Diabetes MellitusPantherNCT02506972
Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal
A study testing Classic Quaker Quick Oats and Cream of Rice Cereal in people with Diabetes Mellitus, run by Glycemic Index Laboratories, Inc at 1 site in Canada.
Trial summary
The purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Classic Quaker Quick Oats and Cream of Rice Cereal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Feb 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- body mass index (BMI) 20.0 - 34.9 kg/m²
Who cannot join
- known to have diabetes
- use of medications considered by the principal investigator to influence glycemic responses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Varying Amounts of β-glucan and Sucrose in Oatmeal on Glycemic Response
The purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal.
- Conditions
- Diabetes Mellitus
- Being tested
- Classic Quaker Quick Oats, Cream of Rice Cereal
- Keywords
- Blood glucose, Humans, Postprandial, Sugar, Carbohydrate, Oat beta-glucan
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Quaker Quick OatsOther
Various doses of oats without or with sugar
Cream of Rice CerealOther
Various doses of cereal without sugar
| Study group | Role | What they receive |
|---|---|---|
| 30g oats | Other | Classic Quick Quaker Oats Receives: Other: Classic Quaker Quick Oats |
| 30g oats plus 9g sugar | Other | Classic Quick Quaker Oats Receives: Other: Classic Quaker Quick Oats |
| 40g oats | Other | Classic Quick Quaker Oats Receives: Other: Classic Quaker Quick Oats |
| 60g oats | Other | Classic Quick Quaker Oats Receives: Other: Classic Quaker Quick Oats |
| 22g cream of rice cereal | Other | Cream of Rice Cereal, B\&G Foods, Inc. Receives: Other: Cream of Rice Cereal |
| 29g cream of rice cereal | Other | Cream of Rice Cereal, B\&G Foods, Inc. Receives: Other: Cream of Rice Cereal |
| 33g cream of rice cereal | Other | Cream of Rice Cereal, B\&G Foods, Inc. Receives: Other: Cream of Rice Cereal |
| 44g cream of rice cereal | Other | Cream of Rice Cereal, B\&G Foods, Inc. Receives: Other: Cream of Rice Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the blood glucose response curve
Measured: For 2 hours after consuming each test meal
Secondary outcomes (5)
Peak rise of blood glucose
The highest concentration of blood glucose achieved after eating minus the fasting blood glucose.
Measured: During 2 hour period after consuming each test meal
Time to peak
The time at which the peak rise of blood glucose occured.
Measured: During 2 hour period after consuming each test meal
Mean rate of decline in blood glucose
The rate of change in blood glucose between consecutive time points (Tx and T(x+1)) was calculated as: Rx = (Gx G(x+1))/(Tx-T(x+1)), where G(x+1) and Gx were the glucose concentrations at times T(x+1) and Tx, respectively. The mean rate of decline in blood glucose (Mean RD) was calculated as the weighted average of all the Rx values from the time of the peak glucose concentration to 120 min, with the weight based on the length of the time interval.
Measured: During 2 hour period after consuming each test meal
Maximum rate of decline in blood glucose
The rate of change in blood glucose between consecutive time points (Tx and T(x+1)) was calculated as: Rx = (Gx G(x+1))/(Tx-T(x+1)), where G(x+1) and Gx were the glucose concentrations at times T(x+1) and Tx, respectively. . The maximum rate in blood glucose decline (Max RD) was calculated as the maximum of all the Rx values from the time of the peak glucose concentration to 120 min.
Measured: During 2 hour period after consuming each test meal
Time to baseline
The time for blood glucose to return to baseline was linearly interpolated between the first blood glucose concentration below fasting and the previous value; if blood glucose did not reach baseline, Bt was taken to be 120min.
