[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perimenopausal-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perimenopausal-women":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,62,92,109,143,180,201,234,268,301],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054036","nutritional-supplementation-on-physiological-and-metabolic-markers-in-females-100054036",false,"NCT07615777","Nutritional Supplementation on Physiological and Metabolic Markers in Females","A Pilot Study Investigating the Effects of a Nutritional Supplement on Physiological and Metabolic Markers in 38-55-year-old Females","Inclusion Criteria:\n\n* Assigned sex at birth is female\n* Aged 38-55 years\n* Experiencing irregular menstrual cycles but not amenorrheic for more than 12 months or have at least one of the following recent symptoms (i.e., from 38 years onwards): (1) hot flushes, (2) sleep disturbances, (3) mood swings, (4) concentration difficulties, (5) bloating or (6) weight gain.\n\n  * Willing to avoid taking other food supplements during the study period\n  * Able to provide written informed consent\n\nExclusion Criteria:\n\n* Diabetes\n* BMI \\\u003C18.5 kg\u002Fm2\n* Pregnant or trying to get pregnant\n* No active cancer or cancer within last 5 years\n* Total Hysterectomy\n* Known allergies to cinnamon extract, chromium, berberine, myo-inositol\n* Currently taking part in research, or have done within the last 3 months\n* Diagnosed autoimmune diseases\n* Diagnosed hypoglycemia",true,"FEMALE","38 Years","55 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if a 12-week nutritional supplement can result in significant changes in the body composition of 38-55-year-old females. The main questions it aims to answer are:\n\n* Does a 12-week nutritional supplementation with myo-inositol, berberine, cinnamon, and chromium lead to significant changes in body composition (e.g. body mass index, body fat composition) in females aged 38-55 compared to placebo?\n* Does a 12-week nutritional supplementation with myo-inositol, berberine, cinnamon, and chromium lead to significant changes in small molecules (metabolites) in plasma and urine, menopause-related symptoms, and physical performance (e.g. grip strength) in females aged 38-55 compared to placebo? Researchers will compare the nutritional supplement to a placebo (a look-alike substance that contains no nutritional supplement) to see if the intervention works to change body composition in females aged 38-55.\n\nParticipants will:\n\n* Sign a consent form before any procedures begin\n* Attend two visits to the clinical research facility at Southampton General Hospital over 12 weeks.\n* Fast before visit's and provide blood and urine samples at each visit\n* Undergo measurements at each visit, including waist and hip circumferences, grip and leg strength, and body composition.\n* Complete questionnaires about general health, menopause-related changes, alcohol consumption, physical activity, and diet.\n* Take 1 capsule 3 times a day at the onset of a meal (once in the morning, once at midday, and once in the evening) for the first 10 days.\n* Take 3 capsules 3 times a day at the onset of a meal (once in the morning, once at midday, and once in the evening) from day 11 to day 84.\n* Record supplement intake in a daily compliance diary during the study",[28,29],"Perimenopausal Women","Body Composition Changes",[31,32,33,34],"Perimenopause","menopause","metabolism","metabolomics","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-07-09",{"date":43,"type":22},"2026-12",{"name":45,"class":46},"University of Southampton","OTHER",1,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":26,"conditions":52,"keywords":53,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":61,"locationsCount":47},"100640067",{"count":21,"type":22},[25],[28,29],[31,32,33,34],"NOT_YET_RECRUITING","2026-05-29",{"date":57,"type":39},"2026-06-03",{"date":59,"type":22},"2026-06-01",{"date":43,"type":22},{"name":45,"class":46},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":16,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":47},"100611580","12-week-multi-vitaminmineral-supplementation-on-peri-menopause-symptoms-cognition-sleep-and-psychological-well-being-100611580","NCT07242430","12-week Multi-vitamin\u002FMineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being.","Effects of 12-week Multi-vitamin\u002FMineral Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial","Inclusion Criteria:\n\n* Self-assess as healthy\n* Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)\n\nExclusion Criteria:\n\n* Post-menopausal\n* Lactating, pregnant or seeking to become pregnant\n* Nut Allergy\n* Taken antidepressant\u002Fantianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.