Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02655367
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2016-01-12
Brief Title:
The Effect of Oat Processing on Gastric Emptying and Satiety Induced After Consuming Porridge
Sponsor:
Quadram Institute Bioscience
Organization:
Quadram Institute Bioscience
Study Overview
Official Title:
The Effect of Oat Processing on Gastric Emptying and Satiety Induced After Consuming Porridge
Status:
COMPLETED
Status Verified Date:
2016-01
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:
Oatmet
Brief Summary:
This crossover study is designed to compare the gastric layering and rates of emptying and by inference rates of digestion of two different porridge meals prepared from either finely milled or flaked oats On each of two study days a total of 9 MRI scans will be taken I baseline and 8 post meal to assess gastric layering and emptying over three hours Blood samples will also be taken periodically over the same period in order to determine changes in concentrations of circulating glucose insulin and key gastrointestinal hormones Participants will also be asked to complete a questionnaire at predetermined times to assess feelings of satiation
Detailed Description:
Eight participants will be recruited onto the study via the Human Nutrition Unit HNU Volunteer Database advertising fliers and social media Potential participants will be invited to IFR for a talk about the study followed by health screening if they wish to participate Written informed consent will be taken by a member of the research team prior to undertaking any study related procedures
Each participant will undergo 2 study days min7 days apart and they will eat 2 types of porridge in a random order Allocation of the order of the porridge meals will be done before the participants are recruited onto the study using an online randomizer On one occasion participants will consume porridge made from milled oats and on the other occasion porridge made from flaked oats Participants will undergo 9 MRI scans of the stomach over a 3h post ingestion period and after each scan a 4 ml blood sample will be collected via an intravenous cannula Feelings of satiety will be assessed using a short VAS questionnaire at 9 intervals during the study day
Study day participants will not be able to eat any food after 1000pm on the evening prior to each study day but they will be allowed water until they go to bed Participants will be asked to record what they have eaten on the evening prior to study day 1 and they will be asked to eat the same foods on the evening before the second study day Participants must not consume any breakfast on the morning of the study day but they can drink up until 7 am The study day will start at 9 am at the Radiology Department at the Norfolk and Norwich University Hospital After cannulation and blood sampling initial baseline MRI scans and VAS questionnaires the participants will eat the allocated porridge 264 g and drink the water provided 175 ml They will then undergo 8 more MRI scans have blood taken 8 more times and complete 8 satiety questionnaires at specific time points
After completion of all MRI scans blood sampling and satiety questionnaires participants will be provided with a 500 ml bottle of water and a packed lunch
Each participant will undergo 2 study days min7 days apart and they will eat 2 types of porridge in a random order Allocation of the order of the porridge meals will be done before the participants are recruited onto the study using an online randomizer On one occasion participants will consume porridge made from milled oats and on the other occasion porridge made from flaked oats Participants will undergo 9 MRI scans of the stomach over a 3h post ingestion period and after each scan a 4 ml blood sample will be collected via an intravenous cannula Feelings of satiety will be assessed using a short VAS questionnaire at 9 intervals during the study day
Study day participants will not be able to eat any food after 1000pm on the evening prior to each study day but they will be allowed water until they go to bed Participants will be asked to record what they have eaten on the evening prior to study day 1 and they will be asked to eat the same foods on the evening before the second study day Participants must not consume any breakfast on the morning of the study day but they can drink up until 7 am The study day will start at 9 am at the Radiology Department at the Norfolk and Norwich University Hospital After cannulation and blood sampling initial baseline MRI scans and VAS questionnaires the participants will eat the allocated porridge 264 g and drink the water provided 175 ml They will then undergo 8 more MRI scans have blood taken 8 more times and complete 8 satiety questionnaires at specific time points
After completion of all MRI scans blood sampling and satiety questionnaires participants will be provided with a 500 ml bottle of water and a packed lunch
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