Measured: During 2 hour period after consuming each test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycemic Index Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D, Applied Statistics and Consulting
- Responsible party
- Sponsor
- Investigators
- Thomas MS Wolever, MD, PhD, Principal investigator, Glycemic Index Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506972
- Sponsor's protocol ID
- GIL-1404
- Acronym
- Panther
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2015
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolever TMS, van Klinken BJ, Spruill SE, Jenkins AL, Chu Y, Harkness L. Effect of serving size and addition of sugar on the glycemic response elicited by oatmeal: A randomized, cross-over study. Clin Nutr ESPEN. 2016 Dec;16:48-54. doi: 10.1016/j.clnesp.2016.07.003. Epub 2016 Sep 1.
PubMed 28531455
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Varying Amounts of β-glucan and Sucrose in Oatmeal on Glycemic Response
- ClinicalTrials.gov ID
- NCT02506972
- Acronym / sponsor ID
- Panther / GIL-1404
- Conditions
- Diabetes Mellitus
- Keywords
- Blood glucose, Humans, Postprandial, Sugar, Carbohydrate, Oat beta-glucan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Glycemic Index Laboratories, IncIndustry (pharma, biotech, devices)
- Collaborators
- PepsiCo Global R&D, Applied Statistics and Consulting
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Jul 2015 (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 purpose of this study was to determine the impact of serving size and the addition of sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice cereal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 30g oats | Other | Other: Classic Quaker Quick OatsClassic Quick Quaker Oats |
| 30g oats plus 9g sugar | Other | Other: Classic Quaker Quick OatsClassic Quick Quaker Oats |
| 40g oats | Other | Other: Classic Quaker Quick OatsClassic Quick Quaker Oats |
| 60g oats | Other | Other: Classic Quaker Quick OatsClassic Quick Quaker Oats |
| 22g cream of rice cereal | Other | Other: Cream of Rice CerealCream of Rice Cereal, B\&G Foods, Inc. |
| 29g cream of rice cereal | Other | Other: Cream of Rice CerealCream of Rice Cereal, B\&G Foods, Inc. |
| 33g cream of rice cereal | Other | Other: Cream of Rice CerealCream of Rice Cereal, B\&G Foods, Inc. |
| 44g cream of rice cereal | Other | Other: Cream of Rice CerealCream of Rice Cereal, B\&G Foods, Inc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index (BMI) 20.0 - 34.9 kg/m²
Key exclusion criteria (2 listed)
- known to have diabetes
- use of medications considered by the principal investigator to influence glycemic responses
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 |
|---|---|---|
| Classic Quaker Quick OatsVarious doses of oats without or with sugar | Other | 30g oats, 30g oats plus 9g sugar, 40g oats, 60g oats |
| Cream of Rice CerealVarious doses of cereal without sugar | Other | 22g cream of rice cereal, 29g cream of rice cereal, 33g cream of rice cereal, 44g cream of rice cereal |
Primary outcome
Incremental area under the blood glucose response curve
Time frame: For 2 hours after consuming each test meal
5 secondary outcomes
Peak rise of blood glucose
Time frame: During 2 hour period after consuming each test meal
Time to peak
Time frame: During 2 hour period after consuming each test meal
Mean rate of decline in blood glucose
Time frame: During 2 hour period after consuming each test meal
Maximum rate of decline in blood glucose
Time frame: During 2 hour period after consuming each test meal
Time to baseline
Time frame: During 2 hour period after consuming each test meal
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 Jul 2015.
- Derived from this study: PubMed 28531455Wolever TMS, van Klinken BJ, Spruill SE, Jenkins AL, Chu Y, Harkness L. Effect of serving size and addition of sugar on the glycemic response elicited by oatmeal: A randomized, cross-over study. Clin Nutr ESPEN. 2016 Dec;16:48-54. doi: 10.1016/j.clnesp.2016.07.003. Epub 2016 Sep 1.
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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.
Thomas MS Wolever, MD, PhD principal investigator
Glycemic Index Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Quaker Quick Oats and Cream of Rice Cereal in people with Diabetes Mellitus, run by Glycemic Index Laboratories, Inc 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 1 inclusion and 2 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 Jul 2015. 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?
Incremental area under the blood glucose response curve (time frame: For 2 hours after consuming each test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506972, which also lists 1 linked publication.
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 Jul 2015.