HealthyAMORENCT02653274
Assessment of Millet, Oat and Rye Porridge Breakfasts Glucose and Gastric Emptying
A study testing Breakfast porridge in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Breakfast porridges are made from milled grains and are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst millet is very common in parts of India and Africa. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breakfast porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
- Able to give informed consent
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician)
Who cannot join
- Use of medication which interferes with study measurements (as judged by the study physician).
- Participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- Not used to eating breakfast
- Not used to eating three meals a day
- Reported participation in night shift work during the two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
- Strenuous exercise for more than10 hours per week.
Show all 18Show fewer
- Consumption of ≥21 alcoholic drinks in a typical week
- Reported weight loss or gain ≥ 10 % of bodyweight during the six months period before the pre-study examination.
- Following a medically- or self-prescribed diet during the two weeks prior to the pre-study examination and until the end of the study
- Dislike of the products served as the dietary test treatments
- Any allergy or food intolerance to the test treatments
- An eating disorder as indicated by the Three factor eating questionnaire
- Not suitable for MRI scanning (e.g., presence of metal implants, infusion pumps and pacemakers) as assessed by standard MRI safety questionnaire.
- Pregnancy declared by candidate
- Antibiotic or prescribed probiotic treatment in the past 12 weeks
- Inability to lie flat
- Exceeding the scanner bed weight limit of120kg
- Poor understanding of the spoken and/or written English language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham Digestive Disases Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Gastrointestinal and Blood Glucose Responses to Breakfast Porridges Made From Different Grains: A Magnetic Resonance Imaging Pilot Study in Healthy Volunteers
Breakfast porridges are made from milled grains and are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst millet is very common in parts of India and Africa. However the nutritional value and potential metabolic and health effects may vary dramatically between different grains. For example what is the effect of the different grains on blood sugar or on how fast the stomach empties after eating the porridge and how full people feel. All these physiological responses may differ between these grains resulting in potential health benefits.
RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains will behave differently during the digestion and cause differences in blood glucose levels, gastric emptying and appetite.
Read more
This study, which is a 4-way, randomized, cross over pilot study in healthy participants, aims to answer this research question.
The participants will be asked to eat a porridge breakfasts made with oats, rye and millet of different varieties (but containing the same amount of calories), in 4 morning studies one week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and measure gastric emptying using MRI, blood glucose levels using a finger prick test and self-reported appetite scores.
Read the detailed description
Background: Porridge breakfasts from various grains are a staple source of energy for many populations worldwide. The grains used in the porridges differ between regions, mostly due to the crops historically grown. For example, oats are more common in the Anglo-Saxon countries; rye is traditional in the Scandinavian countries whilst millet is very common in parts of India and Africa. Porridge consumption is very popular: 78% of South Africans eat porridge; 49% of British people eat porridge with 23% doing so almost daily; 62% of U.S. households buy hot cereal breakfast and the hot cereal segment is the best performer within the breakfast cereals market in the UK. Consumption of whole grains has been associated with a variety of health benefits ranging from lower blood glucose levels, improved insulin responses, reduced cholesterol and increased diversity of the microbiota. Of particular interest to this study are recent suggestions that different grains, and particularly millet grains, may have enhanced health benefits on glucose and insulin metabolism. This may be due to different rates of digestion and absorption, for example, because of grain specific differences in starch digestibility. This could affect gastric emptying and, in turn, post prandial glycaemia and impact on satiety. However little is known about possible differences in gastric emptying between breakfast porridges from different grains and possible relationship with glucose, insulin and appetite.
The hypothesis underlying this study is that porridges made from different grains (such as oats, rye and different millets) will produce different postprandial glucose levels and that these will correlate with gastric emptying and appetite in healthy volunteer participants.
Aims: 1. to collect pilot data on postprandial glucose levels of isoenergetic breakfast porridges made from different grains, such as oats, rye and millets of different origin. 2. to collect initial pilot data on their gastric emptying and satiety. 3. to compare postprandial glucose levels, gastric emptying and satiety for the different treatments 4. to explore relationships between glucose levels, gastric emptying and satiety.
