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Not yet recruiting NCT07200167

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

No phase Interventional Sleep Onset Latency Sleep Quality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 21 days of intervention with Placebo Product (PP), 21 days of intervention with Active Control (AC), 21 days of intervention with Test Product (TP).
Who it may be relevant to
Registry conditions: Sleep Onset Latency, Sleep Quality. Basic parameters: 24 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Difference in sleep onset latency (SOL) compared to placebo [Time frame: 2 weeks]
  • Difference in sleep quality compared to placebo [Time frame: 2 weeks]
Secondary outcome measures (1)
  • Difference in sleep efficiency (SE) compared to placebo [Time frame: 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Slovenia · 1 center
  • CMS - Center za motnje spanja — Ljubljana

Identifiers

NCT: NCT07200167 · KEP-4-6/2024-B · L7-50044 · EFSA-2025-00036635

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