[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589794":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":94,"collaborators":98,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":43,"eligibilityCriteria":113,"healthyVolunteers":110,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":43,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Strict Vegetarian Diet, Regular Physical Exercise, and Placebo Administration","PLACEBO_COMPARATOR","Participants in this group will follow a strict vegetarian diet (SVD) combined with regular physical exercise (RPE) for four weeks. The diet will consist of plant-based foods rich in fiber and bioactive compounds, with a controlled macronutrient distribution. Physical activity will include structured aerobic and resistance exercises supervised by a physical educator. Instead of probiotic supplementation, participants will receive a placebo administered in the same manner as the probiotic group to ensure blinding.",[13],"Dietary Supplement: Placebo Administration",{"label":15,"type":16,"description":17,"interventionNames":18},"Strict Vegetarian Diet, Regular Physical Exercise, and Probiotic Supplementation","EXPERIMENTAL","Participants in this group will receive the same strict vegetarian diet (SVD) and regular physical exercise (RPE) as Arm 1. In addition, they will take a probiotic supplement containing a combination of four different strains, administered twice daily for four weeks. This group aims to assess the potential additional metabolic benefits of probiotic supplementation in individuals with type 2 diabetes.",[19],"Dietary Supplement: Probiotic Supplementation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Probiotic Supplementation","Participants will follow the same strict vegetarian diet and regular physical exercise as in Intervention 1. Additionally, they will receive a probiotic supplement, taken twice daily for four weeks. This aims to evaluate the metabolic impact of probiotics in type 2 diabetes.",[15],[27],"Probiotic",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo Administration","Participants will follow a strictly plant-based diet rich in fiber and bioactive compounds, with controlled macronutrient distribution. Regular physical exercise includes supervised aerobic and resistance training sessions. The intervention lasts four weeks. Instead of probiotic supplementation, participants will receive a placebo, administered in the same manner as the probiotic group to maintain blinding.",[9],[33],"Placebo",[35],{"name":36,"affiliation":37,"role":38},"Maria E. R. Silva, MD, PhD","University of Sao Paulo","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+55 11 3061-7258",null,"mbeth@usp.br",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Edna C. Vieira, Master of Science in Nutrition","+55 11 98795-1544","ednavieira@gmail.com",[50],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Universidade de São Paulo (USP)","RECRUITING","São Paulo","01246-903","Brazil","BR",{"type":58,"coordinates":59},"Point",[60,61],-46.63611,-23.5475,{"lat":61,"lon":60},[64,68,70,72,74,76,78,80,82,84,86,88,90,92],{"name":65,"role":41,"phone":66,"phoneExt":43,"email":67},"Benicio T. S. Pereira, MD","+5511996464421","benicio.pereira@adventistas.org",{"name":46,"role":41,"phone":69,"phoneExt":43,"email":48},"+5511987951544",{"name":46,"role":71,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"name":73,"role":71,"phone":43,"phoneExt":43,"email":43},"Benício T. S. Pereira, MD",{"name":75,"role":71,"phone":43,"phoneExt":43,"email":43},"José J. Farias Neto, MD",{"name":77,"role":71,"phone":43,"phoneExt":43,"email":43},"Daniela T. Kanno, MD",{"name":79,"role":71,"phone":43,"phoneExt":43,"email":43},"Aritania S. Santos, MS, PhD",{"name":81,"role":71,"phone":43,"phoneExt":43,"email":43},"Samuel K. Shinjo, MS, PhD, Postdoc",{"name":83,"role":71,"phone":43,"phoneExt":43,"email":43},"Denise C. Paranagua-Vezozzo, MD, PhD",{"name":85,"role":71,"phone":43,"phoneExt":43,"email":43},"Maria A. Mendes, MS, PhD, Postdoc",{"name":87,"role":71,"phone":43,"phoneExt":43,"email":43},"Marisa Passarelli, MS, PhD, Postdoc",{"name":89,"role":71,"phone":43,"phoneExt":43,"email":43},"Lucas A. M. Franco, MS, PhD",{"name":91,"role":38,"phone":43,"phoneExt":43,"email":43},"Maria E. R. Silva, MD, MS, PhD",{"name":93,"role":71,"phone":43,"phoneExt":43,"email":43},"Marcia C. T. Martins, MS, PhD, Postdoc",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Maria Elizabeth Rossi da Silva","MD, PhD",[99,102,105],{"name":100,"class":101},"Clínica e Spa Vida Natural","UNKNOWN",{"name":103,"class":104},"Probiotical S.p.A.","INDUSTRY",{"name":106,"class":107},"Conselho Nacional de Desenvolvimento Científico e Tecnológico","OTHER_GOV","100589794","therapeutic-strategies-for-type-2-diabetes-based-on-lifestyle-changes-plant-based-diet-and-physical-exercise-100589794",false,"NCT06959043","Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise","Inclusion Criteria:\n\n* Have a medical diagnosis of type 2 diabetes for a maximum of 5 years.\n* Be omnivorous; Have a Body Mass Index (BMI) ≥ 25 kg\u002Fm2 and \\\u003C 40 kg\u002Fm2;\n* Be between the ages of 45 and 70, both genders.\n* Women should be in the postmenopausal stage;\n* Use no more than three hypoglycemic medications in total;\n* Have the availability for a four-week consecutive hospitalization at CSVN.\n\nExclusion Criteria:\n\n* Be using insulin, anti-obesity medications, antibiotics, and\u002For probiotic supplements in the 2 months preceding data collection;\n* Use of alcohol or tobacco;\n* Have limited mobility and a previous diagnosis of cardiopulmonary diseases;\n* Report current or previous (within the past two months) diarrhea during screening;\n* Have liver or kidney failure and uncontrolled endocrine disorders (hypothyroidism, hypogonadism, and adrenal insufficiency);\n* Have eating disorders or have undergone bariatric surgery.","ALL","45 Years","70 Years",{"count":118,"type":119},60,"ESTIMATED","INTERVENTIONAL",[122],"NA","The study evaluates the impact of a strict vegetarian diet combined with regular physical exercise and the use of probiotics on metabolic, inflammatory, and epigenetic parameters in patients with type 2 diabetes. It aims to determine the influence of these interventions on gut microbiota, glycemic control, body composition, insulin resistance, and quality of life.",[125,126,127,128],"Type 2 Diabetes Mellitus (T2DM)","Insulin Resistance","Inflamation","Gut Microbiomes",[130,126,127,131,132,133,134,135],"Type 2 Diabetes Mellitus","Metabolic Syndrome","Physical Exercise","Gut Microbiome","Plant-based Diet","Lifestyle Interventions","2025-05-13",{"date":138,"type":139},"2025-05-18","ACTUAL",{"date":141,"type":139},"2022-11-22",{"date":143,"type":119},"2026-12",{"name":96,"class":6},1]