Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)
Trial statusNot yet recruiting
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
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 > 5
no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI <= 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
Treatments tested in this trial
- 21 days of intervention with Placebo Product (PP)
- 21 days of intervention with Active Control (AC)
- 21 days of intervention with Test Product (TP)
Treatment groups
70 Participants
are divided into 3 treatment groupsSponsors and collaborators
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