[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658107":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":73,"studyPopulation":66,"armGroups":74,"interventions":95,"overallOfficials":66,"centralContacts":109,"locations":115,"responsibleParty":129,"collaborators":133,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":66,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":158,"overallStatus":163,"whyStopped":66,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Universidad de Almeria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Handgrip Strength","Change from baseline in mean bilateral handgrip strength (kg) to the end of the fasting period, assessed using a handgrip dynamometer. For each hand, three trials will be performed and averaged. The mean values obtained for the right and left hands will then be averaged to obtain one bilateral handgrip strength value per participant.","Baseline and Day 4 to Day 28 (final fasting day, depending on participant)",[14,17,20,23,26,29,32,35,38,41,44,47,50,53,56,60,63],{"measure":15,"description":16,"timeFrame":12},"Fasting Blood Glucose","Change in fasting blood glucose concentration (mg\u002FdL) from baseline to the end of the fasting period.",{"measure":18,"description":19,"timeFrame":12},"Fasting Insulin","Change in fasting insulin concentration (µIU\u002FmL) from baseline to the end of the fasting period.",{"measure":21,"description":22,"timeFrame":12},"LDL Cholesterol","Change in low-density lipoprotein cholesterol concentration (mg\u002FdL) from baseline to the end of the fasting period.",{"measure":24,"description":25,"timeFrame":12},"HDL Cholesterol","Change in high-density lipoprotein cholesterol concentration (mg\u002FdL) from baseline to the end of the fasting period.",{"measure":27,"description":28,"timeFrame":12},"Triglycerides","Change in triglyceride concentration (mg\u002FdL) from baseline to the end of the fasting period.",{"measure":30,"description":31,"timeFrame":12},"C-Reactive Protein","Change in C-reactive protein concentration (mg\u002FL) from baseline to the end of the fasting period.",{"measure":33,"description":34,"timeFrame":12},"Five-Times Sit-to-Stand Test","Change in the time required to complete five consecutive sit-to-stand repetitions (seconds) from baseline to the end of the fasting period.",{"measure":36,"description":37,"timeFrame":12},"30-Second Sit-to-Stand Test","Change in the number of complete sit-to-stand repetitions performed within 30 seconds (repetitions) from baseline to the end of the fasting period.",{"measure":39,"description":40,"timeFrame":12},"Blood Lactate Response to the 30-Second Sit-to-Stand Test","Change from baseline to the end of the fasting period in the blood lactate response to the 30-second sit-to-stand test, calculated as post-exercise blood lactate minus pre-exercise blood lactate (Δ lactate; mmol\u002FL) at each assessment.",{"measure":42,"description":43,"timeFrame":12},"Total Body Fat Mass","Change in total body fat mass (kg) from baseline to the end of the fasting period, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":45,"description":46,"timeFrame":12},"Body Fat Percentage","Change in total body fat percentage (%) from baseline to the end of the fasting period, assessed by DXA.",{"measure":48,"description":49,"timeFrame":12},"Total Lean Mass","Change in total lean mass (kg) from baseline to the end of the fasting period, assessed by DXA.",{"measure":51,"description":52,"timeFrame":12},"Visceral Adipose Tissue Fat Mass","Change in visceral adipose tissue (VAT) fat mass (g) from baseline to the end of the fasting period, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":54,"description":55,"timeFrame":12},"Subcutaneous Adipose Tissue Fat Mass","Change in subcutaneous adipose tissue (SAT) fat mass (g) from baseline to the end of the fasting period, assessed by dual-energy X-ray absorptiometry (DXA).",{"measure":57,"description":58,"timeFrame":59},"Physical Activity - International Physical Activity Questionnaire (IPAQ)","Change in self-reported physical activity (MET-min\u002Fweek) from baseline to the end of the fasting period, assessed using the International Physical Activity Questionnaire (IPAQ). Higher MET-min\u002Fweek values indicate greater physical activity.","Baseline; Day 4 to Day 28 (final fasting day, depending on participant); and 30 days after the final fasting day",{"measure":61,"description":62,"timeFrame":59},"Pittsburgh Sleep Quality Index (PSQI)","Change from baseline in subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21 points). Higher scores indicate poorer subjective sleep quality.",{"measure":64,"description":65,"timeFrame":59},"Health-Related Quality of Life - SF-36","Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The eight domains assessed are physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (each scored from 0 to 100 points). Higher scores indicate better health status.",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":70,"primaryPurpose":6,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NON_RANDOMIZED","PARALLEL","This study will consist of a non-randomized clinical trial including adults undergoing the Buchinger Wilhelmi prolonged fasting program. Participants will self-select whether to complete an online exercise program before the clinical stay and