NCT06600633 Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
| NCT ID | NCT06600633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Nutrition, Slovenia (Nutris) |
| Condition | Sleep Onset Latency |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2025-09-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-09-17 with a primary completion date of 2025-09-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
single-center, randomized, cross over, double-blind, placebo controlled intervention study
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 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
Contact & Investigator
Igor Pravst
STUDY CHAIR
Nutrition Institute, Ljubljana
Frequently Asked Questions
Who can join the NCT06600633 clinical trial?
This trial is open to participants of all sexes, aged 24 Years or older, up to 65 Years, studying Sleep Onset Latency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06600633 currently recruiting?
Yes, NCT06600633 is actively recruiting participants. Contact the research team at igor.pravst@nutris.org for enrollment information.
Where is the NCT06600633 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT06600633 clinical trial?
NCT06600633 is sponsored by Institute of Nutrition, Slovenia (Nutris). The principal investigator is Igor Pravst at Nutrition Institute, Ljubljana. The trial plans to enroll 30 participants.