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

NCT07200167 — Not applicable, Completed, 70 participants, Institute of Nutrition, Slovenia (Nutris)

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

Registry	NCT07200167, acronym NutriSom-01B
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	70 (Actual)
Sponsor	Institute of Nutrition, Slovenia (Nutris) (Other); collaborators: Faculty of Pharmacy, University of Ljubljana, Slovenia, Faculty of health sciences, Celje, Slovenia, CMS - Center za motnje spanja, Ljubljana, Slovenia, Valens Int. d.o.o., Slovenija
Conditions	Sleep Onset Latency, Sleep Quality
Interventions	21 days of intervention with Placebo Product (PP), 21 days of intervention with Active Control (AC), 21 days of intervention with Test Product (TP) (Dietary supplement)
Dates	start 2025-09-29, primary completion 2026-07-01, completion 2026-07-13, first posted 2025-09-30, last updated 2026-10-19
Locations	1 site in Slovenia

-Summary

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

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+Detailed description

The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 70 subjects who will test the efficacy of three formulations on sleep quality parameters.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo product (PP)	Placebo comparator	Dietary Supplement: 21 days of intervention with Placebo Product (PP)	Active ingredient: none. Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
Active control (AC)	Active comparator	Dietary Supplement: 21 days of intervention with Active Control (AC)	Active ingredient: 0.3 mg of melatonin per dosage. Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.
Test product (TP)	Experimental	Dietary Supplement: 21 days of intervention with Test Product (TP)	Active ingredient: 480 mg of standardised dry hydroalcoholic extract Valeriana officinalis L., radix (Valerian root) \[Ph. Eur. 1898\] Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.

21 days of intervention with Placebo Product (PP) (Dietary supplement): 1 capsule (placebo)
21 days of intervention with Active Control (AC) (Dietary supplement): 1 capsule (melatonin)
21 days of intervention with Test Product (TP) (Dietary supplement): 1 capsule (valerian root extract)

+Outcome measures

Primary outcomes

Difference in sleep onset latency (SOL) compared to placebo [2 weeks]: Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Difference in sleep quality compared to placebo [2 weeks]: Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 \[best\] to 21 \[worst\])

Secondary outcomes

Difference in sleep efficiency (SE) compared to placebo [2 weeks]: Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy

Other outcomes

Difference in sleep onset latency (SOL) compared to placebo [3 weeks]: Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.
Difference in sleep efficiency (SE) compared to placebo [3 weeks]: Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy

+Eligibility

Sex: All, ages: 24 Years to 65 Years, accepts healthy volunteers

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 > 5
* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI <= 9
* a body mass index (BMI) <= 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 pharmacological treatment)
* 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 or work shifts with night work
* mental incapacity that precludes adequate understanding or cooperation
* participation in another investigational study

+Locations (1)

Facility	City	Country	Status
CMS - Center za motnje spanja	Ljubljana	Slovenia

+Investigators

Igor Pravst, Study chair, Institute of Nutrition, Slovenia (Nutris)
Barbara Gnidovec Stražišar, Principal investigator, Faculty of Health Sciences in Celje, CMS - Center za motnje spanja