\n* Habitual multi-vitamin\u002Fmineral supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.\n* Menopause symptoms have been medically induced.\n* Receiving gender-affirming hormone therapy.","40 Years","60 Years",{"count":72,"type":22},58,[25],"Perimenopause is a stage of transition into menopause that is marked by menopausal symptoms while menstruation is still taking place. Perimenopause symptoms include mood changes, anxiety, sleep disruptions, hot flushes, night sweats, fatigue, and cognitive challenges. The frequency and severity of these symptoms can seriously impair women's quality of life. Even if the public's awareness on menopause has increased, there are still a lot of unanswered questions. A connection between nutrition and menopause management has been proposed in earlier research. However, there is limited research in this field, and women frequently turn to social media for supplement recommendations in order to deal with menopause-related issues.\n\nVitamins and minerals such as vitamin D and calcium are recommended by the European Menopause and Andropause Society and there is limited evidence to suggests that soy and herbals may have a beneficial effect on menopausal symptoms, but more research is needed.\n\nThe aim of this study is to investigate the effects of 12-weeks multi-vitamin\u002Fmineral and herbal extract-containing supplement on menopause symptoms, memory and concentration, sleep, and psychological well-being.",[31,28,76],"Perimenopause, Climacteric Syndrome",[78,79,80,81,82,83],"perimenopause","cognition","psychological wellbeing","sleep","magnesium","memory","2026-05-28",{"date":55,"type":39},{"date":87,"type":39},"2026-04-07",{"date":89,"type":22},"2026-08-01",{"name":91,"class":46},"Northumbria University",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":16,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":47},"100611076","12-week-magnesium-supplementation-on-peri-menopause-symptoms-cognition-sleep-and-psychological-well-being-100611076","NCT07235878","12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep, and Psychological Well-being","Effects of 12-week Magnesium Supplementation on Peri-menopause Symptoms, Cognition, Sleep and Psychological Wellbeing - a Randomised, Placebo-controlled Trial","Inclusion Criteria:\n\n* Self-assess as healthy\n* Report experiencing troublesome peri-menopause symptoms in the past 6 months but not post-menopausal (defined as 12 months with no periods)\n\nExclusion Criteria:\n\n* Post-menopausal\n* Lactating, pregnant or seeking to become pregnant\n* Nut Allergy\n* Taken antidepressant\u002Fantianxiety medication or other medication with strong likelihood for effects on cognition or sleep in the past 6 months.\n* Habitual magnesium supplementation (defined as more than 3 consecutive days or 4 days in total). Will be excluded unless washout for 1 month.\n* Menopause symptoms have been medically induced.\n* Receiving gender-affirming hormone therapy.",{"count":72,"type":22},[25],"Perimenopause is a transition phase into menopause, characterised by menopausal symptoms while menstrual periods are still occurring. Common symptoms of perimenopause include hot flushes, night sweats, mood swings, anxiety, sleep disturbances, fatigue, and cognitive difficulties. These symptoms can be both frequent and intense, with the potential to significantly deteriorate women's quality of life. Despite an increase in public discourse around menopause, there are still large gaps in knowledge. Previous literature has suggested a relationship between diet and menopause management. However, studies in this area are limited and women often rely on social media for advice on supplements to address menopause complaints. One supplement that has received a lot of attention with purported benefits for menopause is magnesium, primarily due to its links to energy and or\u002Fsleep, however no studies have explored psychological effects of magnesium supplementation in perimenopause.