[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651325":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":50,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Gadjah Mada University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"low-energy high-protein diet intervention","EXPERIMENTAL","Participants in this single-arm study will undergo a 12-week low-energy high-protein diet intervention (personalized nutritional counseling by a dietitian).",[13],"Behavioral: Low-Energy High-Protein Diet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Low-Energy High-Protein Diet","This intervention consists of a 12-week low-energy high-protein diet program delivered through structured behavioral and nutritional counseling. Nutrition care process: individual nutritional counseling, one-on-one counseling session conducted by a registered dietitian. The dietary regimen is prescribed with an energy deficit of 500-750 kcal\u002Fday, ensuring a minimum daily energy intake of 1.200 kcal\u002Fday for women and 1.500 kcal\u002Fday for men. Macronutrient distribution is targeted at 1.2-1.6 g\u002Fkg adjusted body weight for protein, 20-30% of total energy for fat, and 45-55% of total energy for carbohydrates.\n\nGenetic profiling using the Gens-HiPro score is conducted to evaluate its role as a modifier of outcome responses in weight loss, body composition, and biochemical parameters.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Yovita Puri Subardjo, S.Gz., Dietisien, MPH","CONTACT","+628174100488","yovitapurisubardjo@mail.ugm.ac.id",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Integrated Health Science Building, Faculty of Health Sciences","Banyumas","Central Java","53122","Indonesia","ID",{"type":36,"coordinates":37},"Point",[38,39],109.29417,-7.51417,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Adendita Azmi Afiattami, S.Gz","+6285117481147","adendita.azmi@unsoed.ac.id",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Yovita Puri Subardjo","PhD student and as a Dietisien",[51,53],{"name":52,"class":6},"Universitas Jenderal Soedirman",{"name":54,"class":55},"Faculty of Medicine, Gadjah Mada University","UNKNOWN","100651325","development-of-a-genetic-score-as-a-response-modifier-for-changes-in-weight-body-composition-and-biochemical-parameters-in-obese-adults-undergoing-a-low-energy-high-protein-diet-intervention-100651325",false,"NCT07760870","Development of a Genetic Score as a Response Modifier for Changes in Weight, Body Composition, and Biochemical Parameters in Obese Adults Undergoing a Low-Energy High-Protein Diet Intervention","Gens-HiPro","Inclusion Criteria:\n\n* Adult males or females aged 18 - 40 years.\n* Classified as obese with a Body Mass Index (BMI) of 27 - 35 kg\u002Fm² and a waist circumference of ≥90 cm for men and ≥80 cm for women.\n* Willing to adhere to the prescribed low-energy high-protein diet.\n* Willing to undergo anthropometric measurements, body composition analysis, lipid profile testing, and genetic variation screening.\n* Signed the written informed consent form.\n\nExclusion Criteria:\n\n* Having chronic diseases that affect metabolism or body weight.\n* Diagnosed with chronic kidney disease (CKD).\n* Currently pregnant, lactating, or planning a pregnancy during the study period.\n* Currently participating in an intensive weight loss program or receiving pharmacological therapy for weight loss within the last 3 months.","ALL","18 Years","40 Years",{"count":67,"type":68},29,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to evaluate whether a genetic score (Gens-HiPro) acts as a response modifier for weight loss, body composition changes, and biochemical parameters in obese adults undergoing a low-energy high-protein diet intervention.\n\nThe main questions it aims to answer is:\n\nDoes the genetic score (Gens-HiPro) modify responses to changes in weight, body composition, and biochemical parameters following a 12-week low-energy high-protein diet?\n\nParticipants will:\n\n* Undergo initial screening to determine eligibility based on inclusion and exclusion criteria\n* Complete baseline data measurement, including demographic data, anthropometric measurements (weight, BMI, body composition), biochemical blood analysis (total cholesterol, triglycerides, HDL, LDL, CRP), dietary assessment.\n* Attend a small-group educational session on general guidelines, portion control, plate model (\"Isi Piringku\"), and food weighing techniques for a low-energy high-protein diet.\n* Receive a 60-90 minute nutritional counseling session led by a dietitian at the start of intervention\n* Follow the prescribed 12-week low-energy high-protein diet, supported by an active messaging channel on weekdays for daily dietary consultations\n* Participate in at least three in-person monitoring and evaluation visits scheduled every 3-4 weeks (at weeks 4, 8, and 12 or weeks 4, 7, 10 and 12)\n* Complete post-intervention evaluations at the end of week 12, repeating all baseline anthropometric, biochemical, and dietary assessments.",[74],"Obesity",[76,77,78,79,80,81],"obesity","nutrigenetics","genetic variation","low-energy high-protein diet","genetic score","gens-hipro","NOT_YET_RECRUITING","2026-08-11",{"date":85,"type":86},"2026-08-13","ACTUAL",{"date":88,"type":68},"2026-09-01",{"date":90,"type":68},"2027-01-31",{"name":5,"class":6},1]