whether to participate in a supervised exercise program specifically designed for the fasting period. This will result in four parallel groups: prolonged fasting alone; prolonged fasting plus supervised exercise; online exercise followed by prolonged fasting alone; or online exercise followed by prolonged fasting plus supervised exercise. During prolonged fasting, participants will receive approximately 200-250 kcal\u002Fday. Participants will be enrolled prospectively and continuously as they attend the clinic.",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE","Prolonged fasting induces substantial metabolic adaptations, including increased ketone body production and changes in glucose and lipid metabolism, and has been associated with improvements in cardiometabolic health and body composition. However, fasting may also be accompanied by fatigue, sleep disturbances, and changes in well-being that can affect physical function and quality of life during the intervention.\n\nExercise is a potent non-pharmacological strategy for improving physical fitness, body composition, cardiometabolic health, sleep, and quality of life. Combining exercise with prolonged fasting may provide complementary benefits by enhancing fasting-induced metabolic adaptations while helping to maintain physical function and well-being. The timing of exercise may also be relevant, as exercise performed before the fasting period may influence the physiological response to fasting, while exercise performed during fasting may directly interact with fasting-induced changes in substrate utilization and energy metabolism.\n\nBased on this rationale, the main hypothesis is that structured exercise performed before and\u002For during prolonged fasting enhances the physiological and metabolic effects of fasting while improving physical fitness, sleep, and quality of life. The main objective is to determine the independent and combined effects of exercise performed before and during the Buchinger Wilhelmi prolonged fasting program on physical fitness, body composition, cardiometabolic health, sleep, and health-related quality of life.\n\nThe study will involve adults undergoing the Buchinger Wilhelmi prolonged fasting program as part of their clinical stay. Participants will choose whether to complete an online exercise program before attending the clinic and whether to participate in a supervised exercise program specifically designed for the fasting period during their clinical stay. These choices will result in four study conditions: (1) online exercise followed by prolonged fasting alone; (2) online exercise followed by prolonged fasting combined with supervised exercise; (3) prolonged fasting alone; and (4) prolonged fasting combined with supervised exercise. Allocation to these conditions will not be randomized. During fasting, participants will receive approximately 200-250 kcal\u002Fday and may participate in the activities routinely available at the clinic.\n\nBefore and after the intervention, participants will undergo physiological and physical fitness assessments. Blood samples will be collected to assess cardiometabolic and metabolic responses, including glucose and lipid metabolism and ketone production. Body composition will be assessed using bioelectrical impedance analysis, and physical fitness will include handgrip and lower-limb strength assessments. Sleep will be evaluated objectively using accelerometry and subjectively using the Pittsburgh Sleep Quality Index, while health-related quality of life will be assessed using the SF-36 questionnaire. These assessments are consistent with those specified in the study protocol.\n\nBy comparing the four study conditions, the study aims to determine whether structured exercise performed before and\u002For during prolonged fasting enhances fasting-induced metabolic adaptations and improves physical fitness, body composition, sleep, and health-related quality of life.",[75,81,86,91],{"label":76,"type":77,"description":78,"interventionNames":79},"Prolonged fasting","EXPERIMENTAL","Participants will undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days without completing the study-specific online exercise program before the clinical stay or the supervised exercise program during fasting.",[80],"Behavioral: Buchinger Wilhelmi prolonged fasting",{"label":82,"type":77,"description":83,"interventionNames":84},"Prolonged fasting + supervised exercise","Participants will undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days and participate in the study-specific supervised exercise program during the fasting period. Participants will not complete the online exercise program before the clinical stay.",[80,85],"Behavioral: Supervised exercise program during prolonged fasting",{"label":87,"type":77,"description":88,"interventionNames":89},"Online exercise + prolonged fasting","Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days without participating in the supervised exercise program during fasting.",[80,90],"Behavioral: Online exercise program",{"label":92,"type":77,"description":93,"interventionNames":94},"Online exercise + prolonged fasting + supervised exercise","Participants will complete a 21-day study-specific online exercise program before the clinical stay and subsequently undergo the Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days