Sleep Onset LatencyNutriSom-01ANCT06600633
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
A study testing 14 days of intervention with Test Product (TP) in people with Sleep Onset Latency and Sleep Quality, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial summary
single-center, randomized, cross over, double-blind, placebo controlled intervention study Read more about this study
- Who is it for?
- Ages 24 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Onset Latency, Sleep Quality
- What is being tested?
- 14 days of intervention with Test Product (TP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 Sep 2024to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
single-center, randomized, cross over, double-blind, placebo controlled intervention study
Read the 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 melatonin on sleep quality parameters.
- Conditions
- Sleep Onset Latency, Sleep Quality
- Being tested
- 14 days of intervention with Placebo Product (PP), 14 days of intervention with Active Control (AC), 14 days of intervention with Test Product (TP)
- Keywords
- melatonin, supplementation, sleep, sleep onset latency, actigraphy, sleep quality, sleep efficiency
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14 days of intervention with Placebo Product (PP)Dietary supplement
1 spray (0 mg melatonin)
14 days of intervention with Active Control (AC)Dietary supplement
1 spray (1 mg melatonin)
14 days of intervention with Test Product (TP)Dietary supplement
1 spray (0.3 mg melatonin)
| Study group | Role | What they receive |
|---|---|---|
| Placebo product (PP) | Placebo comparator | Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime. Receives: Dietary Supplement: 14 days of intervention with Placebo Product (PP) |
| Active control (AC) | Active comparator | 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. Receives: Dietary Supplement: 14 days of intervention with Active Control (AC) |
| Test product (TP) | Experimental | 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. Receives: Dietary Supplement: 14 days of intervention with Test Product (TP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in sleep onset latency (SOL) compared to placebo
Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Measured: intervention time of 2 weeks
Secondary outcomes (2)
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])
Measured: intervention time of 2 weeks
Difference in sleep efficiency (SE) compared to placebo
Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy
Measured: intervention time of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion17 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Onset LatencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-period crossover study will include 30 subjects who will test three formulations with different melatonin dosages (placebo product without melatonin, and two products with different melatonin levels). Subjects will have 2 week intervention with each of the tested formulations with 2 week wash-out.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty of Pharmacy, University of Ljubljana, Slovenia, Faculty of health sciences, Celje, Slovenia, CMS - Center za motnje spanja, Ljubljana, Slovenia, Valens Int. d.o.o., Slovenija
- Responsible party
- Principal investigator, Igor Pravst, Institute of Nutrition, Slovenia (Nutris)
- Investigators
- Igor Pravst, Study chair, Institute of Nutrition, LjubljanaBarbara Gnidovec Stražišar, Principal investigator, Faculty of Health Sciences in Celje, CMS - Center za motnje spanja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600633
- Sponsor's protocol ID
- KEP-4-6/2024-A
- Other IDs
- L7-50044
- Acronym
- NutriSom-01A
- Status last verified
- Oct 2026
- First submitted
- 12 Sep 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
- ClinicalTrials.gov ID
- NCT06600633
- Acronym / sponsor ID
- NutriSom-01A / KEP-4-6/2024-A
- Conditions
- Sleep Onset Latency, Sleep Quality
- Keywords
- melatonin, supplementation, sleep, sleep onset latency, actigraphy, sleep quality, sleep efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- Faculty of Pharmacy, University of Ljubljana, Slovenia, Faculty of health sciences, Celje, Slovenia, CMS - Center za motnje spanja, Ljubljana, Slovenia, Valens Int. d.o.o., Slovenija
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 melatonin on sleep quality parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-period crossover study will include 30 subjects who will test three formulations with different melatonin dosages (placebo product without melatonin, and two products with different melatonin levels). Subjects will have 2 week intervention with each of the tested formulations with 2 week wash-out.
| Arm | Type | Receives |
|---|---|---|
| Placebo product (PP) | Placebo comparator | Dietary Supplement: 14 days of intervention with Placebo Product (PP)Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime. |
| Active control (AC) | Active comparator | Dietary Supplement: 14 days of intervention with Active Control (AC)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. |
| Test product (TP) | Experimental | Dietary Supplement: 14 days of intervention with Test Product (TP)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. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14 days of intervention with Placebo Product (PP)1 spray (0 mg melatonin) | Dietary supplement | Placebo product (PP) |
| 14 days of intervention with Active Control (AC)1 spray (1 mg melatonin) | Dietary supplement | Active control (AC) |
| 14 days of intervention with Test Product (TP)1 spray (0.3 mg melatonin) | Dietary supplement | Test product (TP) |
Primary outcome
Difference in sleep onset latency (SOL) compared to placebo
Time frame: intervention time of 2 weeks
Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
2 secondary outcomes
Difference in sleep quality compared to placebo
Time frame: intervention time of 2 weeks
Difference in sleep efficiency (SE) compared to placebo
Time frame: intervention time of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Pravst study chair
Institute of Nutrition, Ljubljana
Barbara Gnidovec Stražišar principal investigator
Faculty of Health Sciences in Celje, CMS - Center za motnje spanja
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14 days of intervention with Test Product (TP) in people with Sleep Onset Latency and Sleep Quality, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in sleep onset latency (SOL) compared to placebo (time frame: intervention time of 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.