Metabolic SyndromeOatmetNCT02655367
The Effect of Oat Processing on Gastric Emptying and Satiety Induced After Consuming Porridge
A study testing Flaked oats and Milled oats in people with Metabolic Syndrome, run by Quadram Institute Bioscience at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Flaked oats and Milled oats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male (hormonal status of women would introduce more variation within small group)
- Age 20-55y (people older than the upper age limit for the study, may suffer from degeneration of the GI tract, which would compromise our study data).
- BMI 19-35 kg/m2
- Apparently healthy
- Normally eat lunch and breakfast
- Willing to eat porridge type meal
- Willing to be cannulated and have blood samples taken
- Be able provide written informed consent
Who cannot join
- Potential participants will be excluded if:
- They are line managed or supervised by any members of the study team either at IFR or NNUHFT Radiology.
- They are a student with a dependency on any member of the NNUHFT/ IFR study team.
- They are related to or living with any member of the study team (NNUHFT or IFR).
- They have an intense dislike of/ intolerance / allergy to any of the constituents of the test meal.
- They are smokers or have smoked within the last year (smoking affects satiety/hunger); this also includes e-cigarettes.
Show all 42Show fewer
- They have been diagnosed with any long term illness requiring active treatment e.g. diabetes, cancer, cardiovascular disease.
- They have had surgery on the stomach or intestine or suffered from oesophageal or gastrointestinal disease, whether diagnosed or self-reported.
- They currently suffer from, or have suffered from an eating disorder.
- They are taking antibiotics on a long-term basis.
- They regularly (more than once in 10 days) use antacids, laxatives.
- They have any problems with swallowing.
- They take prescribed or over the counter medication for digestive or gastrointestinal conditions.
- They are receiving anticoagulant therapy or have finished anticoagulant therapy within the previous week.
- They are taking any dietary supplements/ herbal remedies which may affect the study data unless they are willing to stop taking within the appropriate timescale for the study. These will be assessed on an individual basis.
- They are currently using Ginko supplements (unless the individual is willing to stop taking the supplements for a minimum of 1 week before screening and for the duration of the study).
- They are taking part in another research study (other than a questionnaire based study).
- Their blood pressure greater than 160/100 mmHg or less than 90/50 or 95/55 mmHg if symptomatic.
- They have any special dietary requirements (e.g. dairy-free).
- They have participated in a research study during the previous four months where the combined blood sampling from previous study and this study would exceed 470 ml.
- Any of the clinical screening results are indicative of a health problem which could affect the participants' well-being or which would affect the study data if they took part.
- The HbA1c result greater than 42 mmol/ ml.
- They are unwilling or unable to provide GP details.
- They refuse to give permission to inform GP of participation in study.
- They are not registered with a GP in the UK
- They have recently experienced unexplained weight gain or loss.
- They have a history of back problems or any other condition which limit ability to repeatedly sit up and lie down.
- They have a Hiatus Hernia.
- MRI scanning specific exclusion criteria:
- Potential participants will also be excluded from the study if they:
- Have a cardiac pacemaker or artificial heart valve.
- Have had any surgery in the last 6 months.
- Have aneurysm clips (metal clips from surgery).
- Have an implant, pump or any medical device in the body (e.g. cochlear implant, neurostimulator, intra-venticular shunt).
- Have worked with metals (using lathes or grinders) or sustained injury to eyes involving metal splinters or fillings.
- Have artificial eyes or limbs.
- Have been injured with shrapnel or bullets.
- Have a metal tattoo.
- Suffer from fits, blackouts or epilepsy.
- Suffer from claustrophobia.
- Clinical screening exclusion criteria:
- Potential participants will be excluded if clinical screening results deemed by the HNU Medical Advisor, to be indicative of a health problem which may compromise the well-being of the participant, or which could affect the study data.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Food Research
Norwich, Norfolk, NR4 7UA
About this study
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.
Read the 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
- Metabolic Syndrome
- Being tested
- Flaked oats, Milled oats
- Keywords
- MRI, oats, porridge, satiety, GI hormones, processing
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaked oatsOther
Test meal consisting of 264g porridge made with flaked oats
Milled oatsOther
Test meal consisting of 264g porridge made with milled oats
| Study group | Role | What they receive |
|---|---|---|
| Milled followed by flaked oats | Experimental | Participant consumes test meal consisting of porridge made from milled oats on study day 1, followed by porridge made from flaked oats on study day 2 Receives: Other: Flaked oats; Other: Milled oats |
| Flaked followed by milled oats | Experimental | Participant consumes test meal consisting of porridge made from flaked oats on study day 1, followed by porridge made from milled oats on study day 2 Receives: Other: Flaked oats; Other: Milled oats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of gastric content
Three dimensional MRI data will be used to determine the volume of gastric content at each time point and thus allow the calculation of gastric emptying rate
Measured: 3 hours
Secondary outcomes (1)
Satiety response
A visual analogue scale questionnaire will be used to assess satiety response at each time point.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Responsible party
- Sponsor
- Investigators
- Alan R Mackie, PhD, Principal investigator, Quadram Institute Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655367
- Sponsor's protocol ID
- IFR08/2014
- Acronym
- Oatmet
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oat Processing on Gastric Emptying and Satiety Induced After Consuming Porridge
- ClinicalTrials.gov ID
- NCT02655367
- Acronym / sponsor ID
- Oatmet / IFR08/2014
- Conditions
- Metabolic Syndrome
- Keywords
- MRI, oats, porridge, satiety, GI hormones, processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milled followed by flaked oats | Experimental | Other: Flaked oats, Other: Milled oatsParticipant consumes test meal consisting of porridge made from milled oats on study day 1, followed by porridge made from flaked oats on study day 2 |
| Flaked followed by milled oats | Experimental | Other: Flaked oats, Other: Milled oatsParticipant consumes test meal consisting of porridge made from flaked oats on study day 1, followed by porridge made from milled oats on study day 2 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male (hormonal status of women would introduce more variation within small group)
- Age 20-55y (people older than the upper age limit for the study, may suffer from degeneration of the GI tract, which would compromise our study data).
- BMI 19-35 kg/m2
- Apparently healthy
- Normally eat lunch and breakfast
Key exclusion criteria (42 listed)
- They are line managed or supervised by any members of the study team either at IFR or NNUHFT Radiology.
- They are a student with a dependency on any member of the NNUHFT/ IFR study team.
- They are related to or living with any member of the study team (NNUHFT or IFR).
- They have an intense dislike of/ intolerance / allergy to any of the constituents of the test meal.
- They are smokers or have smoked within the last year (smoking affects satiety/hunger); this also includes e-cigarettes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaked oatsTest meal consisting of 264g porridge made with flaked oats | Other | Flaked followed by milled oats, Milled followed by flaked oats |
| Milled oatsTest meal consisting of 264g porridge made with milled oats | Other | Flaked followed by milled oats, Milled followed by flaked oats |
Primary outcome
Volume of gastric content
Time frame: 3 hours
Three dimensional MRI data will be used to determine the volume of gastric content at each time point and thus allow the calculation of gastric emptying rate
1 secondary outcome
Satiety response
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan R Mackie, PhD principal investigator
Quadram Institute Bioscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaked oats and Milled oats in people with Metabolic Syndrome, run by Quadram Institute Bioscience at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of gastric content (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.