[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648682":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":35,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":20,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"Sirio Pharma Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sleep Improvement Functional Food Intervention","EXPERIMENTAL","28-day daily consumption of test functional food, baseline and end-of-study assessments, daily sleep diaries, single-arm self-controlled design",[13],"Other: Sleep-improving Functional Food",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Sleep-improving Functional Food","28 days of daily consumption of test functional food; sleep assessment via baseline check-up and daily sleep diaries, single-arm self-controlled study.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yingzhi N\u002FA Chen","CONTACT","+86 18602053004","gz-chenyingzhi@kingmed.com.cn",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100648682","ganmaidazao-concentrated-beverage-sleep-assisting-trial-100648682",false,"NCT07726719","Ganmaidazao Concentrated Beverage Sleep-Assisting Trial","Inclusion Criteria:\n\n* Aged 18 to 60 years of any gender, with a history of staying up late or mild sleep disorder, and Pittsburgh Sleep Quality Index (PSQI) score between 7 and 15 points (mild to moderate sleep impairment).\n* Regular daily schedule with bedtime from 22:00 to 24:30 and wake-up time from 6:30 to 8:30; long-term daily schedule fluctuation ≤ 2 hours, and able to maintain a fixed schedule throughout the trial.\n* No abnormal saliva secretion and capable of completing saliva sample collection independently and normally.\n* Body Mass Index (BMI) ranging from 18.5 to 28.0, without extreme emaciation or obesity.\n* Able to participate in pre-trial centralized training and operational assessments (including wearable bracelet wearing, saliva collection, and questionnaire filling), and pass the assessment before enrollment.\n* No intake of sleep aids, anti-anxiety drugs, antidepressants, central nervous system regulators, sleep-improving health foods and related products within 2 weeks prior to enrollment.\n* Free from severe organic diseases, including cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, psychiatric disorders, and nervous system diseases.\n* Free from severe sleep disorder subtypes, such as obstructive sleep apnea syndrome.\n* No history of allergy to the ingredients and excipients of the test product, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Aged under 18 years or over 60 years.\n* Current smokers, or subjects with alcohol drinking habits of ≥3 times per week who have not quit alcohol within one month before the trial.\n* Long-term intake of stimulating beverages, defined as drinking strong tea, coffee or energy drinks ≥3 cups per day.\n* Experienced drastic changes in diet or daily routine within one month before enrollment, such as frequent business trips, travel, shift work, or dramatic dietary habit changes.\n* Diagnosed with severe sleep disorders or obstructive sleep apnea syndrome.\n* Participated in other human clinical trials, received professional sleep intervention therapy, or consumed products containing N-acetylneuraminic acid within one month before enrollment.\n* Pregnant or lactating females, or those planning to become pregnant within one year.\n* Long-term shift workers, regular severe night owls, or subjects with extremely unstable sleeping environments.\n* Intolerant to wearing smart wearable bracelets or unable to cooperate with trial-related examinations and sample collection.\n* Staff of the trial institution and other personnel involved in this project.\n* Scheduled to receive surgical treatment during the trial period.\n* With a history of severe food or drug allergies.\n* Diagnosed with digestive system organic lesions such as gastrointestinal ulcers and bleeding.\n* Suffering from severe physical and mental illnesses under treatment, severe cardiovascular, cerebrovascular and hematological diseases, severe liver and kidney dysfunction, pulmonary infection or malignant tumors.",true,"ALL","18 Years","60 Years",{"count":40,"type":41},25,"ESTIMATED","INTERVENTIONAL",[44],"NA","A human trial with blind method and self-control design was carried out to evaluate the sleep-improving function of a food. Indicators were detected by professional instruments and self-assessed by subjects. Relevant data before and after 28 consecutive days of test sample administration were collected for comparative analysis.",[47],"Sleep","NOT_YET_RECRUITING","2026-07-21",{"date":51,"type":52},"2026-07-24","ACTUAL",{"date":54,"type":41},"2026-08-01",{"date":56,"type":41},"2026-10-30",{"name":5,"class":6}]