protocolSection identificationModule nctId: NCT06333223, orgStudyIdInfo id: LSC 23/ 396, briefTitle: Polyphenols and Probiotics to Improve Menopausal Symptoms Via the Gut-Brain Axis, acronym: SYMPTOGUT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12-18, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Roehampton, class: OTHER, collaborators name: King's College, descriptionModule briefSummary: Menopause is one of the most significant lifecourse challenges for women. The decline in female sex hormones, in particular estrogen, during menopause leads to an increased risk in cardiometabolic diseases, and a decrease in quality of life due to symptoms such as low mood, anxiety, hot flushes and difficulty sleeping. As life expectancy continues to increase, on average, women will spend one third of their life in the postmenopausal period. Increasing evidence suggests that the gut microbiota plays a key role in menopause-related symptoms and conditions, being one of the main regulators of circulating sex hormones. Menopause has been linked to gut dysbiosis and lower gut microbial diversity, therefore nutritional strategies targeting the gut microbiome may be an effective approach to improve women's health during menopause. Both (poly)phenols and probiotics are promising candidates for the prevention and treatment of menopausal symptoms via different mechanisms, including the modulation of the gut-brain axis, while emerging evidence indicates that using both together may be a better approach than traditional carbohydrate-based synbiotics.To our knowledge, the efficacy of a (poly)phenol based synbiotic targeting the gut microbiome for improvement of menopausal symptoms has not been investigated so far., conditionsModule conditions: Menopause, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Arm 1: Mixture of (Poly)phenols and a probiotic supplement Arm 2: (Poly)phenols and maltodextrin (placebo), primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Mixture of (Poly)phenols and a probiotic supplement, interventions name: Placebo comparator, outcomesModule primaryOutcomes measure: Change in blood chemistry levels, secondaryOutcomes measure: Change in BMI (body mass index) Scores, secondaryOutcomes measure: Change in the gut microbiota diversity, secondaryOutcomes measure: Change in dietary habits, secondaryOutcomes measure: Change in Quality IPAQ, secondaryOutcomes measure: Change in inflammatory biomarkes, eligibilityModule sex: FEMALE, minimumAge: 48 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton, status: RECRUITING, city: London, state: UK, zip: SW15 4JD, country: United Kingdom, contacts name: Adele Costabile, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Adele Costabile, status: RECRUITING, city: London, zip: SW145JD, country: United Kingdom, contacts name: Adele Costabile, Prof, role: CONTACT, contacts name: Zicheng Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False