Efficacy of Dietary Supplementation With Melatonin in Tar... | NCT06600633

ID	Type	Description	Link
L7-50044	Other Grant/Funding Number	Slovenian Research and Innovation Agency

Status Module

Name	Class
Faculty of Pharmacy, University of Ljubljana, Slovenia	UNKNOWN
Faculty of health sciences, Celje, Slovenia	UNKNOWN
CMS - Center za motnje spanja, Ljubljana, Slovenia	UNKNOWN

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: 14 days of intervention with Placebo Product (PP)
Active control (AC)	Active Comparator	Active ingredient: 1 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: 14 days of intervention with Active Control (AC)
Test product (TP)	Experimental	Active ingredient: 0.3 mg of melatonin per dossage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.	Dietary Supplement: 14 days of intervention with Test Product (TP)

Name	Type	Description	Arm Group Labels	Other Names
14 days of intervention with Placebo Product (PP)	Dietary Supplement	1 spray (0 mg melatonin)	Placebo product (PP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in sleep onset latency (SOL) compared to placebo	Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.	last 7 days of intervention

Secondary Outcomes

Measure	Description	Time Frame
Changed sleep quality compared to placebo	Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)	14 days
Changed sleep efficiency (SE) compared to placebo

Eligibility Module

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

Name	Affiliation	Role
Igor Pravst	Nutrition Institute, Ljubljana	Study Chair
Barbara Gnidovec Stražišar	Faculty of Health Sciences in Celje, CMS - Center za motnje spanja	Principal Investigator