Health TrialsbyHealthPanel

Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

ConditionsSleep Onset LatencySleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-65
SponsorInstitute of Nutrition, Slovenia (Nutris)

About this trial

single-center, randomized, cross over, double-blind, placebo controlled intervention study

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Placebo product (PP)Placebo comparator 1 intervention
Group B: Active control (AC)Active comparator 1 intervention
Group C: Test product (TP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in sleep onset latency (SOL) compared to placebo

Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.

Time frame
last 7 days of intervention

Secondary outcomes

1

Changed sleep quality compared to placebo

Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)

Time frame
14 days
2

Changed sleep efficiency (SE) compared to placebo

Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy

Time frame
last 7 days of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Nutrition, Slovenia (Nutris)

Lead sponsor

Faculty of Pharmacy, University of Ljubljana, Slovenia

Collaborator

Faculty of health sciences, Celje, Slovenia

Collaborator

CMS - Center za motnje spanja, Ljubljana, Slovenia

Collaborator

Valens Int. d.o.o., Slovenija

Collaborator

Source ClinicalTrials.gov
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