\n\nThe aim of this study is to explore the effects of 12-weeks magnesium supplementation on perimenopause symptoms, cognition, sleep, and psychological well-being.",[31,28,76],[78,79,80,81,82,83],{"date":55,"type":39},{"date":106,"type":39},"2025-12-09",{"date":89,"type":22},{"name":91,"class":46},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":117,"maxAge":70,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":47},"100641020","probiotic-intake-and-perimenopausal-psychological-assessments-100641020","NCT07590999","Probiotic Intake and Perimenopausal Psychological Assessments","The Effects of a Probiotic on Emotional Processing, Cognition, and the Gut Microbiome in Perimenopausal Women","PIPPA","Inclusion Criteria:\n\n* Female at birth\n* You are aged 45-60 years and in perimenopause (determined by changes in menstrual bleeding patterns (such as changes in cycle length of 7 days or longer in either direction from what is normal for you), AND vasomotor symptoms (e.g., hot flushes and sweats) AND mild to moderate mood or cognitive disturbances, or joint and muscle pain over the previous 12 months)\n* You are willing and able to give informed consent for participation in the study\n* You are sufficiently fluent in English to understand and complete tasks\n* You are at least 12 months post-natal\n* Willing to withhold from having grapefruit juice\n\nExclusion Criteria:\n\n* Currently receive or seek treatment for any mental health condition\n* Have a BMI \\>=30 OR \\\u003C=18.5\n* Have lost or gained more than 10% of body weight in a short period (e.g., 6 months), as this can affect mood and cognition\n* Currently using hormonal contraception or have used hormonal contraception in the last 6 months\n* Have had gender reassignment surgery or gender-affirming hormone therapy\n* Had a head injury causing concussion or unconsciousness in the past 6 months\n* Participated in other studies that may influence mood, cognition, or gut health in the last three months\n* Are currently diagnosed with and\u002For treated for psychiatric or neurological disorders\n* Are on perimenopausal hormone replacement therapy (HRT) (e.g., estrogen, progesterone, testosterone) or other hormone-modulating medications (e.g., GLP-1 agonists, thyroxine replacement), as these can impact mood and cognitive functions\n* Currently use statins or have used statins in the last 6 months, as these may impact mood and cognitive functions\n* Participated in any other study with the same tasks in the last year\n* Currently use medications that influence cognition or mood, such as antidepressants, anxiolytics, antipsychotics, stimulants, mood-stabilizers, or cognitive-enhancing drugs\n* Have chronic or severe gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, celiac disease, or severe acid reflux; treatment with e.g., corticosteroids, antacids), as these conditions and treatments can affect the gut microbiota and immune responses differently from healthy individuals\n* Have a compromised immune system\n* Currently smoke, vape, or use any other nicotine products\n* Have a current diagnosis of cognitive impairment or neurodegenerative disorders (e.g., mild cognitive impairment, dementia), as these conditions could confound cognitive assessments.\n* Have severe medical conditions requiring ongoing medication that may independently affect cognition or mood (e.g., diabetes)\n* Currently or recently used antibiotics (last 3 months), as antibiotics may alter gut microbiota and interfere with probiotic effects\n* Currently or recently used probiotics or prebiotics or consumed fermented products (e.g., kimchi, kombucha, sauerkraut, kefir, etc.) on a regular basis (last 3 months), which might interfere with the study intervention\n* Have known allergies or intolerances to probiotics or components in the probiotic supplement.\n* Have substance abuse or dependence (e.g., alcohol, recreational drugs) that may affect mood and cognition.\n* Have Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (Long COVID)\n* Have had a hysterectomy\n* Are pregnant or lactating, as hormonal changes associated with these states could confound results.