[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612262":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Valencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise + nutritional supplement (Gr 1: EXNS)","EXPERIMENTAL","Participants in this group will receive a daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks.",[13],"Dietary Supplement: Exercise + nutritional supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Exercise + placebo supplement (Gr 2: EXPLA)","PLACEBO_COMPARATOR","Participants in this group will receive a placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.",[19],"Dietary Supplement: Exercise + placebo supplement",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Exercise + nutritional supplement","Participants in this group will receive an oral daily dose of the natural-origin nutritional supplement in combination with a supervised functional exercise program (3 sessions per week, 45-60 minutes each) for 10 weeks, composed by three exercise blocks: 1) joint mobility and postural control exercises block, 2) functional strength block with three sets of two explosive strength exercises using elastic bands at 70% of 1RM and, 3) coordination and agility exercises block.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Exercise + placebo supplement","Participants in this group will receive an oral placebo supplement identical in appearance to the active supplement, together with the same functional exercise program for 10 weeks.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Juan Carlos Colado Sánchez, Chair full professor","CONTACT","(9639) 83470","juan.colado@uv.es",[38],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Physical activity and Sport Science Faculty, Valencia, Valencia 46010","RECRUITING","Valencia","46010","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],-0.37966,39.47391,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":36},{"name":33,"role":54,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Juan C. Colado","Professor of Physical Education","100612262","impact-of-funcional-exercise-and-supplementation-in-perimenopausal-womens-health-100612262",false,"NCT07251296","Impact of Funcional Exercise and Supplementation in Perimenopausal Women's Health","Effects of a Nutritional Supplement and Physical Exercise on the Psycho-emotional, Cognitive, Functional, and Neuroendocrine Health of Perimenopausal Women.","Inclusion Criteria:\n\n* Women aged between 45 and 65 years.\n* In the menopausal transition (defined by irregular menstrual cycles and typical symptoms within the past year) or postmenopause.\n* Score ≥ 8 on the Menopause Rating Scale (MRS), indicating moderate menopausal symptom intensity.\n* Regular nighttime sleep and not engaged in shift work.\n* Low physical activity level: less than 150 minutes per week of moderate or vigorous physical activity, as assessed by the short-form IPAQ or a similar questionnaire.\n* Body mass index (BMI) between 18.5 and 35 kg\u002Fm².\n* Sufficient functional and cognitive capacity to participate in supervised physical exercise and follow the study protocol.\n* Signed informed consent and availability to attend all scheduled sessions and assessments.\n\nExclusion Criteria:\n\n* Current or recent (within the last 3 months) use of hormone replacement therapy (HRT).\n* Surgical, induced, or early menopause (before age 40).\n* Current treatment with medications that may affect mood, sleep, or vasomotor symptoms, including: antidepressants (SSRIs, SNRIs, tricyclics); anxiolytics or hypnotics; phytoestrogens, isoflavones, or other over-the-counter hormonal supplements.\n* Medical diagnosis of severe or uncontrolled chronic diseases, including cardiovascular, respiratory (particularly sleep apnea), metabolic, active oncological, neurological, severe autoimmune, or psychiatric disorders.\n* Regular use within the past 3 months of nutritional or sports supplements that may interfere with study outcomes (e.g., creatine, protein, omega-3, adaptogens, etc.).\n* Medical contraindications for moderate-to-vigorous physical exercise, as determined by the PAR-Q+ questionnaire and\u002For updated medical report.\n* Simultaneous participation in another clinical trial or intervention program involving drugs, supplements, or structured physical exercise of any kind.\n* Known allergy or intolerance to any component of the nutritional supplement to be administered.","FEMALE","45 Years","65 Years",{"count":69,"type":70},90,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn whether a natural-origin nutritional supplement, combined with a functional exercise program, can improve psycho-emotional, cognitive, functional, and neuroendocrine health in perimenopausal women. The study will also help determine the safety of this combined intervention.\n\nThe main questions it aims to answer are:\n\n* Does the combined intervention improve mood, sleep quality, menopausal symptoms, and cognitive performance?\n* Does it enhance physical function and neuroendocrine regulation?\n\nResearchers will compare the supplement to a placebo. All participants will follow the same supervised functional exercise program.\n\nParticipants will:\n\n* Take a daily nutritional supplement or placebo for 10 weeks\n* Attend three weekly supervised functional exercise sessions (45-60 minutes each)\n* Complete pre- and post-intervention evaluations including questionnaires, physical and cognitive tests, and blood samples for biomarker analysis.",[76,77],"Perimenopause","Aging",[76,79,80,81,82,83,84,85,86,87,88],"nutritional supplement","Functional exercise","Psycho-emotional health","Cognitive function","Non-pharmacological interevention","Randomized controlled trial","Physical function","variable resistance training","Neuroendocrine biomarkers","Sleep and mood regulation","2025-12-15",{"date":91,"type":92},"2025-12-22","ACTUAL",{"date":89,"type":92},{"date":95,"type":70},"2026-07",{"name":5,"class":6},1]