Clinical Trials Directory

Trials / Completed

CompletedNCT02655367

The Effect of Oat Processing on Gastric Emptying and Satiety Induced After Consuming Porridge

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Quadram Institute Bioscience · Academic / Other
Sex
Male
Age
20 Years – 55 Years
Healthy volunteers
Accepted

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 (min.7 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 10.00pm 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.

Conditions

Interventions

TypeNameDescription
OTHERFlaked oatsTest meal consisting of 264g porridge made with flaked oats
OTHERMilled oatsTest meal consisting of 264g porridge made with milled oats

Timeline

Start date
2015-11-01
Primary completion
2016-05-01
Completion
2016-05-01
First posted
2016-01-14
Last updated
2016-09-02

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02655367. Inclusion in this directory is not an endorsement.