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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT06013592
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 18 and 60 years;
* Without obesity with body mass index (BMI) 18.0-29.9 kg/m2 or with obesity with BMI 30.0-50.0 kg/m2;
* Healthy as determined by medical history and vital signs;
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
* Participant is able to read, comprehend and record information written in English.
Exclusion Criteria:
* History of, or current abuse or dependence on alcohol or drugs;
* Current smoker or less than 2 years since quitting (cigarette, cigars, e-cigarettes) or use of nicotine replacement therapy;
* Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation;
* History of type 1 or type 2 diabetes mellitus;
* History of ischaemic heart disease, heart failure, cardiac arrhythmia, peripheral vascular, cerebrovascular disease or uncontrolled hypertension;
* Current diagnosis of anaemia or iron deficiency;
* Body weight instability (change in body weight of more than 5% over the preceding 3 months);
* Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures;
* Clinically significant abnormalities in screening blood tests abnormalities which in the opinion of the study physician, is clinically significant e.g. diabetes mellitus, hypothyroidism, renal impairment, abnormal liver function tests \[bilirubin, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT)\] \>3x upper limit of normal, other than due to fatty liver disease; Current pregnancy or breast-feeding in female volunteers (the Investigators will recommend using contraception for the duration of the visits to avoid participant drop-out);
* Pulse rate \<40 or \>100 beats per minute OR systolic blood pressure \>160 and \<100 OR diastolic blood pressure \>95 and \<50 in the semi-supine position;
* Volunteer has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
* Exposure to more than 3 new investigational medicinal products within 12 months prior to the scan;
* Vegan, gluten or lactose-intolerant (as test meals in the paradigms may include animal products, dairy and wheat products);
* Volunteers who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion;
* Known history of SARS-CoV-2 infection (Covid-19) in the last 4 weeks;
* Ongoing symptoms suggestive of complications from previous SARS-CoV-2 infection ('long Covid-19') such as loss or change in sense of smell or taste, shortness of breath, palpitations, lethargy;
* SCOFF questionnaire score \>1/5 indicating eating disorders (Luck et al. 2002);
* DSM-V criteria for alcohol use disorder (AUD) \>2/11 indicating mild AUD (American-Psychiatric-Association 2013);
* Participants who have had previous obesity surgery or are on medications for obesity;
* Dutch Eating Behaviour Questionnaire (DEBQ) restraint score \>3/5 indicating highly restrained eating behaviour.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06013592
Study Brief:
Protocol Section:
NCT06013592