[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645147":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":62,"collaborators":64,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":93,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Nutraland USA, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ZenRest™ Group","EXPERIMENTAL","50 mg proprietary lotus seed and rice germ extract blend capsule, taken once daily, 30-60 minutes before bedtime for 6 weeks (42 days).",[13],"Dietary Supplement: Lotus Seed & Rice Germ Extract",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","An identical look-alike microcrystalline cellulose capsule, taken once daily 30-60 minutes before bedtime for 6 weeks (42 days).",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Lotus Seed & Rice Germ Extract","A proprietary blend of Lotus Seed Extract (Nelumbo nucifera) standardized to contain Neferine \\>\u002F=2.0% and Isoquercitrin \\& Hyperoside \\>\u002F=0.5%, and Rice Germ Extract (Oryza sativa) providing Polyamines \\>\u002F=0.5% calculated as spermidine. Administered as a 50 mg capsule taken orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"OTHER","An identical, matching inactive look-alike capsule containing microcrystalline cellulose. Administered orally once daily, 30-60 minutes before bedtime, for 6 weeks (42 days).",[15],[32],{"name":33,"affiliation":34,"role":35},"Dr. Bill Clark, PhD","Natprologix, LLC","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Dr. Bill Clark, Ph.D.","CONTACT","727-365-3420","drbill@natprologix.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Alethios, Inc.","650-206-8006","support@alethios.com",[47],{"facility":43,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"San Francisco","California","94109","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.41942,37.77493,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":44,"phoneExt":26,"email":45},"Zeenia Framroze, BA MPhil",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65],{"name":43,"class":6},"100645147","effect-of-zenrest-lotus-seed--rice-germ-extract-blend-on-sleep-quality-in-menopausal-women-100645147",false,"NCT07678359","Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women","A Randomized, Double-Blind, Placebo-Controlled, 6-Week Pilot Study to Evaluate the Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women","Inclusion Criteria:\n\n* Female, aged 40-65 years at time of enrollment\n* Confirmed menopausal status: (a) natural menopause (≥12 consecutive months of amenorrhea without other clinical cause), or (b) surgical menopause (bilateral oophorectomy with documented date of procedure)\n* Positive onboarding sleep screener: rates sleep quality as \"Fairly Bad\" or \"Very Bad\" AND reports sleep difficulty at least once per week in the prior month\n* PSQI global score \\>5 at T0 baseline assessment (formal eligibility gate)\n* Owns and actively uses an Oura Ring Generation 4 at time of enrollment\n* Demonstrates ≥80% Oura Ring wear compliance in the 30 days prior to enrollment, confirmed via Alethios platform sync at onboarding\n* Willing to wear Oura Ring Generation 4 continuously for 42 nights throughout the study period\n* Willing to maintain stable diet, sleep habits, medications, and supplement use throughout the 42-day study period\n* No planned major disruptions to sleep schedule, shift work, or travel across ≥3 time zones during the study period\n* Access to a smartphone or computer to complete eConsent and digital questionnaires\n* Able to provide informed consent via the Alethios eConsent platform\n\nExclusion Criteria:\n\n* Current use of prescription sleep medications (benzodiazepines, non-benzodiazepine hypnotics, doxepin, suvorexant) within 30 days of enrollment\n* Current use of melatonin supplements at doses \\>1 mg\u002Fday within 14 days of enrollment\n* Diagnosis of a clinically significant sleep disorder requiring treatment (obstructive sleep apnea unless adequately treated and stable, restless legs syndrome, narcolepsy)\n* Diagnosis of a major psychiatric disorder currently requiring pharmacological treatment\n* Current use of hormone replacement therapy initiated within 90 days of enrollment, or any planned changes to HRT during the study (stable long-term HRT is acceptable)\n* Regular use of GABAergic, serotonergic, or sedating supplements (valerian, passionflower, ashwagandha, kava) within 14 days of enrollment\n* Shift work or schedule regularly requiring sleep between 06:00 and 22:00\n* Planned travel across 3 or more time zones during the 42-day study period\n* Known allergy to lotus, rice, or related botanicals\n* Active cardiovascular, hepatic, renal, or neurological condition that in the PI's judgment would affect sleep or participant safety\n* Participation in another interventional study within 30 days of enrollment\n* In the opinion of the PI, any condition compromising participant safety or data integrity",true,"FEMALE","40 Years","65 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed \\& Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints.\n\nThe main questions it aims to answer are:\n\n* Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo?\n* Does ZenRest™ improve objective sleep metrics, specifically sleep efficiency, when monitored via an Oura Ring wearable device?\n* Does the extract improve secondary sleep and lifestyle factors, such as insomnia severity, daytime sleepiness, and vitality? Researchers will compare ZenRest™ to a placebo (a look-alike capsule that contains no active ingredients) to see if the botanical blend has a measurable effect on sleep quality.",[85,86],"Sleep Quality","Menopause",[88,89,90,91,92,86,85],"ZenRest","Lotus Seed Extract","Rice Germ Extract","Spermidine","Neferine","NOT_YET_RECRUITING","2026-06-25",{"date":96,"type":97},"2026-07-01","ACTUAL",{"date":99,"type":79},"2026-07",{"date":101,"type":79},"2026-10",{"name":5,"class":6},1]