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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT06849050
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18.5 - 24.9 kg/m2 and a waist circumference of ≤ 88 cm for women, and ≤ 102 cm for men or a BMI between 25 - 40 kg/m2 and a waist circumference of \> 88 cm for women, and \> 102 cm for men. BMI and waist circumference thresholds vary amongst ethnicities. People with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family background are prone to central adiposity and their cardiometabolic risk occurs at a lower BMI. Therefore, the following BMI and waist circumference thresholds will be applied for people of South Asian, other Asian, Black African and African-Caribbean ethnicity: (1) BMI 18.5 kg/m2 to 23 kg/m2 and waist circumference of \< 90 cm for men and \< 80 cm for women; (2) BMI 23.1 kg/m2 to 40 kg/m2 and waist circumference of ≥ 90 cm for men and ≥ 80 cm for women.
* Normally consumes three meals a day
* Able to walk continuously for 1 hour on a treadmill
* Weight stable for 3 months (\< 3kg change in weight)
* Regular menstrual cycle for the last 6 months (people taking the combined contraceptive pill are eligible for the study)
* Able to undergo a 45-minute MRI scan
Exclusion Criteria:
* Smokers (vaping is considered smoking in this study)
* Known medical conditions (e.g. diabetes, heart condition)
* Taking any medication which may affect the study outcomes (e.g. liraglutide, semaglutide, insulin, steroids, anti-psychotics)
* Clinically diagnosed eating disorder
* Previous bariatric surgery (e.g. gastric bypass, gastric band, sleeve gastrectomy)
* Food allergies or intolerances, or severe dislikes to study foods
* Pregnant or breastfeeding
* Have recently donated blood (within eight weeks of visits 2 and 3).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06849050
Study Brief:
Protocol Section:
NCT06849050