Clinical trial NCT06600633: Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
Official title: Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Onset Latency
Sleep Quality
Keywords: melatonin
supplementation
sleep
sleep onset latency
actigraphy
sleep quality
sleep efficiency
Lead sponsor: Nutrition Institute, Slovenia
Sponsor class: OTHER
Collaborators: name: Faculty of Pharmacy, University of Ljubljana, Slovenia
name: Faculty of health sciences, Celje, Slovenia
name: CMS - Center za motnje spanja, Ljubljana, Slovenia
name: Valens Int. d.o.o., Slovenija
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three-period crossover study will include 30 subjects who will test three formulations with diferent melatonin dosages (placebo product without melatonin, and two products with different melatonin levels). Subjects will have 2 week intervention with each of the tested formulations with 2 week wash-out.
Primary purpose: TREATMENT

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 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.

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

Primary outcomes:
measure: Change in sleep onset latency (SOL) compared to placebo
timeFrame: last 7 days of intervention
Secondary outcomes:
measure: Changed sleep quality compared to placebo
timeFrame: 14 days
measure: Changed sleep efficiency (SE) compared to placebo
timeFrame: last 7 days of intervention
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: CMS - Center za motnje spanja
Study officials:
affiliation: Nutrition Institute, Ljubljana
name: Igor Pravst
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences in Celje, CMS - Center za motnje spanja
name: Barbara Gnidovec Stražišar
role: PRINCIPAL_INVESTIGATOR
References: