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:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT07200167
Eligibility Criteria:
Inclusion criteria:
* subject Informed consent form (ICF) is signed
* aged 24-65 years at the time of the signature of ICF
* suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI \> 5
* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI \<= 9
* a body mass index (BMI) \<= 32 kg/m2
* stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit
* ability to ingest oral food supplement (study product)
* willing to follow all study procedures, including attending all site visits and use of actigraphy
Exclusion criteria:
* diagnosed or subject to therapy due to sleep disorders
* acute infectious disease
* any kind of chronic pharmacological therapy with antihypertensives or antidepressants
* any kind of other pharmacological therapy that could interact with active ingredients used in the study
* pregnancy or planned pregnancy, lactation, menopause (with pharmacological treatment)
* use of beta-blockers
* chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen
* supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks
* unwillingness to maintain caffeine abstinence after 4:00 PM during the study
* not having a mobile upper extremity for attaching an actigraph
* known alcohol and/or drug abuse
* unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study
* known lactose/gluten intolerances/food allergies
* known gastrointestinal disease
* less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
* have stomach or bowel resection
* night work or work shifts with night work
* mental incapacity that precludes adequate understanding or cooperation
* participation in another investigational study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Years
Maximum Age:
65 Years
Study:
NCT07200167
Study Brief:
Protocol Section:
NCT07200167