Experimental protocol and methods: 16 healthy volunteers will participate in this 4-way study. They will attend one morning for each study, with the studies separated by 1 week. Before the test meal, and after that approximately every 15 min for 1 hour and after that approximately every 20 minutes for 1 hour the level of glucose in their blood will be measured using the finger prick method, as diabetics commonly do to monitor their blood sugars. The participants will also be scanned at baseline, immediately after the test meal and then every hour for 2 hours postprandially. Subjects will be scanned on a research dedicated 1.5T MRI scanner. At baseline and every time the subjects provide a blood glucose sample the participants will be asked to rate their feelings of fullness, hunger and appetite on 100mm VAS scales.
The subject will be fed four isoenergetic breakfast porridges: Oat, Rye, Pearl (Bajra) millet and Finger (Ragi) millet porridge sourced from supermarkets or food shops. These will be cooked in water to avoid confounding factor with milk. The test breakfast will have 220 kcal.
Statistical power. This is only a pilot study.
- Conditions
- Healthy
- Being tested
- Breakfast porridge
- Keywords
- MRI, blood glucose, satiety, breakfast, porridge, grains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast porridgeOther
220 kcal breakfast porridge served with 240 mL glass of water
| Study group | Role | What they receive |
|---|---|---|
| OATS PORRIDGE | Active comparator | Oats breakfast porridge Receives: Other: Breakfast porridge |
| RYE PORRIDGE | Active comparator | Rye breakfast porridge Receives: Other: Breakfast porridge |
| FINGER (RAGI) MILLET PORRIDGE | Active comparator | Finger (ragi) millet breakfast porridge Receives: Other: Breakfast porridge |
| PEARL (BAJRA) MILLET PORRIDGE | Active comparator | Pearl (bajra) millet breakfast porridge Receives: Other: Breakfast porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Area Under the Curve of post prandial blood glucose, measured using finger prick method, up to 2h (AUC2h) postprandially
Measured: From baseline up to 2 hours postprandially
Secondary outcomes (1)
Gastric volumes
Area Under the Curve of post prandial gastric volumes, measured by MRI, up to 2h (AUC2h) postprandially
Measured: From baseline up to 2 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionMar 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 HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaber Alyami, MRes, Study director, Nottingham Digestive Diseases Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653274
- Sponsor's protocol ID
- F14072015 SoM SPMIC BMedSci
- Acronym
- AMORE
- Status last verified
- May 2016
- First submitted
- 6 Jan 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal and Blood Glucose Responses to Breakfast Porridges Made From Different Grains: A Magnetic Resonance Imaging Pilot Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02653274
- Acronym / sponsor ID
- AMORE / F14072015 SoM SPMIC BMedSci
- Conditions
- Healthy
- Keywords
- MRI, blood glucose, satiety, breakfast, porridge, grains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 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.
Breakfast porridges are made from milled grains and are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries; rye is favoured in the Scandinavian countries whilst millet is very common in parts of India and Africa. However the nutritional value and potential metabolic and health effects may vary dramatically between different grains. For example what is the effect of the different grains on blood sugar or on how fast the stomach empties after eating the porridge and how full people feel. All these physiological responses may differ between these grains resulting in potential health benefits.
RESEARCH QUESTION: The investigators hypothesise that porridges made from different grains will behave differently during the digestion and cause differences in blood glucose levels, gastric emptying and appetite.
This study, which is a 4-way, randomized, cross over pilot study in healthy participants, aims to answer this research question.
The participants will be asked to eat a porridge breakfasts made with oats, rye and millet of different varieties (but containing the same amount of calories), in 4 morning studies one week apart. MRI will be used to monitor the gastrointestinal fate of the breakfasts and measure gastric emptying using MRI, blood glucose levels using a finger prick test and self-reported appetite scores.