\n* Score of 20 or above on PHQ-9 depression questionnaire, indicating severe depression\n* Score of \\>1 on PHQ-9 suicidality item, indicating significant suicidality (as assessed by medical on-site professionals","45 Years",{"count":119,"type":22},106,[25],"Recent evidence suggests multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum have been found to enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improve cognitive functions, such as memory and concentration, in healthy participants. By administering computer-based tasks, questionnaires and checking biological measures (cortisol, immune markers, blood metabolites, gut microbiota) using blood and faecal samples, this experimental medicine study aims to investigate whether a probiotic supplement has an effect on emotional processing and cognition in perimenopausal women. We also aim to study changes in gut bacteria from stool samples before and after taking the supplement to see if any microbiome changes are associated with any effects in emotional processing, cognitive function, and biological markers.",[123,31,124,28],"Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations","Perimenopause-Related Depression",[78,32,126,127,128,129,130,131,132,133],"gut microbiome and perimenopause","cognition and perimenopause","emotional processing and perimenopause","mood and perimenopause","gut microbiome and cognition","probiotics","probiotic","gut microbiome","2026-05-12",{"date":136,"type":39},"2026-05-15",{"date":138,"type":39},"2025-11-12",{"date":140,"type":22},"2027-06-30",{"name":142,"class":46},"University of Oxford",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":16,"sex":17,"minAge":151,"maxAge":70,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":47},"100631491","effects-of-a-6-months-fiber--and-polyphenol-rich-diet-on-brain-inflammatory-processes-in-perimenopausal-women-living-with-overweight-or-obesity-100631491","NCT07501377","Effects of a 6-months Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Perimenopausal Women Living With Overweight or Obesity","Effects of a Fiber- and Polyphenol-rich Diet on Brain Inflammatory Processes in Obesity","INFLAME","Inclusion Criteria:\n\n* STRAW+10 -1 or -2\n* BMI \\> 25 or WHR \\>= 0.85\n* hsCRP \\> 1 mg\u002Fl\n* no MRI contra-indication\n* written informed consent\n\nExclusion Criteria:\n\n* occurrence of a clinically relevant psychiatric disease in the last 12 months (e.g., depression, substance abuse, eating disorder, schizophrenia)\n* type 1 diabetes\n* previous bariatric\u002Fgastric surgery\n* pregnancy or breastfeeding woman\n* severe untreated disease, cancer treatment last 12 months, any chronic gastric tract disease (IBS, Morbus Crohn, Heliobacter pylori Infection etc.) or any chronic inflammatory disease\n* Polycystic ovary syndrome, total ovarectomy\n* Intake of antibiotics in past 3 months, intake of inulin (\\>5g\u002Fday) or polyphenol supplementation (\\>50mg\u002Fday) in past 3 months","35 Years",{"count":153,"type":22},120,[25],"People living with obesity have a higher risk of late-life cognitive decline and developing dementia. In women, the risk of cognitive decline may further raise during the menopausal transition, a period of substantial hormonal and metabolic changes.\n\nRecent studies suggest that a healthy diet could help to prevent neurocognitive disorders by reducing inflammatory processes in the body and brain. Emerging evidence further indicates that the gut-brain axis and the intestinal microbiome play a crucial role in mediating this effect, through metabolic, immune, neuronal and vascular routes. Modifying the gut microbiota may thus counteract the heightened systemic inflammation seen in obesity and during menopausal transition to eventually benefit brain health.\n\nSpecifically, plant-based nutirents, such as fibre and polyphenols, have microbiome-changing, anti-inflammatory and neuroprotective properties that may slow brain aging and neuro-inflammation. However, evidence from human interventional studies and knowledge on the underlying mechanisms remain scarce.\n\nThis randomized controlled trial will therefore test whether altering gut bacteria through six months of daily intake of a personalized \"polybiotic\" dietary formula, compared to placebo, improves markers of brain health in women during the perimenopausal transition that are living with overweight or obesity. We plan to enroll 120 women aged 35-60 with overweight\u002Fobesity and elevated inflammatory blood markers, randomized to: intervention (7.5 or 15 g inulin, plus 200 mg resveratrol and 320 mg quercetin per day in powder form with main meals) or control (isocaloric maltodextrin). Exclusions include type 1 diabetes, current psychiatric\u002Fgastrointestinal disorders, and magentic resonance imaging (MRI) contraindications.