- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506972
Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal (Panther)
July 22, 2015 updated by: Glycemic Index Laboratories, Inc
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2N8
- Glycemic Index Laboratories, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- body mass index (BMI) 20.0 - 34.9 kg/m²
Exclusion Criteria:
- known to have diabetes
- use of medications considered by the principal investigator to influence glycemic responses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 30g oats
Classic Quick Quaker Oats
|
Various doses of oats without or with sugar
|
|
Other: 30g oats plus 9g sugar
Classic Quick Quaker Oats
|
Various doses of oats without or with sugar
|
|
Other: 40g oats
Classic Quick Quaker Oats
|
Various doses of oats without or with sugar
|
|
Other: 60g oats
Classic Quick Quaker Oats
|
Various doses of oats without or with sugar
|
|
Other: 22g cream of rice cereal
Cream of Rice Cereal, B&G Foods, Inc.
|
Various doses of cereal without sugar
|
|
Other: 29g cream of rice cereal
Cream of Rice Cereal, B&G Foods, Inc.
|
Various doses of cereal without sugar
|
|
Other: 33g cream of rice cereal
Cream of Rice Cereal, B&G Foods, Inc.
|
Various doses of cereal without sugar
|
|
Other: 44g cream of rice cereal
Cream of Rice Cereal, B&G Foods, Inc.
|
Various doses of cereal without sugar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incremental area under the blood glucose response curve
Time Frame: For 2 hours after consuming each test meal
|
For 2 hours after consuming each test meal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak rise of blood glucose
Time Frame: During 2 hour period after consuming each test meal
|
The highest concentration of blood glucose achieved after eating minus the fasting blood glucose.
|
During 2 hour period after consuming each test meal
|
|
Time to peak
Time Frame: During 2 hour period after consuming each test meal
|
The time at which the peak rise of blood glucose occured.
|
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
|
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.
|
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
|
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.
|
During 2 hour period after consuming each test meal
|
|
Time to baseline
Time Frame: During 2 hour period after consuming each test meal
|
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.
|
During 2 hour period after consuming each test meal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimate)
July 23, 2015
Study Record Updates
Last Update Posted (Estimate)
July 23, 2015
Last Update Submitted That Met QC Criteria
July 22, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- GIL-1404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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