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

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07200167

Acronym

NutriSom-01B

Enrollment

Registered

2025-09-30

Start date

2025-10-01

Completion date

2026-10-30

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Onset Latency, Sleep Quality

Keywords

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

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENT21 days of intervention with Placebo Product (PP)

1 capsule (placebo)

DIETARY_SUPPLEMENT21 days of intervention with Active Control (AC)

1 capsule (melatonin)

DIETARY_SUPPLEMENT21 days of intervention with Test Product (TP)

1 capsule (valerian root extract)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

24 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Difference in sleep efficiency (SE) compared to placebo	2 weeks	Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy

Other

Measure	Time frame	Description
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

Countries

Slovenia

Contacts

Primary ContactIgor Pravst, PhD

igor.pravst@nutris.org+386 590 68871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026