Recruiting NCT06600633
Efficacy of Dietary Supplementation With Melatonin in Targeting 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: 14 days of intervention with Placebo Product (PP), 14 days of intervention with Active Control (AC), 14 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 →
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Official title
Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
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 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.
Interventions
- Dietary supplement 14 days of intervention with Placebo Product (PP)
1 spray (0 mg melatonin) - Dietary supplement 14 days of intervention with Active Control (AC)
1 spray (1 mg melatonin) - Dietary supplement 14 days of intervention with Test Product (TP)
1 spray (0.3 mg melatonin)
Primary outcome measures
- Change in sleep onset latency (SOL) compared to placebo [Time frame: last 7 days of intervention]
Secondary outcome measures (2)
- Changed sleep quality compared to placebo [Time frame: 14 days]
- Changed sleep efficiency (SE) compared to placebo [Time frame: last 7 days of intervention]
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 higher than 5
- no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9
- a body mass index (BMI) up to 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 clinically relevant symptoms/therapy)
- 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 (including as part of shift 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: NCT06600633 · KEP-4-6/2024-A · L7-50044