[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054036":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Southampton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nutritional supplement","EXPERIMENTAL","Nutritional supplement:\n\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.",[13],"Dietary Supplement: Nutritional Supplement",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo:\n\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.",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Nutritional Supplement","Nutritional Supplement (myo-inositol, berberine, cinnamon, chromium) composed of 4 natural bioactives extracted from plants, including fruits, roots, barks, and grains.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo: Maltodextrin",[15],[31],{"name":32,"affiliation":5,"role":33},"Colleen S Deane, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+44 2381208664","c.s.deane@soton.ac.uk",{"name":40,"role":36,"phone":37,"phoneExt":26,"email":41},"Veronica F Santiago, PhD","V.F.Santiago@soton.ac.uk",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"NIHR Southampton Clinical Research Facility","RECRUITING","Southampton","Hampshire","SO16 6YD","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-1.40428,50.90395,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":26,"email":61},"Clinical Research Facility","02381204989","crfstudyteam@uhs.nhs.uk",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65],{"name":66,"class":67},"The Better Menopause","UNKNOWN","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":80,"type":81},80,"ESTIMATED","INTERVENTIONAL",[84],"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",[87,88],"Perimenopausal Women","Body Composition Changes",[90,91,92,93],"Perimenopause","menopause","metabolism","metabolomics","2026-07-10",{"date":96,"type":97},"2026-07-13","ACTUAL",{"date":99,"type":97},"2026-07-09",{"date":101,"type":81},"2026-12",{"name":5,"class":6},1]