Status:
RECRUITING
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
Lead Sponsor:
Institute of Nutrition, Slovenia (Nutris)
Collaborating Sponsors:
Faculty of Pharmacy, University of Ljubljana, Slovenia
Faculty of health sciences, Celje, Slovenia
Conditions:
Sleep Onset Latency
Sleep Quality
Eligibility:
All Genders
24-65 years
Phase:
NA
Brief Summary
single-center, randomized, cross over, double-blind, placebo controlled intervention study
Detailed Description
The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 30 subjects who will test the efficacy of three formulations with different dosages of melat...
Eligibility Criteria
Inclusion
- 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 higher than 5
- no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
- a body mass index (BMI) up to 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 clinically relevant symptoms/therapy)
- 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 (including as part of shift work)
- mental incapacity that precludes adequate understanding or cooperation
- participation in another investigational study
Exclusion
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 17 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06600633
Start Date
September 17 2024
End Date
September 17 2025
Last Update
September 20 2024
Active Locations (1)
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1
CMS - Center za motnje spanja
Ljubljana, Slovenia, 1000