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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT06239168
Eligibility Criteria:
Inclusion Criteria:
* Healthy individuals with (minor) sleep disturbance
* Age 40-70 years
* BMI 18.5 - 30 kg/m2
* Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Exclusion Criteria:
* Excessive caffeine use
* Major psychiatric/mental health disorders .
* Chronic sleep disorders
* Severe sleep disturbance for more than 1 year
* Other clear causes for poor sleep quality or mental wellbeing
* Use of medication or supplements that can affect outcomes
* Nonpharmacological treatment for sleep disorders
* Flight from a time-zone with \>3 h difference ≤1 week before an intervention period
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study
* Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
* Reported weight loss or weight gain of \>3 kg in the month prior to pre-study screening
* Smoking
* Abuse of products
* Known allergy to citruses
* Known pregnancy or lactation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06239168
Study Brief:
Protocol Section:
NCT06239168