[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657337":3},{"organization":4,"outcomesModule":7,"designInfo":79,"detailedDescription":88,"studyPopulation":78,"armGroups":89,"interventions":109,"overallOfficials":78,"centralContacts":117,"locations":123,"responsibleParty":136,"collaborators":140,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":78,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":177,"whyStopped":78,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"Universidad de Almeria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":78},[9],{"measure":10,"description":11,"timeFrame":12},"iBAT adipocyte composition and gene expression (snRNA-seq)","Change in adipocyte subpopulations and gene expression in dorsocervical iBAT assessed by single-nucleus RNA sequencing (snRNA-seq)","1 week",[14,17,20,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75],{"measure":15,"description":16,"timeFrame":12},"iBAT mitochondrial respiration (Oroboros O2k).","Change in mitochondrial respiration in dorsocervical iBAT assessed by high-resolution respirometry.",{"measure":18,"description":19,"timeFrame":12},"iBAT protein expression (Western blot)","Change in protein expression in dorsocervical iBAT assessed by Western blot, including markers related to thermogenesis and mitochondrial function.",{"measure":21,"description":22,"timeFrame":23},"Total Body Fat Mass","Change in total body fat mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).","5 weeks",{"measure":25,"description":26,"timeFrame":23},"Body Fat Percentage","Change in total body fat percentage (%) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":28,"description":29,"timeFrame":23},"Resting Metabolic Rate","Change in resting metabolic rate (kcal\u002Fday) from baseline, assessed by indirect calorimetry.",{"measure":31,"description":32,"timeFrame":23},"Cardiorespiratory Fitness - Peak Oxygen Uptake (VO₂peak)","Change from baseline in peak oxygen uptake (VO₂peak; mL\u002Fkg\u002Fmin), assessed during exercise testing with breath-by-breath gas exchange analysis.",{"measure":34,"description":35,"timeFrame":23},"LDL Cholesterol","Change in fasting LDL cholesterol (mg\u002FdL) from baseline, assessed in blood samples.",{"measure":37,"description":38,"timeFrame":23},"Urinary Urea Nitrogen","Change from baseline in urinary urea nitrogen (UUN) concentration (mg\u002FdL), assessed in urine samples as a marker of protein metabolism.",{"measure":40,"description":41,"timeFrame":23},"Gut microbiota","Change in gut microbiota composition assessed in fecal samples.",{"measure":43,"description":44,"timeFrame":23},"Fat-Free Mass","Change in total fat-free mass (kg) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":46,"description":47,"timeFrame":23},"Visceral Adipose Tissue (VAT) Fat Mass","Change in visceral adipose tissue (VAT) fat mass (g) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":49,"description":50,"timeFrame":23},"Subcutaneous Adipose Tissue (SAT) Fat Mass","Change in subcutaneous adipose tissue (SAT) fat mass (g) from baseline, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":52,"description":53,"timeFrame":23},"Fat Oxidation Rate at Rest","Change in resting fat oxidation rate (g\u002Fmin) from baseline, calculated from oxygen consumption (VO₂) and carbon dioxide production (VCO₂) measured by indirect calorimetry.",{"measure":55,"description":56,"timeFrame":23},"Carbohydrate Oxidation Rate at Rest","Change in resting carbohydrate oxidation rate (g\u002Fmin) from baseline, calculated from oxygen consumption (VO₂) and carbon dioxide production (VCO₂) measured by indirect calorimetry.",{"measure":58,"description":59,"timeFrame":23},"HDL Cholesterol","Change in fasting HDL cholesterol (mg\u002FdL) from baseline, assessed in blood samples.",{"measure":61,"description":62,"timeFrame":23},"Fasting Glucose","Change in fasting blood glucose (mg\u002FdL) from baseline.",{"measure":64,"description":65,"timeFrame":23},"Fasting Insulin","Change in fasting insulin concentration (µIU\u002FmL) from baseline, assessed in blood samples.",{"measure":67,"description":68,"timeFrame":23},"Triglycerides","Change in fasting triglyceride concentration (mg\u002FdL) from baseline, assessed in blood samples.",{"measure":70,"description":71,"timeFrame":23},"C-Reactive Protein (CRP)","Change in C-reactive protein concentration (mg\u002FL) from baseline, assessed in blood samples.",{"measure":73,"description":74,"timeFrame":23},"Fat Oxidation During Exercise","Change from baseline in fat oxidation rate (g\u002Fmin) during exercise, estimated by indirect calorimetry using a COSMED Quark metabolic cart.",{"measure":76,"description":77,"timeFrame":23},"Carbohydrate Oxidation During Exercise","Change from baseline in carbohydrate oxidation rate (g\u002Fmin) during exercise, estimated by indirect calorimetry using a COSMED Quark metabolic cart.",null,{"allocation":80,"interventionModel":81,"interventionModelDescription":82,"primaryPurpose":83,"observationalModel":78,"timePerspective":78,"maskingInfo":84},"RANDOMIZED","PARALLEL","This study will consist of a randomized controlled trial in which 60 postmenopausal women with a BMI ≥27 kg\u002Fm² will be randomly assigned (1:1:1:1) to a control