Effect of Oat Beta Glucan in Managing Blood Pressure

• ClinicalTrials.gov Identifier: NCT05029427
• Recruitment Status: Recruiting
• First Posted: August 31, 2021
• Last Update Posted: June 22, 2022
• Sponsor: University of Manitoba
• Collaborator: Agriculture and Agri-Food Canada
• Information provided by (Responsible Party): University of Manitoba

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Dylan Mackay, PhD; University of Manitoba

More Information

• Responsible Party: University of Manitoba
• ClinicalTrials.gov Identifier: NCT05029427
• Other Study ID Numbers: HS24522(B2020:127)
• First Posted: August 31, 2021
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases