An interventional study of 14 days of intervention with Placebo Product (PP) and 14 days of intervention with Active Control (AC) in Sleep Onset Latency and Sleep Quality, sponsored by Institute of Nutrition, Slovenia (Nutris). Completed at 1 site in Slovenia. Open to participants aged 24 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Institute of Nutrition, Slovenia (Nutris) · Not applicable, Interventional, and Treatment
single-center, randomized, cross over, double-blind, placebo controlled intervention study
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 melatonin on sleep quality parameters.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's enrollment of 32 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Institute of Nutrition, Slovenia (Nutris) is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
Dietary Supplement: 14 days of intervention with Placebo Product (PP)
Active ingredient: 1 mg of melatonin per dosage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
Dietary Supplement: 14 days of intervention with Active Control (AC)
Active ingredient: 0.3 mg of melatonin per dossage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
Dietary Supplement: 14 days of intervention with Test Product (TP)
1 spray (0 mg melatonin)
1 spray (1 mg melatonin)
1 spray (0.3 mg melatonin)
Difference in sleep onset latency (SOL) compared to placebo
Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Time frame: intervention time of 2 weeks
Difference in sleep quality compared to placebo
Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 \[best\] to 21 \[worst\])
Time frame: intervention time of 2 weeks
Difference in sleep efficiency (SE) compared to placebo
Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy
Time frame: intervention time of 2 weeks
Plan to share: Undecided
Ran from Sep 2024 to primary completion in Feb 2025, 5 months.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 5 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: primary completion Sep 2025 → Feb 2025 and completion Sep 2025 → Feb 2025.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
Institute of Nutrition, Slovenia (Nutris)