[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634246":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":46,"centralContacts":51,"locations":55,"responsibleParty":61,"collaborators":55,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":55,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":55,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":87,"whyStopped":55,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":55},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Inulin plus Spirulina","EXPERIMENTAL","Participants receive 15 g inulin plus 5 g spirulina dissolved in warm water, taken orally once daily after breakfast for 12 weeks.",[13,14],"Dietary Supplement: Inulin","Dietary Supplement: Spirulina",{"label":16,"type":10,"description":17,"interventionNames":18},"Inulin","Participants receive 15 g inulin plus 5 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks.",[13,19],"Dietary Supplement: Maltodextrin",{"label":21,"type":10,"description":22,"interventionNames":23},"Spirulina","Participants receive 5 g spirulina plus 15 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks.",[14,19],{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo","PLACEBO_COMPARATOR","Participants receive 20 g maltodextrin dissolved in warm water, taken orally once daily after breakfast for 12 weeks.",[19],[30,36,41],{"type":31,"name":16,"description":32,"armGroupLabels":33,"otherNames":34},"DIETARY_SUPPLEMENT","Inulin is a prebiotic dietary fiber used in this study to modulate gut microbiota and metabolic activity.",[16,9],[35],"Fructooligosaccharide",{"type":31,"name":21,"description":37,"armGroupLabels":38,"otherNames":39},"Spirulina is a nutrient-rich microalga with antioxidant and anti-inflammatory properties, used in this study as a dietary supplement.",[9,21],[40],"Arthrospira platensis",{"type":31,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Maltodextrin","Maltodextrin is used as a placebo control in this study and is matched in appearance and administration to the active interventions.",[16,25,21],[25],[47],{"name":48,"affiliation":49,"role":50},"Jing Lu, PhD","Zhejiang University","PRINCIPAL_INVESTIGATOR",[52,57],{"name":48,"role":53,"phone":54,"phoneExt":55,"email":56},"CONTACT","15858200010",null,"Lujing2016@zju.edu.cn",{"name":58,"role":53,"phone":59,"phoneExt":55,"email":60},"Wenhao Chen, MD","19857175751","chenwenhao@zju.edu.cn",{"type":50,"investigatorFullName":48,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Professor","100634246","inulin-spirulina-co-intervention-for-insomnia-disorder-100634246",false,"NCT07537192","Inulin-Spirulina Co-intervention for Insomnia Disorder","Investigation of the Therapeutic Efficacy and Mechanistic Pathways of Inulin-Spirulina Co-intervention in Patients With Insomnia Disorder: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 60 years;\n2. Meet the ICSD-3 diagnostic criteria for chronic insomnia disorder;\n3. Pittsburgh Sleep Quality Index (PSQI) total score \\> 5;\n4. Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of prebiotics, probiotics, high-fiber supplements, or microbiota-related products within the past 8 weeks;\n2. Diagnosis of psychiatric disorders other than insomnia based on DSM-5 criteria, assessed using the Mini-International Neuropsychiatric Interview (MINI);\n3. Regular use of sedative or hypnotic medications within the past 4 weeks, or frequent intermittent use (e.g., benzodiazepines, non-benzodiazepine receptor agonists, melatonin receptor agonists, sedating antihistamines);\n4. Severe hepatic or renal dysfunction, hematologic disorders, or respiratory diseases;\n5. Severe gastrointestinal diseases or malnutrition;\n6. Pregnancy or breastfeeding;\n7. Apnea-hypopnea index \\> 10, or periodic limb movement index \\> 15\u002Fhour on polysomnography;\n8. Known allergy or intolerance to inulin, spirulina, or maltodextrin;\n9. Participation in another clinical trial within the past 3 months.","ALL","18 Years","60 Years",{"count":74,"type":75},180,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to learn if inulin and spirulina, used alone or in combination, can improve insomnia disorder in adults aged 18 to 60 years with chronic insomnia disorder. It will also learn about the safety of these interventions. The main questions it aims to answer are:\n\nDoes inulin plus spirulina improve sleep quality, as measured by the reduction rate in Pittsburgh Sleep Quality Index (PSQI) score? Does the intervention improve sleep-related, mood, anxiety, and cognitive outcomes after 12 weeks? Researchers will compare an inulin group, a spirulina group, a combined inulin plus spirulina group, and a placebo group to see if the combined intervention provides greater benefit than either single intervention or placebo.\n\nParticipants will:\n\nbe randomly assigned to 1 of 4 groups: inulin, spirulina, inulin plus spirulina, or placebo; take the assigned study product once daily for 12 weeks; complete sleep, mood, anxiety, and cognitive assessments at baseline and week 12; undergo polysomnography and provide blood and stool samples at baseline and week 12; and be monitored for adverse events throughout the study.",[81,82],"Insomnia Disorder","Sleep Initiation and Maintenance Disorders",[16,21,84,85,86],"Gut Microbiota","Gut-Brain Axis","Insomnia","NOT_YET_RECRUITING","2026-05-15",{"date":90,"type":91},"2026-05-19","ACTUAL",{"date":93,"type":75},"2026-05-01",{"date":95,"type":75},"2027-04-30",{"name":5,"class":6}]