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Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality

NCT06600633 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-20

No results posted yet for this study

Summary

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

Conditions

  • Sleep Onset Latency
  • Sleep Quality

Interventions

DIETARY_SUPPLEMENT

14 days of intervention with Placebo Product (PP)

1 spray (0 mg melatonin)

DIETARY_SUPPLEMENT

14 days of intervention with Active Control (AC)

1 spray (1 mg melatonin)

DIETARY_SUPPLEMENT

14 days of intervention with Test Product (TP)

1 spray (0.3 mg melatonin)

Sponsors & Collaborators

  • Faculty of Pharmacy, University of Ljubljana, Slovenia

    collaborator UNKNOWN

  • Faculty of health sciences, Celje, Slovenia

    collaborator UNKNOWN

  • CMS - Center za motnje spanja, Ljubljana, Slovenia

    collaborator UNKNOWN

  • Valens Int. d.o.o., Slovenija

    collaborator INDUSTRY

  • Institute of Nutrition, Slovenia (Nutris)

    lead OTHER

Principal Investigators

  • Igor Pravst · Nutrition Institute, Ljubljana

  • Barbara Gnidovec Stražišar · Faculty of Health Sciences in Celje, CMS - Center za motnje spanja

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-09-17
Completion
2025-09-17

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600633 on ClinicalTrials.gov