Blood GlucoseNCT04260425
A Pilot Study Evaluating Oat Polyphenols on Post-prandial Glucose Response
A study testing Serving of oatmeal made from low avenanthramides oats and water and Serving of oatmeal made from high avenanthramides oats and water in people with Blood Glucose, run by University of Manitoba at 1 site in Canada.
Trial summary
The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose
- What is being tested?
- Serving of oatmeal made from low avenanthramides oats and water and Serving of oatmeal made from high avenanthramides oats and water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2021to 28 Mar 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m^2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
- In the Investigator's opinion is able and willing to comply with all trial requirements
Who cannot join
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish consuming the study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
- Intolerance or allergic reaction to oats
Show all 13Show fewer
- Existing restrictive dietary habits (such a vegan, low carbohydrate or keto)
- Uncontrolled hypertension
- History of cancer within the last two years (except for non-melanoma skin cancer)
- Recent history of (within 12 month of screening) or current strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
- Body weight change over 3.5kg within the past 3 months
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- Had significant physical trauma or major surgery in the past 3 month or had trauma or major surgery in the past 3 month
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Center for Food Technology and Research
Winnipeg, Manitoba, R3T 2E1
About this study
Official title: A Randomized Controlled Pilot Study Evaluating the Effect of Oat Polyphenols on Post-prandial Glucose Response in Healthy Adults.
The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults.
Read the detailed description
The clinical trial will follow a two period acute double-blind cross-over design. It will take place at Richardson Centre for Functional Food and Nutraceuticals (RCFFN) at University of Manitoba, Winnipeg, Canada.
The trial will recruit healthy adult participants. Participants will consent to participate in two acute feeding sessions. Participants will be randomized to either control (low avenanthramides) then treatment (high avenanthramides) or treatment then control. Participants will arrive at the study center fasted between 8 and 10:30 am on the session days. They will be provided either the study treatment or control product based on randomization sequence for their first study visit. Baseline blood glucose (0 min) will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product, and at 15, 30, 45, 60, 90 and 120 mins after baseline. The timer will be started when they take their first bite. During the second visit participant will consume the other treatment based on the randomization (the oatmeal that they didn't receive in their first visit and follow exactly the same procedure as the first visit). There will be a minimum of 5 days between sessions. Female participants will be scheduled during the luteal phase of their menstruation cycle. There will be a maximum of 8 weeks between the two sessions, therefore, participants will finish the both sessions within an 8 week period.
- Conditions
- Blood Glucose
- Being tested
- Serving of oatmeal made from low avenanthramides oats and water, Serving of oatmeal made from high avenanthramides oats and water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serving of oatmeal made from low avenanthramides oats and waterOther
One serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
Serving of oatmeal made from high avenanthramides oats and waterOther
One serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
| Study group | Role | What they receive |
|---|---|---|
| High then low avenanthramides content oats | Experimental | This arm will receive the high avenanthramides content oatmeal at the first session and the low avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart. Receives: Other: Serving of oatmeal made from low avenanthramides oats and water; Other: Serving of oatmeal made from high avenanthramides oats and water |
| Low then high avenanthramides content oats | Experimental | This arm will receive the low avenanthramides content oatmeal at the first session and the high avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart. Receives: Other: Serving of oatmeal made from low avenanthramides oats and water; Other: Serving of oatmeal made from high avenanthramides oats and water |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-prandial glucose response
2 hour area under the curve of post-prandial glucose response to the interventions in mmol/L*min^2
Measured: Area under the curve from 0,15, 30, 45, 60, 90 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start28 Nov 2021
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Responsible party
- Principal investigator, Dylan MacKay. PhD, University of Manitoba
- Investigators
- Dylan Mackay, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260425
- Sponsor's protocol ID
- HS23437 (B2019:114)
- Status last verified
- Sep 2022
- First submitted
- 5 Feb 2020
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study Evaluating the Effect of Oat Polyphenols on Post-prandial Glucose Response in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04260425
- Acronym / sponsor ID
- HS23437 (B2019:114)
- Conditions
- Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Agriculture and Agri-Food Canada
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 7 Feb 2020 (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.
The trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides (AV) on post-prandial blood glucose response in healthy adults.
Detailed description
The clinical trial will follow a two period acute double-blind cross-over design. It will take place at Richardson Centre for Functional Food and Nutraceuticals (RCFFN) at University of Manitoba, Winnipeg, Canada.
The trial will recruit healthy adult participants. Participants will consent to participate in two acute feeding sessions. Participants will be randomized to either control (low avenanthramides) then treatment (high avenanthramides) or treatment then control. Participants will arrive at the study center fasted between 8 and 10:30 am on the session days. They will be provided either the study treatment or control product based on randomization sequence for their first study visit. Baseline blood glucose (0 min) will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product, and at 15, 30, 45, 60, 90 and 120 mins after baseline. The timer will be started when they take their first bite. During the second visit participant will consume the other treatment based on the randomization (the oatmeal that they didn't receive in their first visit and follow exactly the same procedure as the first visit). There will be a minimum of 5 days between sessions. Female participants will be scheduled during the luteal phase of their menstruation cycle. There will be a maximum of 8 weeks between the two sessions, therefore, participants will finish the both sessions within an 8 week period.
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 |
|---|---|---|
| High then low avenanthramides content oats | Experimental | Other: Serving of oatmeal made from low avenanthramides oats and water, Other: Serving of oatmeal made from high avenanthramides oats and waterThis arm will receive the high avenanthramides content oatmeal at the first session and the low avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart. |
| Low then high avenanthramides content oats | Experimental | Other: Serving of oatmeal made from low avenanthramides oats and water, Other: Serving of oatmeal made from high avenanthramides oats and waterThis arm will receive the low avenanthramides content oatmeal at the first session and the high avenanthramides content oatmeal at the second session. Sessions will be at least 5 days apart. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female between 18-50 years old
- BMI range in between 18.9-29.9 kg/m^2
- Fasting glucose <5.6 mmol/L
- Usually eat breakfast
Key exclusion criteria (13 listed)
- Fasting glucose ≥ 5.6 mmol/L or <3.5 mmol/L
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who indicate that they could not finish consuming the study treatments within 10 minutes
- Use of medication or supplements that may influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of screening visit
- History of disordered eating, AIDS, hepatitis, a history of clinically important endocrine (including Type I and Type II diabetes mellitus), cardiovascular (including but not limit to atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders
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 |
|---|---|---|
| Serving of oatmeal made from low avenanthramides oats and waterOne serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout. | Other | High then low avenanthramides content oats, Low then high avenanthramides content oats |
| Serving of oatmeal made from high avenanthramides oats and waterOne serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout. | Other | High then low avenanthramides content oats, Low then high avenanthramides content oats |
Primary outcome
post-prandial glucose response
Time frame: Area under the curve from 0,15, 30, 45, 60, 90 and 120 minutes
2 hour area under the curve of post-prandial glucose response to the interventions in mmol/L*min^2
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 13 Sep 2022.
Related trials for Blood Glucose
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Recruiting
RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus
Diabetes (DM)
Not yet recruitingPhase 3
Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes
Overweight or Obesity Without Diabetes
RecruitingPhase 1
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
High Blood Sugar, High Blood Pressure
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 Serving of oatmeal made from low avenanthramides oats and water and Serving of oatmeal made from high avenanthramides oats and water in people with Blood Glucose, 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 13 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 13 Sep 2022. 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?
post-prandial glucose response (time frame: Area under the curve from 0,15, 30, 45, 60, 90 and 120 minutes). 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 13 Sep 2022.