HealthyMOMNCT03068039
Millets and Oats MRI
A study testing Oats breakfast porridge and Pearl (bajra) breakfast porridge in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon 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?
- Oats breakfast porridge and Pearl (bajra) breakfast porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2016to 1 May 2017
- 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) ≥ 18.5 and ≤ 24.9 kg/m2
- Able to give informed consent
- Apparently healthy: no medical conditions which might affect study measurements (judged by the investigators)
Who cannot join
- Restrained eating behaviour as determined by Eating habits and SCOFF screening questionnaires
- Not used to eating breakfast
- Not used to eating three meals a day
- 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.
- 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.
Show all 19Show fewer
- Strenuous exercise for more than10 hours per week.
- 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
- 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
- Not willing to eat a pasta meal
- Exceeding the scanner bed weight limit of 120kg
- 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 , University of Nottingham
Nottingham, NG7 2UH
About this study
Official title: Gastrointestinal Responses to Millet and Oats Breakfast Interventions Assessed by MRI
Breakfast porridges made from milled grains are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the nutritional value of different grains and their potential effects on the body may vary dramatically: for example the effect on blood sugar, on how fast the stomach empties after eating and how full people may feel.
RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories. The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel. Blood glucose levels will be measured using a finger prick test (the same as used by diabetics) and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones.
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 whilst millet is very common in parts of India and Africa. 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 research group in Nottingham has world-leading expertise in imaging foods in the body and gastrointestinal function using non-invasive Magnetic Resonance Imaging (MRI) techniques which are particularly well suited for this kind of investigations study.
Aims:
- to collect data on postprandial glucose levels and hormone peptide response of isoenergetic breakfast porridges made from oats and pearl millet.
- to collect data on their gastric emptying and satiety.
- to compare postprandial glucose levels, gastric emptying and satiety for the treatments 4. to explore relationships between glucose levels, gastric emptying and satiety.
Experimental protocol and methods: 26 healthy volunteers will participate in this 2-way study. They will attend one morning for each study, with the studies separated by approximately a week. Before the test meal, and after that approximately every 15 min for 2 hours the level of sugar (glucose) in their blood will be measured using the finger prick method, as diabetics commonly do to monitor their blood sugars. Venous blood samples will also be collected from a cannula placed in the forearm to measure gut hormones such as Peptide YY, GIP, GLP-1 and insulin. The subjects will be scanned on a research dedicated 1.5T MRI scanner. The subjects will be scanned at baseline, immediately after the test meal and then every 30 minutes for 2 hours postprandially. At baseline and every time the subjects come out of the MRI scanner they will be asaked to rate their feelings of fullness, hunger and appetite on 100mm VAS scales. Each subject will be fed two isoenergetic breakfast meals -one on each visit: Oat and Pearl millet breakfast porridge sourced from supermarkets or food manufacturers. These will be cooked in water to avoid confounding factor with milk. The test breakfast will have 220 kcal (slightly higher than a commonly recommended average portion of ~185 kcal). After this the subjects will be asked to eat as much of a pasta meal as they wish and note how much they have eaten as an objective measure of food consumption. The subjects will also complete a food diary for the rest of the day.
Measurable endpoints/ statistical power Primary endpoint: Incremental Area Under the Curve of post prandial blood glucose up to 2h (AUC2h) Secondary endpoints: Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h), postprandial hormone peptide response, insulin and post prandial VAS scores up to 2h.
Descriptive and exploratory measurements: Time to Peak of blood glucose; Area Under the Curve for appetite (Fullness, Hunger, Prospective food consumption) up to 2h. The amount of pasta meal eaten ad libitum. Energy intake for the day from food diaries.
Correlations between blood, MRI and satiety data. Using Satiety data (Hunger) from our pilot study, we can calculate sample size needed using a crossover, paired design with alpha=0.05 and a power of 80% using n=26 participants.
The data will be assessed for normality using the Shapiro-Wilk test and other such methods as appropriate. Where normally distributed, endpoints will be assessed using parametric methods.
T test (primary endpoint) and AUC2h (secondary endpoints). T test of Time to Peak. Correlation (Pearson's or Spearman) between blood glucose, MRI and satiety data.
