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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05866406
Eligibility Criteria:
Inclusion Criteria:
* must be able to grant voluntary informed consent and comply with the study instructions
* aged 25-75 years
* men and women
* body mass index 27-45 kg/m2
* fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
* self-reported habitual eating period ≥ 13 h per day
Exclusion Criteria:
* shift worker
* fasting \>12 h/day more than once a week
* vegan
* \> once a week no food intake after \~1800 h
* habitually waking up before \~0400 h and sleeping before \~2100 h
* unstable weight (\>5% change the last 2 months)
* Clinical diagnosis of type 1 or 2 diabetes
* Clinical diagnosis of sleep disorder
* Clinical diagnosis of eating disorder
* Clinical diagnosis of cancer in last 5 years
* conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.)
* smoking and illegal drug use
* pregnant or lactating
* gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
* individuals with electromedical devises
* prisoners
* alcohol abuse
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT05866406
Study Brief:
Protocol Section:
NCT05866406