Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal

Diabetes Mellitus Clinical Trial

— Panther  

Official title:

Effect of Varying Amounts of β-glucan and Sucrose in Oatmeal on Glycemic Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506972
• Other study ID #: GIL-1404
• Status: Completed
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 22, 2015
• Start date: November 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Classic Quaker Quick Oats
Various doses of oats without or with sugar
• Cream of Rice Cereal
Various doses of cereal without sugar

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc.	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	Applied Statistics and Consulting, PepsiCo Global R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the blood glucose response curve		For 2 hours after consuming each test meal	No
Secondary	Peak rise of blood glucose	The highest concentration of blood glucose achieved after eating minus the fasting blood glucose.	During 2 hour period after consuming each test meal	No
Secondary	Time to peak	The time at which the peak rise of blood glucose occured.	During 2 hour period after consuming each test meal	No
Secondary	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.	During 2 hour period after consuming each test meal	No
Secondary	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.	During 2 hour period after consuming each test meal	No
Secondary	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.	During 2 hour period after consuming each test meal	No