combined with the study-specific supervised exercise program during fasting.",[80,90,85],[96,101,105],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":66},"BEHAVIORAL","Buchinger Wilhelmi prolonged fasting","Participants will undergo the medically supervised Buchinger Wilhelmi prolonged fasting program for at least 4 consecutive days. During fasting, participants will receive approximately 200-250 kcal\u002Fday, primarily from vegetable juices and vegetable broth, together with non-caloric fluids.",[87,92,76,82],{"type":97,"name":102,"description":103,"armGroupLabels":104,"otherNames":66},"Online exercise program","Participants will complete a 21-day study-specific remotely delivered exercise program before admission to the Buchinger Wilhelmi Clinic. The program provides structured exercise training before the prolonged fasting period.",[87,92],{"type":97,"name":106,"description":107,"armGroupLabels":108,"otherNames":66},"Supervised exercise program during prolonged fasting","Participants will complete a study-specific supervised exercise program during the prolonged fasting period at the Buchinger Wilhelmi Clinic. Exercise sessions will be conducted under professional supervision and adapted to participants' individual physical capacity.",[92,82],[110],{"name":111,"role":112,"phone":113,"phoneExt":66,"email":114},"Borja Martínez Téllez, PhD","CONTACT","+34 950215334","borjammt@ual.es",[116],{"facility":117,"status":66,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":66},"Universidad de Almería","Almería","Almeria","04131","Spain","ES",{"type":124,"coordinates":125},"Point",[126,127],-2.45974,36.83814,{"lat":127,"lon":126},{"type":130,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"PRINCIPAL_INVESTIGATOR","Borja Martínez Tellez","Principal Investigator",[134],{"name":135,"class":6},"Buchinger Wilhelmi Development & Holding GmbH","100658107","effects-of-the-buchinger-wilhelmi-fasting-program-and-exercise-on-physical-fitness-and-sleep-quality-100658107",false,"NCT07847658","Effects of the Buchinger Wilhelmi Fasting Program and Exercise on Physical Fitness and Sleep Quality","Fasting Meets Fitness: Unlocking the Synergy Between BW Protocol, Exercise, and Sleep Quality - A Clinical Study","FASTEX","Inclusion Criteria:\n\n* Men and women aged 18-80 years.\n* Undergoing the Buchinger Wilhelmi prolonged fasting program at the Buchinger Wilhelmi Clinic in Marbella for at least 4 consecutive days.\n* Medically eligible to undergo prolonged fasting and to complete the study assessments.\n* For participants choosing an exercise condition, medically eligible to participate in the corresponding exercise program.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Any medical condition or functional limitation that significantly restricts mobility or prevents safe completion of the study assessments or, when applicable, the exercise program.\n* Pregnancy or breastfeeding.\n* Cognitive or communication impairment that prevents adequate understanding of the study procedures or provision of informed consent.\n* Concurrent participation in another interventional study that could interfere with the study procedures or outcomes.",true,"ALL","18 Years","80 Years",{"count":149,"type":150},100,"ESTIMATED","INTERVENTIONAL",[153],"NA","Type of Study: Clinical Trial\n\nGoal: The goal of this clinical trial is to investigate whether combining the Buchinger Wilhelmi prolonged fasting program with a structured exercise program can improve physical fitness, body composition, cardiometabolic health, sleep quality, and health-related quality of life. The study will also investigate metabolic responses to prolonged fasting and whether these responses are influenced by exercise.\n\nParticipant Population\u002FHealth Conditions: The study will involve adults attending the Buchinger Wilhelmi Clinic who undergo the prolonged fasting program and meet the study eligibility criteria.\n\nMain Questions:\n\n* Does structured exercise performed before and\u002For during prolonged fasting enhance its effects on physical fitness, body composition, and cardiometabolic health?\n* Does structured exercise improve sleep quality and health-related quality of life during prolonged fasting?\n\nParticipants Will:\n\n* Undergo the Buchinger Wilhelmi prolonged fasting program.\n* Choose whether to complete an online exercise program before the clinical stay and\u002For a supervised exercise program during fasting.\n* Undergo physiological, physical fitness, and body composition assessments before and after the intervention.\n* Provide blood samples to assess cardiometabolic and metabolic responses.\n* Complete assessments of sleep and health-related quality of life.\n\nComparison Groups: Researchers will compare the four study conditions to determine whether structured exercise performed before and\u002For during prolonged fasting enhances the physiological, metabolic, and functional effects of the Buchinger Wilhelmi fasting program.",[156,157],"Fasting Conditions","Metabolic Health",[76,159,160,161,162],"Buchinger Wilhelmi fasting","Physical exercise","Cardiometabolic health","Physical fitness","NOT_YET_RECRUITING","2026-09-23",{"date":166,"type":167},"2026-09-29","ACTUAL",{"date":169,"type":150},"2027-01",{"date":171,"type":150},"2030-01",{"name":5,"class":6},1]