollard@sogh.mb.ca   
Contact: Reid Whitlock    204-632-3383    rwgutkicj@sogh.mb.ca   
Principal Investigator: Dylan MacKay, PhD         
Sub-Investigator: Navdeep Tangri, MD, PHD         
Sub-Investigator: Rebecca Mollard, PhD         
Sub-Investigator: Sijo Joseph, PhD         
Sub-Investigator: Nancy Ames, PhD         
Sub-Investigator: Thomas Netticadan, PhD         
Sponsors and Collaborators
University of Manitoba
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Dylan Mackay, PhD University of Manitoba
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT05029427    
Other Study ID Numbers: HS24522(B2020:127)
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: The data will be available following the publication of the primary results manuscript, and for a period of 25 years.
Access Criteria: Reasonable request to the principle investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases