[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649114":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":50,"locations":56,"responsibleParty":72,"collaborators":31,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":31,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":31,"enrollmentInfo":83,"targetDuration":31,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":99,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Normocaloric Normal-Protein Diet (NCNP)","ACTIVE_COMPARATOR","Participants will receive an individualized normocaloric normoprotein diet providing 1.0 g protein\u002Fkg\u002Fday, 55% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal\u002Fkg\u002Fday) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet.",[13,14],"Dietary Supplement: Placebo","Behavioral: Individualized Dietary Counseling",{"label":16,"type":17,"description":18,"interventionNames":19},"Normocaloric High-Protein Diet (NCHP)","EXPERIMENTAL","Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein\u002Fkg\u002Fday, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal\u002Fkg\u002Fday) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily placebo sachet.",[13,14],{"label":21,"type":17,"description":22,"interventionNames":23},"Normocaloric High-Protein Diet + HMB (NCHP+HMB)","Participants will receive an individualized normocaloric high-protein diet providing 1.5 g protein\u002Fkg\u002Fday, 50% of total energy from carbohydrates, and 30% from lipids for 8 weeks. Energy intake (20-30 kcal\u002Fkg\u002Fday) will be individualized to maintain body weight. Dietary counseling will be based on the DASH dietary pattern and the Brazilian Dietary Guidelines. Participants will also receive one daily HMB-enriched nutritional supplement providing 3 g\u002Fday of β-hydroxy-β-methylbutyrate (HMB).",[24,14],"Dietary Supplement: β-Hydroxy-β-Methylbutyrate (HMB)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","β-Hydroxy-β-Methylbutyrate (HMB)","Participants will receive one daily sachet of a powdered nutritional supplement enriched with 3 g of β-hydroxy-β-methylbutyrate (HMB) for 8 weeks. The supplement will be dissolved in water and consumed once daily.",[21],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","Participants will receive one daily placebo sachet identical in appearance, flavor, and packaging to the HMB supplement for 8 weeks",[16,9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"BEHAVIORAL","Individualized Dietary Counseling","Participants will receive individualized dietary counseling from a registered dietitian. Energy intake will be prescribed at 20-30 kcal\u002Fkg\u002Fday to maintain body weight. According to randomization, participants will receive either a normoprotein diet (1.0 g protein\u002Fkg\u002Fday) or a high-protein diet (1.5 g protein\u002Fkg\u002Fday), based on the DASH dietary pattern and the Brazilian Dietary Guidelines.",[16,21,9],[42,46],{"name":43,"affiliation":44,"role":45},"Gabriela C Souza, RD, PhD","Hospital de Clínicas de Porto Alegre (HCPA)","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":49},"Flávia M Silva, RD, PhD","Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA)","STUDY_CHAIR",[51],{"name":52,"role":53,"phone":54,"phoneExt":31,"email":55},"Ingrid S Knobloch, PhD Candidate","CONTACT","+55 51 3359 6275","iknobloch@hcpa.edu.br",[57],{"facility":58,"status":31,"city":59,"state":60,"zip":31,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Hospital de Clínicas de Porto Alegre (Clinical Research Center)","Porto Alegre","Rio Grande do Sul","Brazil","BR",{"type":64,"coordinates":65},"Point",[66,67],-51.23019,-30.03283,{"lat":67,"lon":66},[70],{"name":71,"role":53,"phone":54,"phoneExt":31,"email":55},"Ingrid S Knobloch, PhD Canditate",{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100649114","high-protein-diet-and-hmb-supplementation-in-patients-with-heart-failure-100649114",false,"NCT07731048","High-Protein Diet and HMB Supplementation in Patients With Heart Failure","Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Male or female;\n* Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records.\n\nExclusion Criteria:\n\n* Chronic kidney disease stage 3b or higher;\n* Listed for heart transplantation;\n* Hospitalization for decompensated heart failure within the previous 3 months;\n* Active cancer treatment or cancer treatment within the previous 5 years;\n* History of alcohol or illicit drug abuse within the previous 12 months;\n* Chronic use of anti-inflammatory drugs, anticonvulsants, corticosteroids, or immunosuppressive agents;\n* Pregnancy or breastfeeding;\n* Wheelchair use preventing anthropometric assessment;\n* Current use of protein supplements;\n* Participation in another randomized clinical trial with interventions that may interfere with the primary outcome.","ALL","18 Years",{"count":84,"type":85},84,"ESTIMATED","INTERVENTIONAL",[88],"NA","The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are:\n\n1. Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks?\n2. Does adding 3 g\u002Fday of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone?\n3. Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks?\n\nResearchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes.\n\nParticipants will:\n\n* Be randomly assigned to one of the three study groups\n* Receive individualized dietary counseling according to their assigned intervention\n* Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g\u002Fday of HMB) or a matched placebo, according to the assigned study group\n* Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks",[91],"Heart Failure",[93,94,95,96,97,98],"High-Protein Diet","β-Hydroxy-β-Methylbutyrate","Muscle Mass","Muscle Strength","Physical Function","Dietary Intervention","NOT_YET_RECRUITING","2026-07-23",{"date":102,"type":103},"2026-07-28","ACTUAL",{"date":105,"type":85},"2026-09-01",{"date":107,"type":85},"2027-11-30",{"name":5,"class":6},1]