Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06600633

Acronym

NutriSom-01A

Enrollment

Registered

2024-09-19

Start date

2024-09-17

Completion date

2025-09-17

Last updated

2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Onset Latency, Sleep Quality

Keywords

melatonin, supplementation, sleep, sleep onset latency, actigraphy, sleep quality, sleep efficiency

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 melatonin on sleep quality parameters.

Interventions

DIETARY_SUPPLEMENT14 days of intervention with Placebo Product (PP)

1 spray (0 mg melatonin)

DIETARY_SUPPLEMENT14 days of intervention with Active Control (AC)

1 spray (1 mg melatonin)

DIETARY_SUPPLEMENT14 days of intervention with Test Product (TP)

1 spray (0.3 mg melatonin)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Three-period crossover study will include 30 subjects who will test three formulations with diferent 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.

Eligibility

Sex/Gender

ALL

Age

24 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in sleep onset latency (SOL) compared to placebo	last 7 days of intervention	Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.

Secondary

Measure	Time frame	Description
Changed sleep quality compared to placebo	14 days	Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)
Changed sleep efficiency (SE) compared to placebo	last 7 days of intervention	Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy

Countries

Slovenia

Contacts

Primary ContactIgor Pravst, PhD

igor.pravst@nutris.org+386 590 68871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026