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| ID | Type | Description | Link |
|---|---|---|---|
| L7-50044 | Other Grant/Funding Number | Slovenian Research and Innovation Agency | |
| EFSA-2025-00036635 | Registry Identifier | EFSA Study Identification |
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| Name | Class |
|---|---|
| Faculty of Pharmacy, University of Ljubljana, Slovenia | UNKNOWN |
| Faculty of health sciences, Celje, Slovenia | UNKNOWN |
| CMS - Center za motnje spanja, Ljubljana, Slovenia | UNKNOWN |
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single-center, randomized, cross over, double-blind, placebo controlled intervention study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo product (PP) | Placebo Comparator | 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 | 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. |
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| Test product (TP) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 21 days of intervention with Placebo Product (PP) | Dietary Supplement | 1 capsule (placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in sleep onset latency (SOL) compared to placebo | Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy. | 2 weeks |
| Difference in sleep quality compared to placebo | Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 [best] to 21 [worst]) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in sleep efficiency (SE) compared to placebo | Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in sleep onset latency (SOL) compared to placebo | Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy. | 3 weeks |
| Difference in sleep efficiency (SE) compared to placebo |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Pravst, PhD | Contact | +386 590 68871 | igor.pravst@nutris.org |
| Name | Affiliation | Role |
|---|---|---|
| Igor Pravst | Institute of Nutrition, Slovenia (Nutris) | Study Chair |
| Barbara Gnidovec Stražišar | Faculty of Health Sciences in Celje, CMS - Center za motnje spanja | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMS - Center za motnje spanja | Ljubljana | 1000 | Slovenia |
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| Label | URL |
|---|---|
| NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044) | View source |
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| Valens Int. d.o.o., Slovenija |
| INDUSTRY |
Three-period crossover study will include 70 subjects who will test three formulations (placebo product without active ingredient, active control with melatonin, and test product with valerian root extract). Subjects will have 3 week intervention with each of the tested formulations with 2 week wash-out.
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| 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) |
|
Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy
| 3 weeks |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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