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Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)

NCT07200167 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-10-06

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

21 days of intervention with Placebo Product (PP)

1 capsule (placebo)

DIETARY_SUPPLEMENT

21 days of intervention with Active Control (AC)

1 capsule (melatonin)

DIETARY_SUPPLEMENT

21 days of intervention with Test Product (TP)

1 capsule (valerian root extract)

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 · Institute of Nutrition, Slovenia (Nutris)

  • 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
2025-10-01
Primary Completion
2026-07-01
Completion
2026-10-30

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 NCT07200167 on ClinicalTrials.gov