NormoglycemicNCT02651597
A Study of the Effect of Oats on Post Prandial Glucose Response
A study testing Oatmeal in people with Normoglycemic and Normal Body Weight, run by University of Manitoba at 1 site in Canada.
Trial summary
The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normoglycemic, Normal Body Weight
- What is being tested?
- Oatmeal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to 10 Dec 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normoglycemic (<5.6 mmol/L)
- BMI= 18.5-29.9 kg/m²
Who cannot join
- A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- Daily tobacco use.
- Eat meals at irregular or unusual times.
- Food allergy, aversion or unwillingness to eat study foods.
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
- Presence of a gastrointestinal disorder.
- Currently pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.
Read the detailed description
The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.
Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.
Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).
Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .
Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.
During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.
- Conditions
- Normoglycemic, Normal Body Weight
- Being tested
- Oatmeal
- Keywords
- Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OatmealOther
| Study group | Role | What they receive |
|---|---|---|
| Low Viscous | Experimental | Low Viscous Beta Glucan Oatmeal Receives: Other: Oatmeal |
| Medium Viscous | Experimental | Medium Viscous Beta Glucan Oatmeal Receives: Other: Oatmeal |
| High Viscous | Experimental | High Viscous Beta Glucan Oatmeal Receives: Other: Oatmeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Total area under the curve (iAUC, mmol*min/L) for glucose
Measured: 0-200 mins
Secondary outcomes (4)
Appetite (visual analogue scales)
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Measured: 0-200 mins
Physical Comfort
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Measured: 0-200 mins
Energy/Fatigue
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Measured: 0-200mins
Palatability
Measured by VAS questionnaire at 12 time points used to calculate area under curve
Measured: at 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion10 Dec 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormoglycemicStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Sponsor
- Investigators
- Peter Jones, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651597
- Sponsor's protocol ID
- B2015:142
- Status last verified
- Apr 2021
- First submitted
- 6 Jan 2016
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
- ClinicalTrials.gov ID
- NCT02651597
- Acronym / sponsor ID
- B2015:142
- Conditions
- Normoglycemic, Normal Body Weight
- Keywords
- Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D
- Study start
- Apr 2016
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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 objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.
Detailed description
The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited.
Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit.
Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS).
Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters .
Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week.
During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Viscous | Experimental | Other: OatmealLow Viscous Beta Glucan Oatmeal |
| Medium Viscous | Experimental | Other: OatmealMedium Viscous Beta Glucan Oatmeal |
| High Viscous | Experimental | Other: OatmealHigh Viscous Beta Glucan Oatmeal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normoglycemic (<5.6 mmol/L)
- BMI= 18.5-29.9 kg/m²
Key exclusion criteria (7 listed)
- A change in medication (dose or type) or medical event requiring hospitalization within the past month.
- Daily tobacco use.
- Eat meals at irregular or unusual times.
- Food allergy, aversion or unwillingness to eat study foods.
- Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar.
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 |
|---|---|---|
| Oatmeal | Other | High Viscous, Low Viscous, Medium Viscous |
Primary outcome
Blood Glucose
Time frame: 0-200 mins
Total area under the curve (iAUC, mmol*min/L) for glucose
4 secondary outcomes
Appetite (visual analogue scales)
Time frame: 0-200 mins
Physical Comfort
Time frame: 0-200 mins
Energy/Fatigue
Time frame: 0-200mins
Palatability
Time frame: at 5 mins
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 23 Jan 2023.
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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.
Peter Jones, 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 Oatmeal in people with Normoglycemic and Normal Body Weight, 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 2 inclusion and 7 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 23 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?
Blood Glucose (time frame: 0-200 mins). 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 23 Jan 2023.