Detailed description
Background: Porridge breakfasts from various grains are a staple source of energy for many populations worldwide. The grains used in the porridges differ between regions, mostly due to the crops historically grown. For example, oats are more common in the Anglo-Saxon countries; rye is traditional in the Scandinavian countries whilst millet is very common in parts of India and Africa. Porridge consumption is very popular: 78% of South Africans eat porridge; 49% of British people eat porridge with 23% doing so almost daily; 62% of U.S. households buy hot cereal breakfast and the hot cereal segment is the best performer within the breakfast cereals market in the UK. Consumption of whole grains has been associated with a variety of health benefits ranging from lower blood glucose levels, improved insulin responses, reduced cholesterol and increased diversity of the microbiota. Of particular interest to this study are recent suggestions that different grains, and particularly millet grains, may have enhanced health benefits on glucose and insulin metabolism. This may be due to different rates of digestion and absorption, for example, because of grain specific differences in starch digestibility. This could affect gastric emptying and, in turn, post prandial glycaemia and impact on satiety. However little is known about possible differences in gastric emptying between breakfast porridges from different grains and possible relationship with glucose, insulin and appetite.
The hypothesis underlying this study is that porridges made from different grains (such as oats, rye and different millets) will produce different postprandial glucose levels and that these will correlate with gastric emptying and appetite in healthy volunteer participants.
Aims: 1. to collect pilot data on postprandial glucose levels of isoenergetic breakfast porridges made from different grains, such as oats, rye and millets of different origin. 2. to collect initial pilot data on their gastric emptying and satiety. 3. to compare postprandial glucose levels, gastric emptying and satiety for the different treatments 4. to explore relationships between glucose levels, gastric emptying and satiety.
Experimental protocol and methods: 16 healthy volunteers will participate in this 4-way study. They will attend one morning for each study, with the studies separated by 1 week. Before the test meal, and after that approximately every 15 min for 1 hour and after that approximately every 20 minutes for 1 hour the level of glucose in their blood will be measured using the finger prick method, as diabetics commonly do to monitor their blood sugars. The participants will also be scanned at baseline, immediately after the test meal and then every hour for 2 hours postprandially. Subjects will be scanned on a research dedicated 1.5T MRI scanner. At baseline and every time the subjects provide a blood glucose sample the participants will be asked to rate their feelings of fullness, hunger and appetite on 100mm VAS scales.
The subject will be fed four isoenergetic breakfast porridges: Oat, Rye, Pearl (Bajra) millet and Finger (Ragi) millet porridge sourced from supermarkets or food shops. These will be cooked in water to avoid confounding factor with milk. The test breakfast will have 220 kcal.
Statistical power. This is only a pilot study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OATS PORRIDGE | Active comparator | Other: Breakfast porridgeOats breakfast porridge |
| RYE PORRIDGE | Active comparator | Other: Breakfast porridgeRye breakfast porridge |
| FINGER (RAGI) MILLET PORRIDGE | Active comparator | Other: Breakfast porridgeFinger (ragi) millet breakfast porridge |
| PEARL (BAJRA) MILLET PORRIDGE | Active comparator | Other: Breakfast porridgePearl (bajra) millet breakfast porridge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
- Able to give informed consent
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician)
Key exclusion criteria (18 listed)
- Use of medication which interferes with study measurements (as judged by the study physician).
- Participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
- Not used to eating breakfast
- Not used to eating three meals a day
- Reported participation in night shift work during the two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
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 |
|---|---|---|
| Breakfast porridge220 kcal breakfast porridge served with 240 mL glass of water | Other | FINGER (RAGI) MILLET PORRIDGE, OATS PORRIDGE, PEARL (BAJRA) MILLET PORRIDGE, RYE PORRIDGE |
Primary outcome
Blood glucose level
Time frame: From baseline up to 2 hours postprandially
Area Under the Curve of post prandial blood glucose, measured using finger prick method, up to 2h (AUC2h) postprandially
1 secondary outcome
Gastric volumes
Time frame: From baseline up to 2 hours postprandially
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 27 May 2016.
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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.
Jaber Alyami, MRes study director
Nottingham Digestive Diseases Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast porridge in people with Healthy, run by University of Nottingham 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 4 inclusion and 18 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 27 May 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?
Blood glucose level (time frame: From baseline up to 2 hours postprandially). 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 27 May 2016.