\n\nBefore and after 26 weeks, participants will undergo brain MRI to assess inflammation-related brain markers, neuropsychological testing, anthropometric measurements, they will fill in a set of questionnaires and donate stool and blood. Gut bacteria will be profiled by next-generation sequencing; metabolites will be measured in blood and stool. The primary outcome is a proxy of neuroinflammation in the white matter assessed using diffusion-weighted MRI. Secondary analyses will examine blood-brain-barrier permeability and other functional and structural MRI measures, including MR spectoscropy. Mechanistic links among changes in inflammatory markers, microbiota composition, and short-chain fatty acids will be explored using path and network models.\n\nThis study may help to develop novel prevention and treatment strategies to mitigate obesity-related cognitive decline via the gut-brain axis.",[157,28],"Overweight and\u002For Obesity",[159,160,161,162,163,164,165,166,167,168,169,170],"neuroinflammation","obesity","overweight","menopausal transition","gut-brain axis","diet","diffusion-weighted MRI","cognitive decline","brain aging","MR spectroscopy","prevention","open science","2026-03-26",{"date":173,"type":39},"2026-03-30",{"date":175,"type":39},"2026-03-19",{"date":177,"type":22},"2030-12-31",{"name":179,"class":46},"Max Planck Institute for Human Cognitive and Brain Sciences",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":16,"sex":17,"minAge":69,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":4},"100625252","phase-4-menopausal-hormones-and-sympathetic-activation-100625252","NCT07420218","Menopausal Hormones and Sympathetic Activation","Impact of FSH and Estradiol on Sympathetic Function in Menopausal Women","Inclusion Criteria:\n\n* Perimenopausal (based on changes in menstrual cycle)\n* Ages 40-58 years\n\nExclusion Criteria:\n\n* History of CVD, blood clots, stroke\n* History of Cancer\n* History of Liver or Kidney disease\n* History of Neurological disease\n* Diabetes\n* BMI\\>35kg\u002Fm2\n* Pregnant, planning on becoming pregnant, or breast feeding\n* Allergy to Latex\n* Use of Tobacco\n* Hysterectomy\n* Blood pressure \\>140\u002F90 mmHg\n* Current or prior use of hormone replacement therapy (within 3 mo)","58 Years",{"count":21,"type":22},[190],"PHASE4","The purpose of this study is to understand how changes in menopausal hormones like estradiol and follicle-stimulating hormone (FSH) impact sympathetic nervous system function. To do so, the investigators will use a medication to control the production of estradiol and FSH, and in some participants, add-back estradiol to isolate its effects. The investigators will measure sympathetic activation centrally (in the brain using MRI), peripherally in the nervous system, and also examine adrenergic receptor mediated control of vascular function.",[28],"2026-03-25",{"date":195,"type":39},"2026-03-27",{"date":197,"type":22},"2026-09-01",{"date":177,"type":22},{"name":200,"class":46},"University of Delaware",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":208,"targetDuration":4,"studyType":210,"phases":4,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100592890","caramel-retrospective-study-for-personalized-risk-assessment-of-cardiovascular-disease-in-menopausal-and-perimenopausal-women-using-real-world-data-100592890","NCT06999317","CARAMEL: Retrospective Study for Personalized Risk Assessment of Cardiovascular Disease in Menopausal and Perimenopausal Women Using Real World Data","CARAMEL RS","Inclusion Criteria:\n\nSelf-identified as female in the electronic health record (EHR). Age between 40 and 60 years at the time of data collection\u002Findex date. Availability of at least 5-6 years of retrospective data in the EHR, depending on the research objective.\n\nAt least one healthcare encounter (visit, imaging, lab test, diagnosis, etc.) within the defined age range.\n\nFor imaging substudies (e.g., RO3-RO5): availability of at least one relevant imaging test (e.g., DXA, digital mammography, cMRI, CCTA, US) during the age range.\n\nFor signal-based analysis (RO6): presence of ECG monitoring data from implanted devices and at least 2 years of follow-up.\n\nExclusion Criteria:\n\nPrior diagnosis of cardiovascular disease before the observation window (only applicable to specific ROs, e.g., RO2, RO4).\n\nInsufficient data quality or missing key variables needed for modeling (e.g., absence of blood pressure or lipid profile).\n\nPatients with incomplete or inconsistent records (e.g., duplicate IDs, mismatched time frames).