[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608331":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":41,"centralContacts":49,"locations":55,"responsibleParty":73,"collaborators":75,"id":86,"slug":32,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":32,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":116,"whyStopped":32,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"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: 21 days of intervention with Placebo Product (PP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active control (AC)","ACTIVE_COMPARATOR","Active ingredient: 0.3 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: 21 days of intervention with Active Control (AC)",{"label":21,"type":22,"description":23,"interventionNames":24},"Test product (TP)","EXPERIMENTAL","Active ingredient: 480 mg of standardised dry hydroalcoholic extract Valeriana officinalis L., radix (Valerian root) \\[Ph. Eur. 1898\\] Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.",[25],"Dietary Supplement: 21 days of intervention with Test Product (TP)",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","21 days of intervention with Placebo Product (PP)","1 capsule (placebo)",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"21 days of intervention with Active Control (AC)","1 capsule (melatonin)",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"21 days of intervention with Test Product (TP)","1 capsule (valerian root extract)",[21],[42,45],{"name":43,"affiliation":5,"role":44},"Igor Pravst","STUDY_CHAIR",{"name":46,"affiliation":47,"role":48},"Barbara Gnidovec Stražišar","Faculty of Health Sciences in Celje, CMS - Center za motnje spanja","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":32,"email":54},"Igor Pravst, PhD","CONTACT","+386 590 68871","igor.pravst@nutris.org",[56],{"facility":57,"status":32,"city":58,"state":32,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"CMS - Center za motnje spanja","Ljubljana","1000","Slovenia","SI",{"type":63,"coordinates":64},"Point",[65,66],14.50513,46.05108,{"lat":66,"lon":65},[69,72],{"name":46,"role":52,"phone":70,"phoneExt":32,"email":71},"+386 590 68 70","raziskave@nutris.org",{"name":46,"role":48,"phone":32,"phoneExt":32,"email":32},{"type":48,"investigatorFullName":43,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Prof. Dr. Igor Pravst",[76,79,81,83],{"name":77,"class":78},"Faculty of Pharmacy, University of Ljubljana, Slovenia","UNKNOWN",{"name":80,"class":78},"Faculty of health sciences, Celje, Slovenia",{"name":82,"class":78},"CMS - Center za motnje spanja, Ljubljana, Slovenia",{"name":84,"class":85},"Valens Int. d.o.o., Slovenija","INDUSTRY","100608331",false,"NCT07200167","Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)","Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study B)","NutriSom-01B","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 \\> 5\n* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI \\\u003C= 9\n* a body mass index (BMI) \\\u003C= 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 pharmacological treatment)\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 or work shifts with night work\n* mental incapacity that precludes adequate understanding or cooperation\n* participation in another investigational study",true,"ALL","24 Years","65 Years",{"count":98,"type":99},70,"ESTIMATED","INTERVENTIONAL",[102],"NA","single-center, randomized, cross over, double-blind, placebo controlled intervention study",[105,106],"Sleep Onset Latency","Sleep Quality",[108,109,110,111,112,113,114,115],"melatonin","supplementation","sleep","sleep onset latency","actigraphy","sleep quality","sleep efficiency","valerian","NOT_YET_RECRUITING","2025-09-30",{"date":119,"type":120},"2025-10-06","ACTUAL",{"date":122,"type":99},"2025-10-01",{"date":124,"type":99},"2026-10-30",{"name":5,"class":6},1]