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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT05977569
Eligibility Criteria:
Inclusion Criteria:
* • Body mass index 20.0-29.9 kg∙m-2
* Age 18-45 years
* Willing to abstain from food intake for just over 3 days (\~82 hours)
* Able and willing to provide informed consent and safely comply with study procedures
* Females to maintain record of regular menstrual cycle phase or contraceptive use
* No anticipated changes in lifestyle during the study (e.g. holidays or exercise programmes)
Exclusion Criteria:
* • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
* Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
* Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
* Pregnancy
* Breastfeeding
* Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
* History of eating disorders (e.g. anorexia)
* Any reported recent (\<6 months) change in body mass (± 3%)
* Uncontrolled hyperthyroidism
* Advanced cerebrovascular insufficiency or dementia
* Advanced liver or kidney insufficiency
* History of migraine and or headache
* Psychotic disorders
* Unstable or severe coronary artery disease
* Retinal detachment
* Duodenal or stomach ulcer
* Cancer and malignant disease
* Regular use of Non-steroidal anti-inflammatory drugs (NSAIDs)
* Use of Systemic corticoids
* Use of Antihypertensives (especially beta-blockers and diuretics)
* Use of Antidiabetics
* Use of Anti-coagulants
* Use of Psychotropics (especially neuroleptics and lithium)
* Use of Anticonvulsants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05977569
Study Brief:
Protocol Section:
NCT05977569