\n\nFor signal-based RO6: hospitalizations or diagnoses unrelated to cardiovascular health that may bias AI model training.",{"count":209,"type":22},1500000,"OBSERVATIONAL","This retrospective observational study, part of the EU-funded CARAMEL project, aims to develop and validate personalized cardiovascular disease (CVD) risk assessment models specifically designed for menopausal and perimenopausal women (ages 40-60). The study leverages Real World Data (RWD) collected from multiple international clinical partners, including electronic health records (EHR), diagnostic imaging data, and signal data.\n\nThe main objective is to improve the prediction of CVD precursors such as hypertension and dyslipidemia, as well as mid- and long-term risk of CVD events, through advanced artificial intelligence (AI) models. These models will be trained on multimodal data to capture complex, individualized risk trajectories that current risk calculators fail to address, particularly in women. Special focus is placed on under-researched, women-specific risk factors and their interactions with traditional predictors.\n\nThe study includes several research objectives: (1) predicting the onset of hypertension and dyslipidemia using EHR data; (2) modeling the long-term risk of fatal and non-fatal cardiovascular events and disease trajectories; (3) identifying novel imaging biomarkers from routine screening tests such as mammography, DXA, ultrasound, and cardiac MRI; (4) developing multimodal prediction models combining imaging and clinical data; (5) creating automated AI tools for imaging biomarker extraction; and (6) using signal data from cardiac devices to predict disease progression and events.\n\nThe study population consists of middle-aged women with retrospective data available across different health systems. The expected outcome is a validated set of stratified, personalized CVD risk models that can support targeted prevention strategies and enable more equitable, sex-specific care. This will contribute to reducing the burden of CVD in women and addressing critical gaps in early detection, clinical decision-making, and health policy.\n\nThis project has received funding from the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement No 101156210.",[213,214,28,215],"Cardiovascular Risk Factors","Menopausal Women","Real World Data",[217,218,219,220,221,222,223,224],"Cardiovascular Disease","Cardiovascular risk factors","Menopausal women","Perimenopausal women","real world data","personalised prevention","computational modelling","women-specific risks","2026-01-13",{"date":227,"type":39},"2026-01-15",{"date":229,"type":22},"2026-03-01",{"date":231,"type":22},"2028-04-30",{"name":233,"class":46},"Hospital Universitario Virgen Macarena",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":16,"sex":17,"minAge":69,"maxAge":19,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":47},"100591106","impact-of-lean-pork-on-endothelial-function-in-perimenopause-100591106","NCT06976112","Impact of Lean Pork on Endothelial Function in Perimenopause","Effects of Lean Pork Intake on Endothelial Function and Vasomotor Symptoms in Perimenopausal Women","LEAP","Inclusion Criteria:\n\n* Are female\n* Are between 40 and 55 years of age\n* Have a BMI (a number calculated from participant height and weight) between 28 and45 kg\u002Fm2\n* Are experiencing irregular menstrual cycles but have not gone longer than 12 consecutive months without a period\n* Are experiencing severe vasomotor (menopause) symptoms\n* Are doing less than 3 hours per week of structured exercise\n* Have systolic blood pressure between 120 and 140 mmHg and\u002For diastolic blood pressure between 80 and 90 mmHg\n* Have \"sugary\" hemoglobin called hemoglobin A1c less than or equal to 6.5%\n* Are willing and able to refrain from using oral mouth wash for the duration of the study because the alcohol in mouth wash inhibits nitrate synthesis\n* Are willing and able to comply with both the study diets\n* Are willing to collect blood for future research\n* Can read, speak, and understand English\n\nExclusion Criteria:\n\n* Hysterectomy (partial or full) or oophorectomy\n* Using hormone replacement therapy use and\u002For hormonal contraception use 6 months prior to study start\n* Has systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg)\n* Triglycerides ≥350 mg\u002FdL, low-density lipoprotein cholesterol (LDL-C) ≥190 mg\u002FdL, and\u002For taking a lipid-lowering medication -Diagnosed cardiovascular disease, diabetes (type 1 or 2), or endocrine- related disease (e.g. thyroid, PCOS), unstable gastrointestinal disease, kidney, liver, and\u002For pancreatic disease\n* Diagnosed cancer (except skin cancer) in the last 5 years\n* Taking \\>1 blood pressure medication and\u002For taking 1 blood pressure medication for \\\u003C3 months\n* Taking phosphodiesterase-5 inhibitors, anti-coagulants, corticosteroids, metformin, or insulin.