group (n=15; maintaining their usual lifestyle), an aerobic exercise group (n=15; supervised exercise for 60-90 minutes\u002Fday at 65% heart rate reserve), a prolonged fasting group (n=15; approximately 600 kcal\u002Fday), or a combined exercise plus fasting group (n=15; completing both interventions). All interventions will last five consecutive days.","BASIC_SCIENCE",{"masking":85,"maskingDescription":78,"whoMasked":86},"SINGLE",[87],"INVESTIGATOR","Postmenopause is associated with a substantial increase in cardiometabolic risk, partly driven by the decline in estrogen levels and alterations in cellular energy metabolism. Mitochondrial dysfunction has been documented in skeletal muscle of postmenopausal women and is associated with metabolic inflexibility, reduced fat oxidation, ectopic fat accumulation, and insulin resistance. However, whether mitochondrial dysfunction is also present in adipose tissue of postmenopausal women, and whether it can be reversed through lifestyle interventions, remains largely unknown.\n\nBrown adipose tissue (BAT) is a mitochondria-rich and metabolically active tissue involved in thermogenesis and substrate utilization. Although human BAT has traditionally been studied in the supraclavicular region, emerging evidence from our research group suggests the presence of a metabolically active adipose tissue depot in the dorsocervical region, referred to as interscapular brown adipose tissue (iBAT). Preliminary observations indicate that this depot may have distinct metabolic characteristics. However, iBAT has not yet been characterized in postmenopausal women.\n\nAerobic exercise is a potent non-pharmacological stimulus for mitochondrial remodeling and improves mitochondrial biogenesis and oxidative capacity. Exercise-derived lactate may also promote adipose tissue browning and mitochondrial remodeling. Prolonged fasting induces profound metabolic adaptations characterized by increased fat mobilization and changes in substrate utilization. Preliminary data from our group suggest that five days of prolonged fasting substantially increase fat oxidation during exercise, providing a rationale for investigating whether fasting and exercise may have complementary effects on mitochondrial function and metabolic flexibility.\n\nBased on this rationale, the main hypothesis of EMPOWER-BAT is that iBAT in postmenopausal women presents mitochondrial dysfunction and that aerobic exercise, five-day prolonged fasting, and their combination can improve mitochondrial function through lactate-related signaling pathways, leading to enhanced whole-body metabolic flexibility. The main objective is to characterize mitochondrial function in iBAT and determine the effects of these interventions on iBAT mitochondrial function and metabolic flexibility.\n\nEMPOWER-BAT is a randomized controlled trial involving 60 postmenopausal women aged 45-65 years with a body mass index ≥25 kg\u002Fm². Participants will be randomized (1:1:1:1) into four groups: a control group maintaining its usual lifestyle; an aerobic exercise group performing supervised exercise for 60-90 minutes at 65% of heart rate reserve; a prolonged fasting group following a medically supervised fasting protocol providing approximately 600 kcal\u002Fday; or a combined group completing both exercise and fasting. All interventions will last five consecutive days.\n\nBefore and after the intervention, iBAT biopsies will be collected from the dorsocervical region to assess mitochondrial function and adipocyte characteristics. Metabolic and physiological assessments will include indirect calorimetry at rest and during exercise, body composition, cardiorespiratory fitness, and blood and urine biomarkers. Continuous glucose and ketone monitoring will also be performed during the intervention. Four weeks later, metabolic and physiological assessments will be repeated to determine whether changes in metabolic flexibility are maintained after participants return to their usual lifestyle.",[90,94,100,105],{"label":91,"type":92,"description":93,"interventionNames":78},"Control","NO_INTERVENTION","n=15; maintaining their usual lifestyle without changes to diet or physical activity; Total 5 days",{"label":95,"type":96,"description":97,"interventionNames":98},"Aerobic exercise","EXPERIMENTAL","n=15; receiving supervised aerobic exercise for 60-90 minutes\u002Fday at 65% of heart rate reserve; Total 5 days",[99],"Behavioral: Aerobic exercise",{"label":101,"type":96,"description":102,"interventionNames":103},"Prolonged fasting","n=15; following a prolonged fasting protocol providing approximately 600 kcal\u002Fday; Total 5 days",[104],"Behavioral: Prolonged fasting",{"label":106,"type":96,"description":107,"interventionNames":108},"Aerobic exercise + prolonged fasting","n=15; receiving supervised aerobic exercise for 60-90 minutes\u002Fday at 65% of heart rate reserve and prolonged fasting providing approximately 600 kcal\u002Fday; Total 5 days",[99,104],[110,114],{"type":111,"name":95,"description":112,"armGroupLabels":113,"otherNames":78},"BEHAVIORAL","Participants will perform supervised aerobic exercise for 60-90 minutes per day at 65% of heart rate reserve on 5 consecutive