Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04181957
Eligibility Criteria:
Inclusion Criteria:
* Fluent English speakers
* Be willing to be informed of chance pathological findings from the fMRI scan
* Must have binge-eating symptoms that is measured by a minimum score of 18 on the Binge Eating Scale
* Must have a minimum BMI of 18.5
* Must be below 152.4kg
* Must have clearance from a qualified physician before participating
Exclusion Criteria:
* Symptoms or diagnosis of other eating disorders.
* Psychotherapy and/or pharmacotherapy for binge-eating disorder (BED) 3 months before the study, as this will suggest a diagnosis of BED and may influence eating behaviour.
* Metabolic (e.g. metabolic disorder, diabetes), psychological (e.g. depression), substance, or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases
* Intake of any medication that can interfere with the drug or measurements, determined through questionnaires in the screening session
* Current smoking, as it can interfere with appetite
* Current pregnancy or breastfeeding
* Not passing a breathalyser test on the morning of testing.
* Food allergies (e.g. peanut allergy, lactose and gluten intolerance) or vegetarian/vegan diet
* Disliking the study lunch to ensure that participants will consume the provided food
* Women will be asked to participate only in weeks when they are not menstruating or in their pre-menstrual week, to avoid hormonal disruption to appetite.
The following are exclusion criteria are specific to the MRI scanner:
* Non-removable metal object in or on their body, such as: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
* Left-handed
* Tattoos that are older than 10 years
* Claustrophobia
* Limited temperature perception and/or increased sensitivity to warming of the body
* Pathological hearing ability or an increased sensitivity to loud noises
* Operation less than three months ago
* Simultaneous participation in other studies that involve drug intake or blood sampling
* Acute illness or infection during the last 4 weeks
* Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome) to ensure medical fitness to participate
* Moderate or severe head injury
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04181957
Study Brief:
Protocol Section:
NCT04181957