Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02651597
Status:
COMPLETED
Last Update Posted:
2023-01-23
First Post:
2016-01-06
Brief Title:
A Study of the Effect of Oats on Post Prandial Glucose Response
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Randomized Controlled Cross-over Study of the Effect of Oats on Post Prandial Glucose Response
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 56 mmolL males and females 12 of each of age 18-45 y with a body mass index BMI of 185-299 kgm2 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 energyfatigue 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 bitesip 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
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 energyfatigue 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 bitesip 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None