days.",[95,106],{"type":111,"name":101,"description":115,"armGroupLabels":116,"otherNames":78},"Participants will follow a medically supervised prolonged fasting protocol providing approximately 600 kcal\u002Fday for five consecutive days.",[106,101],[118],{"name":119,"role":120,"phone":121,"phoneExt":78,"email":122},"Borja Martínez Téllez, PhD","CONTACT","+34 950215334","borjammt@ual.es",[124],{"facility":125,"status":78,"city":126,"state":126,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":135,"contacts":78},"Universidad de Almería","Almería","04131","Spain","ES",{"type":131,"coordinates":132},"Point",[133,134],-2.45974,36.83814,{"lat":134,"lon":133},{"type":137,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":78,"oldOrganization":78},"PRINCIPAL_INVESTIGATOR","Borja Martínez Tellez","Principal Investigator",[141,143,145],{"name":142,"class":6},"Leiden University Medical Center",{"name":144,"class":6},"ETH Zurich (Switzerland)",{"name":146,"class":6},"Buchinger Wilhelmi Development & Holding GmbH","100657337","exercise-and-prolonged-fasting-to-improve-brown-adipose-tissue-function-in-postmenopausal-women-100657337",false,"NCT07837752","Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women","Exercise and Prolonged Fasting to Improve Interscapular Brown Fat Mitochondrial Function and Enhance Metabolic Flexibility in Postmenopausal Women (EMPOWER-BAT)","EMPOWER-BAT","Inclusion Criteria:\n\n* Women aged 45 to 65 years.\n* Postmenopausal status, defined as ≥ 12 consecutive months without menstruation.\n* Women with amenorrhea shorter than 12 months will be included if their follicle-stimulating hormone levels are \\>30IU\u002Fliter.\n* BMI between ≥25 kg\u002Fm2.\n* Sedentary or low-active (not meeting physical activity guidelines).\n* Willing to be randomized to any of the four groups.\n* Able and willing to adhere to all study procedures and show availabity in their schedule.\n* Must be willing to have biological samples stored for future research.\n\nExclusion Criteria:\n\n* Diabetes mellitus (determined based on fasting glucose levels defined by ADA criteria).\n* Any other active endocrine disease (thyroid disease, any signs of Cushing's syndrome, adrenal disease and lipid-associated disorders such as familial hypercholesterolemia).\n* Any cardiac disease (i.e., ischemic cardiac disease, arrhythmias, severe heart failure).\n* Use of medication known to influence glucose and\u002For lipid metabolism or brown fat activity (e.g., beta-blockers, antidepressants, corticosteroids).\n* Current or recent (past 6 months) use of hormone replacement therapy, including systemic estrogen therapy (oral or transdermal), combined estrogen-progestin therapy, tibolone, or selective estrogen receptor modulators.\n* Clinically relevant abnormalities in clinical chemistry or electrocardiogram at screening (to be judged by the study physician).\n* A first-degree family member with sudden cardiac death.\n* Any chronic renal or hepatic disease.\n* Abuse of alcohol or other substances.",true,"FEMALE","45 Years","65 Years",{"count":160,"type":161},60,"ESTIMATED","INTERVENTIONAL",[164],"NA","Type of Study: Clinical Trial\n\nGoal: The goal of this clinical trial is to investigate mitochondrial function in interscapular brown adipose tissue (iBAT) in postmenopausal women and determine whether aerobic exercise, prolonged fasting, or their combination can improve iBAT mitochondrial function and whole-body metabolic flexibility.\n\nParticipant Population\u002FHealth Conditions: The study will involve 60 postmenopausal women aged 45-65 years living with overweight or obesity.\n\nMain Questions: The main questions this study aims to answer are:\n\n* What are the mitochondrial function and cellular characteristics of iBAT in postmenopausal women?\n* Can aerobic exercise or five-day prolonged fasting improve mitochondrial function in iBAT and whole-body metabolic flexibility?\n* Does combining aerobic exercise with prolonged fasting produce greater metabolic adaptations than either intervention alone?\n* Are improvements in metabolic flexibility maintained four weeks after the intervention?\n\nParticipants Will:\n\nBe randomized into one of four groups: control, aerobic exercise, prolonged fasting, or combined aerobic exercise plus prolonged fasting.\n\nFollow their assigned intervention for five consecutive days. Undergo metabolic and physiological assessments before and after the intervention and again four weeks later.\n\nProvide dorsocervical adipose tissue biopsies and biological samples to investigate mitochondrial function, adipocyte characteristics, and metabolic adaptations.\n\nComparison Group: Researchers will compare the effects of aerobic exercise, prolonged fasting, and their combination with a control condition to determine their effects on iBAT mitochondrial function and whole-body metabolic flexibility.",[167,168],"Cardiometabolic Diseases","Postmenopause",[170,171,172,173,174,175,176],"Brown adipose tissue","thermogenesis","women","postmenopause","exercise","fasting","metabolic flexibility","NOT_YET_RECRUITING","2026-09-17",{"date":180,"type":181},"2026-09-23","ACTUAL",{"date":183,"type":161},"2027-09-01",{"date":185,"type":161},"2029-09",{"name":5,"class":6},1]