[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562243":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":77,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":32,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":59,"whyStopped":32,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Institute of Nutrition, Slovenia (Nutris)","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Dietary Supplement: 14 days of intervention with Placebo Product (PP)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Dietary Supplement: 14 days of intervention with Active Control (AC)",{"label":21,"type":22,"description":23,"interventionNames":24},"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.",[25],"Dietary Supplement: 14 days of intervention with Test Product (TP)",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","14 days of intervention with Placebo Product (PP)","1 spray (0 mg melatonin)",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"14 days of intervention with Active Control (AC)","1 spray (1 mg melatonin)",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"14 days of intervention with Test Product (TP)","1 spray (0.3 mg melatonin)",[21],[42,46],{"name":43,"affiliation":44,"role":45},"Igor Pravst","Nutrition Institute, Ljubljana","STUDY_CHAIR",{"name":47,"affiliation":48,"role":49},"Barbara Gnidovec Stražišar","Faculty of Health Sciences in Celje, CMS - Center za motnje spanja","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Igor Pravst, PhD","CONTACT","+386 590 68871","igor.pravst@nutris.org",[57],{"facility":58,"status":59,"city":60,"state":32,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"CMS - Center za motnje spanja","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":65,"coordinates":66},"Point",[67,68],14.50513,46.05108,{"lat":68,"lon":67},[71,74],{"name":47,"role":53,"phone":72,"phoneExt":32,"email":73},"+386 590 68 70","raziskave@nutris.org",{"name":47,"role":49,"phone":32,"phoneExt":32,"email":32},{"type":49,"investigatorFullName":43,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Prof. Dr. Igor Pravst",[78,81,83,85],{"name":79,"class":80},"Faculty of Pharmacy, University of Ljubljana, Slovenia","UNKNOWN",{"name":82,"class":80},"Faculty of health sciences, Celje, Slovenia",{"name":84,"class":80},"CMS - Center za motnje spanja, Ljubljana, Slovenia",{"name":86,"class":87},"Valens Int. d.o.o., Slovenija","INDUSTRY","100562243","efficacy-of-dietary-supplementation-with-melatonin-in-targeting-sleep-quality-100562243",false,"NCT06600633","Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality","Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)","NutriSom-01A","Inclusion criteria:\n\n* subject Informed consent form (ICF) is signed\n* aged 24-65 years at the time of the signature of ICF\n* suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5\n* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9\n* a body mass index (BMI) up to 32 kg\u002Fm2\n* stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit\n* ability to ingest oral food supplement (study product)\n* willing to follow all study procedures, including attending all site visits and use of actigraphy\n\nExclusion criteria:\n\n* diagnosed or subject to therapy due to sleep disorders\n* acute infectious disease\n* any kind of chronic pharmacological therapy with antihypertensives or antidepressants\n* any kind of other pharmacological therapy that could interact with active ingredients used in the study\n* pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms\u002Ftherapy)\n* use of beta-blockers\n* chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen\n* supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks\n* unwillingness to maintain caffeine abstinence after 4:00 PM during the study\n* not having a mobile upper extremity for attaching an actigraph\n* known alcohol and\u002For drug abuse\n* 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\n* known lactose\u002Fgluten intolerances\u002Ffood allergies\n* known gastrointestinal disease\n* less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)\n* have stomach or bowel resection\n* night work (including as part of shift work)\n* mental incapacity that precludes adequate understanding or cooperation\n* participation in another investigational study",true,"ALL","24 Years","65 Years",{"count":101,"type":102},30,"ESTIMATED","INTERVENTIONAL",[105],"NA","single-center, randomized, cross over, double-blind, placebo controlled intervention study",[108,109],"Sleep Onset Latency","Sleep Quality",[111,112,113,114,115,116,117],"melatonin","supplementation","sleep","sleep onset latency","actigraphy","sleep quality","sleep efficiency","2024-09-18",{"date":120,"type":121},"2024-09-20","ACTUAL",{"date":123,"type":121},"2024-09-17",{"date":125,"type":102},"2025-09-17",{"name":5,"class":6},1]