ObesityBGImagingNCT05437653
MRI Based Study to Assess Brain-gut Axis in Obesity
A study testing Nutritional Drink A and Nutritional Drink B in people with Obesity, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The mechanism of neural communication between the brain and gut in the regulation of food intake is complex and not fully understood. Magnetic Resonance Imaging (MRI) is a powerful non-invasive imaging tool that allows studying the function of the brain and gut. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutritional Drink A and Nutritional Drink B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 30 Dec 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-45, male and female (females will have the study days arranged during the early phase of the menstrual cycle).
- Body mass index (BMI): normal weight participants ≥ 19 and ≤ 25 Kg/m2, and obese participants > 30 Kg/m2
- Able to give voluntary written informed consent to participate in the study
- Able to understand the requirements of the study
- Apparently healthy: no medical conditions which might affect study measurements (judged by health questionnaire, and blood screening)
Who cannot join
- Any reported history of neurological or gastrointestinal disorders
- Any reported history of surgery that could affect gastrointestinal function (e.g. colectomy, small bowel resection)
- Abnormal screening procedures including depression and eat restriction
- Laboratory results that are clinically significant, including diabetes, dyslipidemia, pancreatitis, or untreated hypertension.
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, assessed by standard MRI safety questionnaire.
- Under medication (expect aspirin/paracetamol), antibiotic or prescribed probiotic treatment in the past 12 weeks.
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- Following a medically- or self-prescribed diet during the two weeks prior to the pre-study examination and until the end of the study.
- Reported weight loss or gain ≥ 10 % of bodyweight during the six months period before the pre-study examination
- Pregnancy or breastfeeding declared by candidate
- Smoking
- Left-handed assessed by handedness questionnaire. This is to control for brain's lateralisation effects (activation in one side of the brain) that may show variations between left and right handed participants.
- Participation in another clinical or research study within the previous 3 months of the study
- Cannot lie flat or exceeding the scanner bed weight limit of 250 kg.
- Poor understanding of the spoken and/or written English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Magnetic Resonance Imaging Techniques to Explore the Brain-gut Axis to Food Intake in People With Obesity and Healthy Weight Participants
The mechanism of neural communication between the brain and gut in the regulation of food intake is complex and not fully understood. Magnetic Resonance Imaging (MRI) is a powerful non-invasive imaging tool that allows studying the function of the brain and gut. The aim of this study is to develop MRI methods to combine brain and gut imaging in a single MRI scan session. The developed techniques will then be used to assess the brain-gut axis to a high fat drink compared with iso-caloric/iso-viscous/iso-volumetric carbohydrate drink in people with obesity and healthy weight participants. The findings could provide a possible explanation for why some people are heavier than others.
Read the detailed description
20 healthy weight participant (18 Kg/m2>BMI<30Kg/m2) and 20 age- and sex- matched peoples with obesity (BMI >30 Kg/m2) will be invited to a double-blinded two-way crossover MRI study, approximately 1 week apart, to assess the interplay between brain and gut to food intake.
Brain and gut MRI scans will be collected at fasted/baseline and at different time points postprandial for 120 mins using the 3T Ingenia Philips scanner. Brain measurements including resting state-fMRI, cerebral blood flow (CBF), and task-fMRI scans will be collected. During the task fMRI scan, images of high and low energy food pictures, and non-food control pictures will be presented. Food images are extensively used in fMRI studies to characterise the neural systems involved in processing the hedonic value of food as well as satiety and hunger signals. In addition to brain scans, sequences of gut scans will be collected to assess gastric volume, small bowel water content, and superior mesenteric artery (SMA) responses pre- and post-prandial. Blood samples will be collected to assess gut hormones (CCK, GLP1- PYY, ghrelin) insulin and glucose, triglycerides, free fatty acid levels at different timepoints. In addition, satiety and appetite scores will be collected using visual analogue scales. The total scan time including the fed and break times is around 3 hours.
