Status:
UNKNOWN
MRI Based Study to Assess Brain-gut Axis in Obesity
Lead Sponsor:
University of Nottingham
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
NA
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 imagin...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05437653
Start Date
March 28 2022
End Date
December 30 2023
Last Update
June 29 2022
Active Locations (1)
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1
University of Nottingham
Nottingham, United Kingdom, NG7 2RD