[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659304":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":72,"studyPopulation":61,"armGroups":73,"interventions":86,"overallOfficials":61,"centralContacts":95,"locations":101,"responsibleParty":118,"collaborators":61,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":61,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":61,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":104,"whyStopped":61,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"University of Alicante","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":61},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Menopause Rating Scale (MRS) Total Score","Change in menopausal symptom severity assessed using the Menopause Rating Scale (MRS). The questionnaire includes 11 items scored from 0 to 4, with a total score ranging from 0 to 44. Higher scores indicate more severe symptoms.","Baseline and Week 12",{"measure":14,"description":15,"timeFrame":16},"Change From Baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) Domain Scores","Change in menopause-related quality of life assessed using the MENQOL questionnaire across its vasomotor, psychosocial, physical, and sexual domains. Domain scores range from 1 to 8, with higher scores indicating greater symptom-related bother and poorer quality of life.","Baseline and Weeks 4, 8, and 12",[18,21,25,28,31,34,37,40,43,46,49,52,55,58],{"measure":19,"description":20,"timeFrame":12},"Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score","Change in sleep quality assessed using the PSQI. Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.",{"measure":22,"description":23,"timeFrame":24},"Number of Participants With Adverse Events","Number of participants experiencing at least one adverse event during the intervention.","Throughout the 12-week intervention",{"measure":26,"description":27,"timeFrame":16},"Change From Baseline in Body Weight","Change in body weight, measured in kilograms.",{"measure":29,"description":30,"timeFrame":16},"Change From Baseline in Body Mass Index","Change in body mass index, calculated as body weight in kilograms divided by height in meters squared.",{"measure":32,"description":33,"timeFrame":12},"Change From Baseline in Fasting Blood Glucose","Change in fasting blood glucose concentration, measured in mg\u002FdL.",{"measure":35,"description":36,"timeFrame":12},"Change From Baseline in Glycated Hemoglobin (HbA1c)","Change in glycated hemoglobin, expressed as a percentage.",{"measure":38,"description":39,"timeFrame":24},"Study Product Adherence","Percentage of prescribed study product doses taken during the intervention, assessed using returned product counts and adherence records.",{"measure":41,"description":42,"timeFrame":16},"Change From Baseline in Waist Circumference","Change in waist circumference, measured in centimeters.",{"measure":44,"description":45,"timeFrame":16},"Change From Baseline in Hip Circumference","Change in hip circumference, measured in centimeters.",{"measure":47,"description":48,"timeFrame":12},"Change From Baseline in State Anxiety Score","Change in state anxiety assessed using the Spanish State-Trait Anxiety Inventory (STAI). The state anxiety subscale contains 20 items scored from 0 to 3. After reverse scoring the appropriate items, total scores range from 0 to 60, with higher scores indicating greater anxiety.",{"measure":50,"description":51,"timeFrame":12},"Change From Baseline in Self-Rated Health on the EQ Visual Analogue Scale","Change in self-rated health assessed using the EQ visual analogue scale. Scores range from 0, representing the worst imaginable health, to 100, representing the best imaginable health. Higher scores indicate better self-rated health.",{"measure":53,"description":54,"timeFrame":12},"Change From Baseline in Physical Activity Assessed by IPAQ Short Form","Change from baseline in total physical activity assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), referring to activity during the previous seven days.\n\nTotal physical activity is calculated by summing walking, moderate-intensity, and vigorous-intensity activity, expressed as metabolic equivalent of task (MET)-minutes per week. The minimum value is 0 MET-minutes\u002Fweek. This continuous measure has no fixed maximum before application of the questionnaire's data-processing rules.\n\nHigher values indicate greater reported physical activity; they do not directly represent better or worse health outcomes.",{"measure":56,"description":57,"timeFrame":12},"Change From Baseline in 14-Item Mediterranean Diet Adherence Score","Change in adherence to the Mediterranean diet assessed using the 14-item questionnaire included in the study assessment battery. Each item is scored 0 or 1 according to its specified dietary criterion. Total scores range from 0 to 14, with higher scores indicating greater adherence to the Mediterranean diet.",{"measure":59,"description":60,"timeFrame":12},"Change From Baseline in Perceived Deficits Questionnaire-Depression 5-Item (PDQ-D-5) Total Score","Change in subjective cognitive difficulties assessed using the PDQ-D-5. The questionnaire contains five items assessing the frequency of perceived cognitive difficulties over the previous seven days. Each item is scored from 0 to 4, yielding a total score from 0 to 20. Higher scores indicate greater perceived cognitive difficulties.",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":61,"timePerspective":61,"maskingInfo":67},"RANDOMIZED","PARALLEL","Participants will be randomly assigned to one of two parallel groups to receive either a plant extract-based dietary supplement or placebo daily for 12 weeks.","TREATMENT",{"masking":68,"maskingDescription":61,"whoMasked":69},"DOUBLE",[70,71],"PARTICIPANT","INVESTIGATOR","This is a randomized, double-blind, placebo-controlled, parallel-group study conducted at EIEH Clinic in Elche, Spain.