\n* Weight change ≥6.6 pounds in the past 3 months, actively trying to lose weight, or unwilling to remain weight stable throughout the study\n* Current smoking or vaping, Binge and\u002For heavy drinker\n* Food allergies or other reasons preventing consumption of study foods with both study diets",{"count":243,"type":22},30,[25],"The goal of this study is to examine the impact of a diet high in fresh lean pork, compared to a plant-based diet, on cardiovascular function and vasomotor symptoms in perimenopausal women with overweight and obesity. The main questions it aims to answer are:\n\n1. How does a diet high in pork, compared to a plant-based diet, affects blood lipids, endothelial function, and blood pressure?\n2. How does a diet high in pork, compared to a plant-based diet, affects blood nitrate, cardiometabolic biomarkers, inflammatory biomarkers, and vasomotor symptoms?\n\nResearchers will compare the diet high in pork to a plant-based diet to see if pork helps improve cardiovascular and mesopause symptoms.\n\nParticipants will:\n\n* Consume both of the diets, each for 4 weeks, with a washout period between 2 and 6 weeks in between the diets trials\n* Visit the clinic 5 times with weekly meal pick ups during the diet trials\n* Undergo testing procedures including: weight and body composition, blood pressure and pulse, endothelial function using ultrasound of upper arm, microvascular blood flow, blood draws, physical activity measurements, and questionnaires.",[247,248,28,249],"Cardiovascular Outcome","Overweight and Obese Women","Vasomotor Symptoms (VMS)",[31,251,252,253,254,255,256,257,258],"Perimenopausal","Vasomotor Symptoms","VMS","Menopause","Cardiovascular Health","Blood pressure","Pork","Vegetarian","2025-11-26",{"date":261,"type":39},"2025-11-28",{"date":263,"type":39},"2025-08-01",{"date":265,"type":22},"2027-05",{"name":267,"class":46},"Pennington Biomedical Research Center",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":19,"enrollmentInfo":275,"targetDuration":4,"studyType":210,"phases":4,"briefSummary":277,"conditions":278,"keywords":285,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":47},"100594705","a-trial-to-investigate-the-accuracy-of-a-wearable-device-in-collecting-data-related-to-perimenopausal-symptoms-in-women-100594705","NCT07022925","A Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","An Observational Virtual Trial to Investigate the Accuracy of a Wearable Device in Collecting Data Related to Perimenopausal Symptoms in Women","Inclusion Criteria:\n\n1. Females between 35-55 years of age, inclusive\n2. Self-reported perimenopausal women experiencing hot flushes or night sweats\n3. Individuals of child-bearing potential must confirm they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:\n\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomy of partner at least 6 months prior to screening\n   * Abstinence\n4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, supplements\u002Fmedications, and sleep\n5. Provided voluntary and informed consent to participate in the study\n6. Generally healthy as determined by medical history with no unstable diagnosed medical conditions\n\nExclusion Criteria:\n\n1. Allergy or sensitivity to adhesive used for wearing the investigational device\n2. Self-reported use of a pacemaker\n3. Self-reported unstable diagnosed anxiety disorder\n4. Self-reported sleep disorder requiring medical treatment\n5. Self-reported skin conditions or sensitive skin around the area of application\n6. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study\n7. Alcohol intake average of ˃1 standard drink per day\n8. Alcohol or drug abuse within the last 12 months that has required treatment\n9. Current use of prescribed and\u002For over-the-counter (OTC) medications\u002Fsupplements that may impact data recorded by the investigational device (see Section 7.3)\n10. Participation in other clinical research studies 30 days prior to screening\n11. Individuals who are unable to give informed consent\n12. Any other condition or lifestyle factor, that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant",{"count":276,"type":22},110,"The goal of this observational study is to investigate the accuracy of the device in characterizing perimenopausal and menopausal symptoms including vasomotor symptoms, anxiety, sleep quality compared to self-reported symptoms via an app. The main question it aims to answer is:\n\nWhat is the accuracy of the developed algorithm from the investigational device compared to daily self-report via an app in characterizing perimenopausal symptoms?