- Conditions
- Healthy
- Being tested
- Oats breakfast porridge, Pearl (bajra) breakfast porridge
- Keywords
- MRI, blood glucose, porridge, breakfast, satiety, plasma peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oats breakfast porridgeOther
Isoenergetic and isovolumteric oats breakfast porridge
Pearl (bajra) breakfast porridgeOther
Isoenergetic and isovolumteric pearl (bajra) breakfast porridge
| Study group | Role | What they receive |
|---|---|---|
| OATS PORRIDGE | Active comparator | Oats breakfast porridge 220 kcal served with 240 mL water Receives: Other: Oats breakfast porridge |
| PEARL (BAJRA) MILLET PORRIDGE | Active comparator | Pearl (bajra) millet breakfast porridge isoenergetic (220 kcal) served with 300 mL water to make it also isovolumteric with the Oats arm Receives: Other: Pearl (bajra) breakfast porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Incremental Area Under the Curve of post prandial blood glucose up to 2h (AUC2h) measured using finger prick method.
Measured: From baseline up to 2 hours postprandially
Secondary outcomes (3)
Gastric volumes
Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h).
Measured: From baseline up to 2 hours postprandially
Hormone peptide response and insulin
Area Under the Curve of post prandial hormone peptide response and insulin
Measured: From baseline up to 2 hours postprandially
appetite ratings VAS scores
Area Under the Curve for appetite (Fullness, Hunger, Prospective food consumption) up to 2h.
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 posted1 Mar 2017
- Study start25 Oct 2016
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 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 Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UHLuca Marciani, Principal investigator, Nottingham Digestive Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UHMoira Taylor, Principal investigator, School of Life Sciences, University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UHPenny A Gowland, Principal investigator, Sir Peter Mansfield Imaging Centre, University of Nottingham, Nottingham NG7 2RD, U.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068039
- Sponsor's protocol ID
- F12072016
- Acronym
- MOM
- Status last verified
- Oct 2017
- First submitted
- 24 Feb 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share IPD
Publications
Alyami J, Whitehouse E, Yakubov GE, Pritchard SE, Hoad CL, Blackshaw E, Heissam K, Cordon SM, Bligh HFJ, Spiller RC, Macdonald IA, Aithal GP, Gowland PA, Taylor MA, Marciani L. Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans. Br J Nutr. 2019 Nov 28;122(10):1142-1154. doi: 10.1017/S0007114519001880.
PubMed 31709970
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Responses to Millet and Oats Breakfast Interventions Assessed by MRI
- ClinicalTrials.gov ID
- NCT03068039
- Acronym / sponsor ID
- MOM / F12072016
- Conditions
- Healthy
- Keywords
- MRI, blood glucose, porridge, breakfast, satiety, plasma peptides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- 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 made from milled grains are commonly eaten worldwide. Traditionally different grains are used in different countries. For example, oats are more common in the Anglo-Saxon countries whilst millet is very common in parts of India and Africa. However the nutritional value of different grains and their potential effects on the body may vary dramatically: for example the effect on blood sugar, on how fast the stomach empties after eating and how full people may feel.
RESEARCH QUESTION: The investigators think that a pearl millet breakfast will cause a smaller rise in blood sugar compared with an oat breakfast containing the same number of calories. The investigators also think that there will be a difference in how full people feel and how fast their stomach will empty. These 2 breakfasts will be fed to each one of 26 healthy volunteers, one week apart. A safe medical imaging method (MRI) will be used to look at how quickly the breakfast empty from the stomach and how this affects the small bowel. Blood glucose levels will be measured using a finger prick test (the same as used by diabetics) and some small blood samples will be taken from a vein in the arm to measure the chemicals released by the gut after feeding gut hormones.
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 whilst millet is very common in parts of India and Africa. 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 research group in Nottingham has world-leading expertise in imaging foods in the body and gastrointestinal function using non-invasive Magnetic Resonance Imaging (MRI) techniques which are particularly well suited for this kind of investigations study.
Aims:
- to collect data on postprandial glucose levels and hormone peptide response of isoenergetic breakfast porridges made from oats and pearl millet.
- to collect data on their gastric emptying and satiety.
- to compare postprandial glucose levels, gastric emptying and satiety for the treatments 4. to explore relationships between glucose levels, gastric emptying and satiety.
