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

NCT07200167 | Not Yet Recruiting

• 3 other identifiers: KEP-4-6/2024-BL7-50044EFSA-2025-00036635
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Onset Latency; Sleep Quality

Keywords

melatonin; supplementation; sleep; sleep onset latency; actigraphy; sleep quality; sleep efficiency; valerian

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Difference in sleep efficiency (SE) compared to placebo

  2 weeks

Other Outcomes (2)

• Difference in sleep onset latency (SOL) compared to placebo

  3 weeks

• Difference in sleep efficiency (SE) compared to placebo

  3 weeks

Study Arms (3)

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.

Dietary Supplement: 21 days of intervention with Placebo Product (PP)

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.

Dietary Supplement: 21 days of intervention with Active Control (AC)

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.

Dietary Supplement: 21 days of intervention with Test Product (TP)

Interventions

21 days of intervention with Placebo Product (PP) DIETARY_SUPPLEMENT

1 capsule (placebo)

Placebo product (PP)

21 days of intervention with Active Control (AC) DIETARY_SUPPLEMENT

1 capsule (melatonin)

Active control (AC)

21 days of intervention with Test Product (TP) DIETARY_SUPPLEMENT

1 capsule (valerian root extract)

Test product (TP)

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• 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

Study Sites (1)

CMS - Center za motnje spanja

Ljubljana, 1000, Slovenia

Location

Related Links

• NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044)

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

Central Study Contacts

Igor Pravst, PhD

CONTACT

+386 590 68871; igor.pravst@nutris.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Igor Pravst

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

SL (1)