Testing melatonin supplements for better sleep quality
Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
NA · Institute of Nutrition, Slovenia (Nutris) · NCT06600633
This study is testing if melatonin supplements can help adults aged 24-65 sleep better by comparing different doses to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 24 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Nutrition, Slovenia (Nutris) (other) |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06600633 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of different dosages of melatonin supplements on sleep quality in adults aged 24-65. It is a single-center, randomized, crossover, double-blind, placebo-controlled intervention involving 30 participants. Each participant will undergo three 14-day intervention periods with either a placebo, an active control, or a test product containing melatonin, while their sleep quality will be monitored using actigraphy. The goal is to determine how well melatonin supplementation can improve sleep onset latency and overall sleep quality.
Who should consider this trial
Good fit: Ideal candidates are adults aged 24-65 with suboptimal sleep quality but no diagnosed sleep disorders.
Not a fit: Patients with diagnosed sleep disorders or those on chronic medications that may interact with the study products are unlikely to benefit.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective dietary supplement option for individuals struggling with sleep quality.
How similar studies have performed: Previous studies have shown promising results with melatonin supplementation for improving sleep quality, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- CMS - Center za motnje spanja — Ljubljana, Slovenia (RECRUITING)
Study contacts
- Principal investigator: Barbara Gnidovec Stražišar — Faculty of Health Sciences in Celje, CMS - Center za motnje spanja
- Study coordinator: Igor Pravst, PhD
- Email: igor.pravst@nutris.org
- Phone: +386 590 68871
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Onset Latency, Sleep Quality, melatonin, supplementation, sleep, sleep onset latency, actigraphy, sleep quality