NCT05029427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 28, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

August 26, 2021

Last Update Submit

January 24, 2023

Conditions

Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 to 3 and day 26-28 of each study period

Secondary Outcomes (4)

  • Body weight

    Day 1 and day 28 of each study period

  • Waist circumference

    Day 1 and day 28 of each study period

  • Mean diastolic blood pressure

    Day 1, 2, and 3 and day 26, 27, and 28 of each study period

  • Mean arterial blood pressure

    Day 1, 2, and 3 and day 26, 27, and 28 of each study period

Other Outcomes (1)

  • Dietary fibre by 24 hour recall

    Day 1, 2, and 3 and day 26, 27, and 28 of each study period

Study Arms (2)

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.

Other: High molecular weight β-glucan oat cookiesOther: 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.

Other: High molecular weight β-glucan oat cookiesOther: Control wheat based cookies

Interventions

High molecular weight β-glucan oat cookiesOTHER

Two cookies that contains 4g beta glucan made from oats will be consumed per day.

Study period 1: Wheat ; Study period 2: β-glucan OatStudy period 1: β-glucan Oat ; Study period 2: Wheat
Control wheat based cookiesOTHER

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

Study period 1: Wheat ; Study period 2: β-glucan OatStudy period 1: β-glucan Oat ; Study period 2: Wheat

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Dylan Mackay, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

August 31, 2021

Study Start

November 28, 2021

Primary Completion

December 14, 2022

Study Completion

December 23, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, 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

Locations

CA(1)