Back to resultsMRI Based Study to Assess Brain-gut Axis in Obesity (BGImaging)
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nutritional Drink A
Nutritional Drink B
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- University of NottinghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Obese group
Arm Description
Healthy weight group ( same age and sex)
Obese group
Outcomes
Primary Outcome Measures
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
Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Cerebral blood flow differences
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.
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
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
Secondary Outcome Measures
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
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
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
Correlations between blood, brain and gut and satiety date
Exploratory correlations between blood, brain and gut responses and satiety data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05437653
Brief Title
MRI Based Study to Assess Brain-gut Axis in Obesity
Acronym
BGImaging
Official Title
Developing Magnetic Resonance Imaging Techniques to Explore the Brain-gut Axis to Food Intake in People With Obesity and Healthy Weight Participants
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, cerebral blood flow, resting state fMRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
This is a double-blinded study, and the study participant and assessor will be unaware of the nature of the drink. Subjects will be invited into 2 MRI scan visits to investigate the brain and gut responses (brain-gut axis) to a high fat drink and a carbohydrate drink. Drinks will be randomised across participants using research randomizer software (https://www.randomizer.org/).
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Healthy weight group ( same age and sex)
Arm Title
Obese group
Arm Type
Active Comparator
Arm Description
Obese group
Intervention Type
Other
Intervention Name(s)
Nutritional Drink A
Intervention Description
300 mL of a 22% high fat emulsion (Rapeseed oil, water, emulsifier)
Intervention Type
Other
Intervention Name(s)
Nutritional Drink B
Intervention Description
300 mL of isocaloric, iso-volumetric and iso-viscous carbohydrate drink (maltodextrin)
Primary Outcome Measure Information:
Title
Changes in appetite- and satiety-related brain responses between drinks ( Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS obese)
Description
Blood oxygen level-dependent (BOLD) responses to high-calorie, low-calorie and non-food images
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Cerebral blood flow differences
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Changes resting state brain networks between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Alterations in functional brain connectivity/networks in brain regions involved in homeostatic and hedonic brain circuits.
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Changes in gastric volume between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Area Under the Curve of post-prandial gastric volumes, measured by MRI
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
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)
Description
Exploratory correlations between brain and gut responses
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Secondary Outcome Measure Information:
Title
Changes in small bowel water content between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Area Under the Curve of post-prandial small bowel water content, measured by MRI, up to 2h (AUC2h) postprandially
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Changes in satiety and appetite regulators between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Area Under the Curve of post-prandial serum gut hormone (CCK, GLP-1, PYY, Ghrelin), insulin, free fatty acid, glucose, and triglyceride concentrations
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Changes in satiety and appetite score (VAS) between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese)
Description
Area Under the Curve for appetite (Fullness, Hunger, Prospective food consumption) post prandial 100 mm VAS scores AUC2h
Time Frame
From baseline to up to 2 hours after ingesting the drinks
Title
Correlations between blood, brain and gut and satiety date
Description
Exploratory correlations between blood, brain and gut responses and satiety data
Time Frame
From baseline to up to 2 hours after ingesting the drinks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Eldeghaidy, PhD
Phone
0115 84 66003
Email
sally.eldeghaidy@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally Eldeghaidy, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2RD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally Eldeghaidy, PhD
Phone
0115 84 66003
Email
sally.eldeghaidy@nottingham.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
will be available upon reasonable request
Learn more about this trial
MRI Based Study to Assess Brain-gut Axis in Obesity
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