- Conditions
- Obesity
- Being tested
- Nutritional Drink A, Nutritional Drink B
- Keywords
- obesity, brain-gut axis, functional magnetic resonance imaging, gastric emptying, small bowel water content, high fat meal, carbohydrate meal, Blood-oxygen-level-dependent, cerebral blood flow, resting state fMRI
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Drink AOther
300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)
Nutritional Drink BOther
300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Healthy weight group ( same age and sex) Receives: Other: Nutritional Drink A; Other: Nutritional Drink B |
| Obese group | Active comparator | Obese group Receives: Other: Nutritional Drink A; Other: Nutritional Drink B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in appetite- and satiety-related brain responses between drinks ( Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS obese)
Blood oxygen level-dependent (BOLD) responses to high-calorie, low-calorie and non-food images
Measured: From baseline to up to 2 hours after ingesting the drinks
Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Cerebral blood flow differences
Measured: From baseline to up to 2 hours after ingesting the drinks
Changes resting state brain networks between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Alterations in functional brain connectivity/networks in brain regions involved in homeostatic and hedonic brain circuits.
Measured: From baseline to up to 2 hours after ingesting the drinks
Changes in gastric volume between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Area Under the Curve of post-prandial gastric volumes, measured by MRI
Measured: From baseline to up to 2 hours after ingesting the drinks
Correlations between gut and brain responses to assess alterations in brain-gut axis between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Exploratory correlations between brain and gut responses
Measured: From baseline to up to 2 hours after ingesting the drinks
Secondary outcomes (4)
Changes in small bowel water content between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Area Under the Curve of post-prandial small bowel water content, measured by MRI, up to 2h (AUC2h) postprandially
Measured: From baseline to up to 2 hours after ingesting the drinks
Changes in satiety and appetite regulators between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Area Under the Curve of post-prandial serum gut hormone (CCK, GLP-1, PYY, Ghrelin), insulin, free fatty acid, glucose, and triglyceride concentrations
Measured: From baseline to up to 2 hours after ingesting the drinks
Changes in satiety and appetite score (VAS) between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Area Under the Curve for appetite (Fullness, Hunger, Prospective food consumption) post prandial 100 mm VAS scores AUC2h
Measured: From baseline to up to 2 hours after ingesting the drinks
Correlations between blood, brain and gut and satiety date
Exploratory correlations between blood, brain and gut responses and satiety data
Measured: From baseline to up to 2 hours after ingesting the drinks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start28 Mar 2022
- Primary completion1 Apr 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Model description
- Randomised parallel trial in human volunteers. Control (normal weight) group VS Obese group and High fat drink VS iso-caloric, iso-viscous Carbohydrate drink
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Eldeghaidy, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437653
- Sponsor's protocol ID
- 19047
- Acronym
- BGImaging
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Magnetic Resonance Imaging Techniques to Explore the Brain-gut Axis to Food Intake in People With Obesity and Healthy Weight Participants
- ClinicalTrials.gov ID
- NCT05437653
- Acronym / sponsor ID
- BGImaging / 19047
- Conditions
- Obesity
- Keywords
- obesity, brain-gut axis, functional magnetic resonance imaging, gastric emptying, small bowel water content, high fat meal, carbohydrate meal, Blood-oxygen-level-dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 29 Jun 2022 (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.
The mechanism of neural communication between the brain and gut in the regulation of food intake is complex and not fully understood. Magnetic Resonance Imaging (MRI) is a powerful non-invasive imaging tool that allows studying the function of the brain and gut. The aim of this study is to develop MRI methods to combine brain and gut imaging in a single MRI scan session. The developed techniques will then be used to assess the brain-gut axis to a high fat drink compared with iso-caloric/iso-viscous/iso-volumetric carbohydrate drink in people with obesity and healthy weight participants. The findings could provide a possible explanation for why some people are heavier than others.