Experimental protocol and methods: 26 healthy volunteers will participate in this 2-way study. They will attend one morning for each study, with the studies separated by approximately a week. Before the test meal, and after that approximately every 15 min for 2 hours the level of sugar (glucose) in their blood will be measured using the finger prick method, as diabetics commonly do to monitor their blood sugars. Venous blood samples will also be collected from a cannula placed in the forearm to measure gut hormones such as Peptide YY, GIP, GLP-1 and insulin. The subjects will be scanned on a research dedicated 1.5T MRI scanner. The subjects will be scanned at baseline, immediately after the test meal and then every 30 minutes for 2 hours postprandially. At baseline and every time the subjects come out of the MRI scanner they will be asaked to rate their feelings of fullness, hunger and appetite on 100mm VAS scales. Each subject will be fed two isoenergetic breakfast meals -one on each visit: Oat and Pearl millet breakfast porridge sourced from supermarkets or food manufacturers. These will be cooked in water to avoid confounding factor with milk. The test breakfast will have 220 kcal (slightly higher than a commonly recommended average portion of ~185 kcal). After this the subjects will be asked to eat as much of a pasta meal as they wish and note how much they have eaten as an objective measure of food consumption. The subjects will also complete a food diary for the rest of the day.
Measurable endpoints/ statistical power Primary endpoint: Incremental Area Under the Curve of post prandial blood glucose up to 2h (AUC2h) Secondary endpoints: Area Under the Curve of post prandial gastric volumes up to 2h (AUC2h), postprandial hormone peptide response, insulin and post prandial VAS scores up to 2h.
Descriptive and exploratory measurements: Time to Peak of blood glucose; Area Under the Curve for appetite (Fullness, Hunger, Prospective food consumption) up to 2h. The amount of pasta meal eaten ad libitum. Energy intake for the day from food diaries.
Correlations between blood, MRI and satiety data. Using Satiety data (Hunger) from our pilot study, we can calculate sample size needed using a crossover, paired design with alpha=0.05 and a power of 80% using n=26 participants.
The data will be assessed for normality using the Shapiro-Wilk test and other such methods as appropriate. Where normally distributed, endpoints will be assessed using parametric methods.
T test (primary endpoint) and AUC2h (secondary endpoints). T test of Time to Peak. Correlation (Pearson's or Spearman) between blood glucose, MRI and satiety data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OATS PORRIDGE | Active comparator | Other: Oats breakfast porridgeOats breakfast porridge 220 kcal served with 240 mL water |
| PEARL (BAJRA) MILLET PORRIDGE | Active comparator | Other: Pearl (bajra) breakfast porridgePearl (bajra) millet breakfast porridge isoenergetic (220 kcal) served with 300 mL water to make it also isovolumteric with the Oats arm |
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) ≥ 18.5 and ≤ 24.9 kg/m2
- Able to give informed consent
- Apparently healthy: no medical conditions which might affect study measurements (judged by the investigators)
Key exclusion criteria (19 listed)
- Restrained eating behaviour as determined by Eating habits and SCOFF screening questionnaires
- Not used to eating breakfast
- Not used to eating three meals a day
- 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.
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 |
|---|---|---|
| Oats breakfast porridgeIsoenergetic and isovolumteric oats breakfast porridge | Other | OATS PORRIDGE |
| Pearl (bajra) breakfast porridgeIsoenergetic and isovolumteric pearl (bajra) breakfast porridge | Other | PEARL (BAJRA) MILLET PORRIDGE |
Primary outcome
Blood glucose level
Time frame: From baseline up to 2 hours postprandially
Incremental Area Under the Curve of post prandial blood glucose up to 2h (AUC2h) measured using finger prick method.
3 secondary outcomes
Gastric volumes
Time frame: From baseline up to 2 hours postprandially
Hormone peptide response and insulin
Time frame: From baseline up to 2 hours postprandially
appetite ratings VAS scores
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 13 Oct 2017.
- Derived from this study: PubMed 31709970Alyami J, Whitehouse E, Yakubov GE, Pritchard SE, Hoad CL, Blackshaw E, Heissam K, Cordon SM, Bligh HFJ, Spiller RC, Macdonald IA, Aithal GP, Gowland PA, Taylor MA, Marciani L. Glycaemic, gastrointestinal, hormonal and appetitive responses to pearl millet or oats porridge breakfasts: a randomised, crossover trial in healthy humans. Br J Nutr. 2019 Nov 28;122(10):1142-1154. doi: 10.1017/S0007114519001880.
- Individual participant dataSharing planned: No. No plans to share IPD
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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 Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Luca Marciani principal investigator
Nottingham Digestive Disases Centre , University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Moira Taylor principal investigator
School of Life Sciences, University of Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oats breakfast porridge and Pearl (bajra) 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 19 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 13 Oct 2017. 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?
On the ClinicalTrials.gov record for NCT03068039, which also lists 1 linked publication.
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 13 Oct 2017.