\n\nApproximately 120 women aged 42 to 60 years with late perimenopause or early postmenopause and at least five moderate or severe hot flashes per day during the screening period will be enrolled.\n\nParticipation will last approximately 14 weeks, comprising a two-week screening period followed by a 12-week intervention period. Participants will attend six in-person visits and will be randomly assigned to one of two groups: a plant extract-based dietary supplement or placebo. The assigned product will be taken daily throughout the intervention. Participants and the research team will remain blinded to treatment allocation during the study.\n\nHot flash and night sweat frequency and severity will be recorded using a daily diary. Menopausal symptoms and menopause-related quality of life will be assessed using the Menopause Rating Scale (MRS) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). Additional assessments will include sleep quality, emotional well-being, perceived cognitive function, physical activity, dietary habits, and adherence to the Mediterranean diet.\n\nBody composition will be assessed by bioelectrical impedance analysis, together with body weight, height, body mass index, and body circumferences. Blood samples will be collected at baseline and at the end of the intervention to assess selected hormonal, biochemical, and hematological parameters.\n\nAdherence will be monitored through study product counts and adherence records. Adverse events and other relevant incidents will be recorded throughout the study. Changes over time will be compared between the intervention and placebo groups.",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Dietary Supplement","EXPERIMENTAL","Participants will receive a plant extract-based dietary supplement daily for 12 weeks.",[79],"Dietary Supplement: Plant Extract-Based Dietary Supplement",{"label":81,"type":82,"description":83,"interventionNames":84},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo daily for 12 weeks.",[85],"Other: Placebo",[87,92],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":61},"DIETARY_SUPPLEMENT","Plant Extract-Based Dietary Supplement","A dietary supplement containing plant extracts, supplied by Monteloeder and administered daily for 12 weeks.",[75],{"type":6,"name":81,"description":93,"armGroupLabels":94,"otherNames":61},"Placebo administered daily for 12 weeks as the control intervention.",[81],[96],{"name":97,"role":98,"phone":99,"phoneExt":61,"email":100},"ALEJANDRO MARTÍNEZ RODRÍGUEZ","CONTACT","696210163","amartinezrodriguez@ua.es",[102],{"facility":103,"status":104,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"European Institute Of Exercise and Health","RECRUITING","Elche","Alicante","03202","Spain","ES",{"type":111,"coordinates":112},"Point",[113,114],-0.70107,38.26218,{"lat":114,"lon":113},[117],{"name":97,"role":98,"phone":99,"phoneExt":61,"email":61},{"type":119,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Alejandro Martínez-Rodríguez","Full Professor of Health Sciences","100659304","effects-of-a-dietary-supplement-in-women-with-late-perimenopause-or-early-postmenopause-100659304",false,"NCT07863973","Effects of a Dietary Supplement in Women With Late Perimenopause or Early Postmenopause","Study of the Effect of a Dietary Supplement on Health Indicators in Women With Late Perimenopause and Early Postmenopause","Inclusion Criteria:\n\n* Women aged 42 to 60 years.\n* Late perimenopause or early postmenopause.\n* Amenorrhea for at least 3 months and no more than 10 years since menopause.\n* At least five moderate or severe hot flashes per day during the screening period.\n* Body mass index of 35 kg\u002Fm² or less.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Serious uncontrolled diseases.\n* Treatments that may interfere with the assessment of the primary outcome measures.\n* Known allergy or intolerance to any component of the study product.\n* Concurrent participation in another clinical trial.\n* Any circumstance that, in the investigator's judgment, would hinder compliance with the study protocol.",true,"FEMALE","42 Years","60 Years",{"count":134,"type":135},120,"ESTIMATED","INTERVENTIONAL",[138],"NA","This study will evaluate the effects of a plant extract-based dietary supplement on menopausal symptoms and health indicators in women with late perimenopause or early postmenopause.\n\nApproximately 120 women aged 42 to 60 years will be randomly assigned to receive either the dietary supplement or a placebo daily for 12 weeks. Neither the participants nor the research team will know the assigned treatment during the study.\n\nAssessments will include the frequency and severity of hot flashes and night sweats, menopausal symptoms, quality of life, sleep quality, emotional well-being, body composition, and selected laboratory parameters.",[141,142,143],"Perimenopause","Postmenopause","Hot Flashes",[145,146,147,148,149,150],"Menopause","Vasomotor symptoms","Night sweats","Dietary supplement","Plant extracts","Menopause-related quality of life","2026-10-07",{"date":153,"type":154},"2026-10-13","ACTUAL",{"date":156,"type":135},"2026-11-01",{"date":158,"type":135},"2027-03-31",{"name":5,"class":6},1]