Obesity Clinical Trial
— BGImagingOfficial title:
Developing Magnetic Resonance Imaging Techniques to Explore the Brain-gut Axis to Food Intake in People With Obesity and Healthy Weight Participants
NCT number | NCT05437653 |
Other study ID # | 19047 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 28, 2022 |
Est. completion date | December 30, 2023 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Nottingham | Nottingham |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Primary | Changes in Cerebral blood flow between drinks (Fat drink VS Carbohydrate drink) and across groups (Healthy weight VS Obese) | Cerebral blood flow differences | From baseline to up to 2 hours after ingesting the drinks | |
Primary | 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. | From baseline to up to 2 hours after ingesting the drinks | |
Primary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Primary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Secondary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Secondary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Secondary | 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 | From baseline to up to 2 hours after ingesting the drinks | |
Secondary | Correlations between blood, brain and gut and satiety date | Exploratory correlations between blood, brain and gut responses and satiety data | From baseline to up to 2 hours after ingesting the drinks |
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