[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perimenopause-related-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perimenopause-related-depression":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100638243","impact-of-a-novel-functional-snack-on-perimenopausal-symptoms-and-well-being-100638243",false,"NCT07599930","Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being","Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being: a Randomised, Double-blinded, Placebo-controlled, Crossover Trial","SWAP","Inclusion Criteria:\n\n* Adults aged 40 to 55\n* Score 14 or higher on the Menopause Rating Scale\n* For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.\n\nExclusion Criteria:\n\n* People who consume more than 15g of fibre a day\n* People who consume more than 2 cups of coffee or tea a day\n* People who consume more than 4 portions (portion = 80g) of fruits and vegetables a day\n* People who do not have any intolerances or allergies to the following:\n* Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts\n* Chia seeds\n* Pumpkin seeds\n* Sunflower seeds\n* Dates\n* Gluten\n* Dairy\n* Oats\n* Barley\n* Soya\n* People who smoke or vape or have smoked or vaped in the last 2 years\n* People who consume more than 21 drinks a week or have a history of excess alcohol intake\n* People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, including coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, cardiac arrhythmia, renal failure, cardiac failure, uncontrolled hypertension, cancer or major psychiatric or cognitive problems\n* People receiving drug treatment for lipid metabolisms (e.g., statins)\n* People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids) or aspirin\n* People taking antihypertensive drugs\n* People who take antibiotics or bacterial agents (Probiotics) within 1 month\n* People who take vitamin\u002Fdietary supplements within 1 month\n* Pregnant women, women ready for pregnancy, and nursing mothers\n* cardiac arrhythmia\n* renal failure\n* heart failure (NYHA II-IV)\n* diabetes mellitus\n* Malignant disease\n* People who have participated in a biomedical study within the past 3 months\n* Women who require hormone replacement therapy during the development of the protocol.",true,"FEMALE","40 Years","55 Years",{"count":22,"type":23},20,"ESTIMATED","INTERVENTIONAL",[26],"NA","This is a clinical trial aimed to investigate if a novel phytochemical and fibre-rich snack can improve perimenopausal symptoms and well-being in perimenopausal women aged 40-55 and not on hormone replacement therapy.\n\nHypothesis: The investigators hypothesise that the phytochemical and fibre-rich snack will improve perimenopausal symptoms via a gut microbiota mediated mechanism.\n\nMain research questions:\n\nDoes eating the snack every day lower menopause symptoms such as hot flushes, night sweats, mood changes, and sleep problems? Does the snack improve mood, stress, anxiety, sleep, and overall quality of life? Does the snack improve the balance of bacteria in the gut, and could this be part of how it helps symptoms?",[29,30,31,32,33,34],"Perimenopause","Perimenopause-Related Depression","Mood","Sleep","Quality of Life","Gut -Microbiota",[36,37,38,39,40,41],"phytochemical","fibre","mood","sleep","quality of life","gut","RECRUITING","2026-05-14",{"date":45,"type":46},"2026-05-20","ACTUAL",{"date":48,"type":46},"2026-04-24",{"date":50,"type":23},"2026-12",{"name":52,"class":53},"King's College London","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":24,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":54},"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","60 Years",{"count":66,"type":23},106,[26],"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.",[70,29,30,71],"Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations","Perimenopausal Women",[73,74,75,76,77,78,79,80,81,82],"perimenopause","menopause","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":85,"type":46},"2026-05-15",{"date":87,"type":46},"2025-11-12",{"date":89,"type":23},"2027-06-30",{"name":91,"class":53},"University of Oxford"]