Last updated: June 23, 2022
Sponsor: University of Nottingham
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Prevention
Obesity
Treatment
N/AClinical Study ID
NCT05437653
19047
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged 18-45, male and female (females will have the study days arranged during theearly phase of the menstrual cycle).
- Body mass index (BMI): normal weight participants ≥ 19 and ≤ 25 Kg/m2, and obeseparticipants > 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
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 ofmetallic foreign body in eye(s) and penetrating eye injury, assessed by standard MRIsafety questionnaire.
- Under medication (expect aspirin/paracetamol), antibiotic or prescribed probiotictreatment in the past 12 weeks.
- Following a medically- or self-prescribed diet during the two weeks prior to thepre-study examination and until the end of the study.
- Reported weight loss or gain ≥ 10 % of bodyweight during the six months period beforethe pre-study examination
- Pregnancy or breastfeeding declared by candidate
- Smoking
- Left-handed assessed by handedness questionnaire. This is to control for brain'slateralisation effects (activation in one side of the brain) that may show variationsbetween left and right handed participants.
- Participation in another clinical or research study within the previous 3 months ofthe study
- Cannot lie flat or exceeding the scanner bed weight limit of 250 kg.
- Poor understanding of the spoken and/or written English language
Study Design
Total Participants: 40
Study Start date:
March 28, 2022
Estimated Completion Date:
December 30, 2023
Study Description
Connect with a study center
University of Nottingham
Nottingham, NG7 2RD
United KingdomActive - Recruiting
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