[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562243":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":34,"studyPopulation":21,"armGroups":35,"interventions":54,"overallOfficials":68,"centralContacts":77,"locations":83,"responsibleParty":102,"collaborators":104,"id":115,"slug":21,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":21,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":86,"whyStopped":21,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Institute of Nutrition, Slovenia (Nutris)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18],{"measure":15,"description":16,"timeFrame":17},"Changed sleep quality compared to placebo","Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)","14 days",{"measure":19,"description":20,"timeFrame":12},"Changed sleep efficiency (SE) compared to placebo","Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":25,"primaryPurpose":26,"observationalModel":21,"timePerspective":21,"maskingInfo":27},"RANDOMIZED","CROSSOVER","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.","TREATMENT",{"masking":28,"maskingDescription":21,"whoMasked":29},"QUADRUPLE",[30,31,32,33],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[36,42,48],{"label":37,"type":38,"description":39,"interventionNames":40},"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.",[41],"Dietary Supplement: 14 days of intervention with Placebo Product (PP)",{"label":43,"type":44,"description":45,"interventionNames":46},"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.",[47],"Dietary Supplement: 14 days of intervention with Active Control (AC)",{"label":49,"type":50,"description":51,"interventionNames":52},"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.",[53],"Dietary Supplement: 14 days of intervention with Test Product (TP)",[55,60,64],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":21},"DIETARY_SUPPLEMENT","14 days of intervention with Placebo Product (PP)","1 spray (0 mg melatonin)",[37],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":21},"14 days of intervention with Active Control (AC)","1 spray (1 mg melatonin)",[43],{"type":56,"name":65,"description":66,"armGroupLabels":67,"otherNames":21},"14 days of intervention with Test Product (TP)","1 spray (0.3 mg melatonin)",[49],[69,73],{"name":70,"affiliation":71,"role":72},"Igor Pravst","Nutrition Institute, Ljubljana","STUDY_CHAIR",{"name":74,"affiliation":75,"role":76},"Barbara Gnidovec Stražišar","Faculty of Health Sciences in Celje, CMS - Center za motnje spanja","PRINCIPAL_INVESTIGATOR",[78],{"name":79,"role":80,"phone":81,"phoneExt":21,"email":82},"Igor Pravst, PhD","CONTACT","+386 590 68871","igor.pravst@nutris.org",[84],{"facility":85,"status":86,"city":87,"state":21,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"CMS - Center za motnje spanja","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":92,"coordinates":93},"Point",[94,95],14.50513,46.05108,{"lat":95,"lon":94},[98,101],{"name":74,"role":80,"phone":99,"phoneExt":21,"email":100},"+386 590 68 70","raziskave@nutris.org",{"name":74,"role":76,"phone":21,"phoneExt":21,"email":21},{"type":76,"investigatorFullName":70,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"Prof. Dr. Igor Pravst",[105,108,110,112],{"name":106,"class":107},"Faculty of Pharmacy, University of Ljubljana, Slovenia","UNKNOWN",{"name":109,"class":107},"Faculty of health sciences, Celje, Slovenia",{"name":111,"class":107},"CMS - Center za motnje spanja, Ljubljana, Slovenia",{"name":113,"class":114},"Valens Int. d.o.o., Slovenija","INDUSTRY","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":127,"type":128},30,"ESTIMATED","INTERVENTIONAL",[131],"NA","single-center, randomized, cross over, double-blind, placebo controlled intervention study",[134,135],"Sleep Onset Latency","Sleep Quality",[137,138,139,140,141,142,143],"melatonin","supplementation","sleep","sleep onset latency","actigraphy","sleep quality","sleep efficiency","2024-09-18",{"date":146,"type":147},"2024-09-20","ACTUAL",{"date":149,"type":147},"2024-09-17",{"date":151,"type":128},"2025-09-17",{"name":5,"class":6},1]