\n\nParticipants will be asked to wear IndentifyHer's wearable non-invasive sensor and complete a daily electronic diary and questionnaires on stress, anxiety, and sleep.",[31,279,280,28,281,282,283,284],"Perimenopausal Depression","Perimenopausal Insomnia","Menopausal Depression","Menopausal Hot Flashes","Menopausal and Postmenopausal Disorders","Menopausal Vasomotor Symptoms",[254,31,286,287,288,289,290],"Vasomotor symptoms","Hot flashes","IdentifyHer","Peri","Perimenopausal symptoms","2025-09-17",{"date":293,"type":39},"2025-09-18",{"date":295,"type":39},"2025-07-04",{"date":297,"type":22},"2025-10",{"name":299,"class":300},"IdentifyHer Limited","INDUSTRY",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":151,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":47},"100551677","self-acupressure-for-insomnia-in-perimenopausal-women-100551677","NCT06463197","Self-acupressure for Insomnia in Perimenopausal Women","Self-acupressure for Insomnia in Perimenopausal Women: A Pilot Randomized Controlled Trial","SAP","The inclusion criteria were as follows: (i) Chinese Hong Kong residents who were able to read Chinese; (ii) age 35 to 64 years; (iii) peri-menopausal women, defined as menstrual cycle irregularity (a change of 7 days or more in the menstrual cycle) or amenorrhea for no longer than 60 consecutive days, according to the recommendations from the Stages of Reproductive Aging Workshop; and (iv) with a current clinical DSM-5 diagnosis of insomnia disorder according to the Brief Insomnia Questionnaire. The criteria included having difficulties falling asleep, staying asleep, or early morning awakening with clinically significant consequences for daily life for at least 3 months. (v) An Insomnia Severity Index total score of at least 10 indicated that insomnia was present at the clinical level and (vi) Able to understand Chinese and Cantonese or Mandarin; (vii) willing to give informed consent and comply with the trial protocol.\n\nFor (iv) and (v), both the Brief Insomnia Questionnaire and Insomnia Severity Index were included as inclusion criteria. This is because the two scales have different purposes. Specifically, Brief Insomnia Questionnaire is used to confirm the participants fulfil the diagnostic criteria of DSM-5 insomnia disorder, while the Insomnia Severity Index is used to assess the severity of the insomnia symptoms and related daytime impairments.\n\nThe exclusion criteria are: (i) pregnancy; (ii) at significant suicide risk according to the rating by the Hamilton Depression Rating Scale item on suicide (score ≥3); (iii) no comorbid sleep disorders primarily requiring other treatments, such as sleep apnea or narcolepsy; (iv) change in the dose of their psychotropic drugs within 12 weeks prior to baseline, which would possibly indicate instability in their psychiatric condition; and (v) taking any antibiotics in 3 months before the baseline or any food containing probiotics, such as yogurt, in 7 days before the baseline.","64 Years",{"count":311,"type":22},40,[25],"Insomnia is a common complaint in peri-menopausal women. Acupressure might be a potential way to treat insomnia. Although acupressure can be self-administered, it is uncertain that whether the effects of self-administered acupressure are comparable to that of the practitioner-administered acupressure, due to the variability in patients' capability of mastering the acupressure technique and self-compliance. Previous studies seemingly suggested that self-administered acupressure may improve sleep quality, their conclusion on the efficacy of self-administered acupressure for insomnia was limited due to the lack of standardized subjective and objective sleep assessments and unclear diagnostic method of insomnia. To fill out this research gap, the proposed study will explore the effectiveness of self-acupressure for improving sleep in perimenopasual women using an RCT approach.",[315,28],"Insomnia",[317,318,319],"perimenopausal women","insomnia","sleep disorders","2024-06-12",{"date":322,"type":39},"2024-06-17",{"date":324,"type":22},"2024-07-01",{"date":326,"type":22},"2025-01-31",{"name":328,"class":46},"The Hong Kong Polytechnic University"]