Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04260425
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2020-02-05
Brief Title:
A Pilot Study Evaluating Oat Polyphenols on Post-prandial Glucose Response
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
A Randomized Controlled Pilot Study Evaluating the Effect of Oat Polyphenols on Post-prandial Glucose Response in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-09
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 trial will use a two period acute double-blind cross-over design to compare the effects of a serving of oatmeal containing high or low amounts of avenanthramides AV on post-prandial blood glucose response in healthy adults
Detailed Description:
The clinical trial will follow a two period acute double-blind cross-over design It will take place at Richardson Centre for Functional Food and Nutraceuticals RCFFN at University of Manitoba Winnipeg Canada
The trial will recruit healthy adult participants Participants will consent to participate in two acute feeding sessions Participants will be randomized to either control low avenanthramides then treatment high avenanthramides or treatment then control Participants will arrive at the study center fasted between 8 and 1030 am on the session days They will be provided either the study treatment or control product based on randomization sequence for their first study visit Baseline blood glucose 0 min will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product and at 15 30 45 60 90 and 120 mins after baseline The timer will be started when they take their first bite During the second visit participant will consume the other treatment based on the randomization the oatmeal that they didnt receive in their first visit and follow exactly the same procedure as the first visit There will be a minimum of 5 days between sessions Female participants will be scheduled during the luteal phase of their menstruation cycle There will be a maximum of 8 weeks between the two sessions therefore participants will finish the both sessions within an 8 week period
The trial will recruit healthy adult participants Participants will consent to participate in two acute feeding sessions Participants will be randomized to either control low avenanthramides then treatment high avenanthramides or treatment then control Participants will arrive at the study center fasted between 8 and 1030 am on the session days They will be provided either the study treatment or control product based on randomization sequence for their first study visit Baseline blood glucose 0 min will be measured in duplicate via finger stick blood sample right before their first bite of the treatment product and at 15 30 45 60 90 and 120 mins after baseline The timer will be started when they take their first bite During the second visit participant will consume the other treatment based on the randomization the oatmeal that they didnt receive in their first visit and follow exactly the same procedure as the first visit There will be a minimum of 5 days between sessions Female participants will be scheduled during the luteal phase of their menstruation cycle There will be a maximum of 8 weeks between the two sessions therefore participants will finish the both sessions within an 8 week period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None