Detailed description
20 healthy weight participant (18 Kg/m2>BMI<30Kg/m2) and 20 age- and sex- matched peoples with obesity (BMI >30 Kg/m2) will be invited to a double-blinded two-way crossover MRI study, approximately 1 week apart, to assess the interplay between brain and gut to food intake.
Brain and gut MRI scans will be collected at fasted/baseline and at different time points postprandial for 120 mins using the 3T Ingenia Philips scanner. Brain measurements including resting state-fMRI, cerebral blood flow (CBF), and task-fMRI scans will be collected. During the task fMRI scan, images of high and low energy food pictures, and non-food control pictures will be presented. Food images are extensively used in fMRI studies to characterise the neural systems involved in processing the hedonic value of food as well as satiety and hunger signals. In addition to brain scans, sequences of gut scans will be collected to assess gastric volume, small bowel water content, and superior mesenteric artery (SMA) responses pre- and post-prandial. Blood samples will be collected to assess gut hormones (CCK, GLP1- PYY, ghrelin) insulin and glucose, triglycerides, free fatty acid levels at different timepoints. In addition, satiety and appetite scores will be collected using visual analogue scales. The total scan time including the fed and break times is around 3 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised parallel trial in human volunteers. Control (normal weight) group VS Obese group and High fat drink VS iso-caloric, iso-viscous Carbohydrate drink
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Nutritional Drink A, Other: Nutritional Drink BHealthy weight group ( same age and sex) |
| Obese group | Active comparator | Other: Nutritional Drink A, Other: Nutritional Drink BObese group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-45, male and female (females will have the study days arranged during the early phase of the menstrual cycle).
- Body mass index (BMI): normal weight participants ≥ 19 and ≤ 25 Kg/m2, and obese participants > 30 Kg/m2
- Able to give voluntary written informed consent to participate in the study
- Able to understand the requirements of the study
- Apparently healthy: no medical conditions which might affect study measurements (judged by health questionnaire, and blood screening)
Key exclusion criteria (14 listed)
- Any reported history of neurological or gastrointestinal disorders
- Any reported history of surgery that could affect gastrointestinal function (e.g. colectomy, small bowel resection)
- Abnormal screening procedures including depression and eat restriction
- Laboratory results that are clinically significant, including diabetes, dyslipidemia, pancreatitis, or untreated hypertension.
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury, assessed by standard MRI safety questionnaire.
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 |
|---|---|---|
| Nutritional Drink A300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier) | Other | Control group, Obese group |
| Nutritional Drink B300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin) | Other | Control group, Obese group |
Primary outcome
Changes in appetite- and satiety-related brain responses between drinks ( Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Blood oxygen level-dependent (BOLD) responses to high-calorie, low-calorie and non-food images
Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Cerebral blood flow differences
Changes resting state brain networks between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Alterations in functional brain connectivity/networks in brain regions involved in homeostatic and hedonic brain circuits.
Changes in gastric volume between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Area Under the Curve of post-prandial gastric volumes, measured by MRI
Correlations between gut and brain responses to assess alterations in brain-gut axis between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Exploratory correlations between brain and gut responses
4 secondary outcomes
Changes in small bowel water content between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Changes in satiety and appetite regulators between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Changes in satiety and appetite score (VAS) between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Time frame: From baseline to up to 2 hours after ingesting the drinks
Correlations between blood, brain and gut and satiety date
Time frame: From baseline to up to 2 hours after ingesting the drinks
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 Jun 2026.
- Individual participant dataSharing planned: No. will be available upon reasonable request
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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.
Sally Eldeghaidy, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Drink A and Nutritional Drink B in people with Obesity, 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 5 inclusion and 14 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 Jun 2026. 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?
Changes in appetite- and satiety-related brain responses between drinks ( Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS obese) (time frame: From baseline to up to 2 hours after ingesting the drinks). The study lists 5 primary outcomes in all. 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 Jun 2026.