Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-03-28
2023-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Control group
Healthy weight group ( same age and sex)
Nutritional Drink A
300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)
Nutritional Drink B
300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)
Obese group
Obese group
Nutritional Drink A
300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)
Nutritional Drink B
300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)
Interventions
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Nutritional Drink A
300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)
Nutritional Drink B
300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Sally Eldeghaidy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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University of Nottingham
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19047
Identifier Type: -
Identifier Source: org_study_id
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