[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611239":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":58,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":12,"overallStatus":91,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Nottingham","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Protein Arm","NO_INTERVENTION","In the Standard Protein Arm, participants will aim to consume at least 1.0g of protein per kg of dry body weight.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"High Protein Arm","EXPERIMENTAL","In the High Protein arm, participants will need to consume 1.4g of protein per kg of dry body weight a day and protein supplements will be used to achieve this (Renapro and Renapro shot)",[18],"Dietary Supplement: High Protein Diet\u002FModular protein supplements will be used",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIETARY_SUPPLEMENT","High Protein Diet\u002FModular protein supplements will be used","High Protein Diet\u002FSupplements 1.4g\u002Fkg\u002Fbody weight\u002Fday",[14],[26],{"name":27,"affiliation":5,"role":28},"Nicholas Selby, BMedSci BMBS DM","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Bruno Mafrici, MSc, BSc","CONTACT","0044 +115 9691169","77139","bruno.mafrici2@nottingham.ac.uk",{"name":37,"role":32,"phone":12,"phoneExt":12,"email":38},"Matthew Hall, MA, MBBChir, MD, FRCP","matthew.hall10@nhs.net",[40],{"facility":41,"status":12,"city":42,"state":12,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre for Kidney Research and Innovation (CKRI), Academic Unit for Translational Medical Sciences School of Medicine (Royal Derby Hospital Campus)","Nottingham","NG7 2QL","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-1.15047,52.9536,{"lat":50,"lon":49},[53,54],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":55,"role":28,"phone":12,"phoneExt":12,"email":12},"Bruno Mafrici, BSC, MSc",{"type":57,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[59,61],{"name":60,"class":6},"Nottingham University Hospitals NHS Trust",{"name":62,"class":6},"University Hospitals of Derby and Burton NHS Foundation Trust","100611239","protein-supplementation-during-dialysis-prosed-100611239",false,"NCT07237997","Protein Supplementation During Dialysis (PROSED)","Re-examining Nutrition in Dialysis Patients: Nutritional Losses and the Role of Supplementation (Part 2).","PROSED","Inclusion Criteria:\n\n* Age ≥ 18 years (no upper age limit)\n* Patients receiving maintenance dialysis for ≥ three months\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Anticipated live donor kidney transplant and\u002For kidney recovery within the period of sample collection.\n* Anticipated change of dialysis modality within the period of sample collection\n* Severe malnutrition based on either:\n\n  * Renal 7-point Subjective Global Assessment (SGA) scores of 1-2\n  * Global Leadership Initiative Malnutrition (GLIM) Stage 2\n* Protein-losing enteropathy.\n* Persistent nephrotic syndrome with \\>3g\u002Fday urinary protein loss.\n* Active wounds or burns contributing to protein losses as judged by the investigator.\n* Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).\n* Current malignancy based on recent (\\\u003C12 months) diagnosis and\u002For active treatment for malignancy and\u002For planned treatment for malignancy, excluding non-melanoma skin cancers.\n* Pregnancy (current or planned within duration of study) or breast feeding.\n* People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).\n* People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding\n* People prescribed levodopa\n* People who are receiving chronic glucocorticoid therapy (\\>10mg day prednisolone or equivalent for \\>7 days within preceding 90 days).\n* People who are consuming a protein dietary intake above 1.5g protein\u002Fkg\u002Fbody weight.\n* People who, in the opinion of the investigator, will be unable to comply with study protocol requirements.\n* People who are vegan or other religious based dietary restrictions which would prevent them taking the supplement.","ALL","18 Years",{"count":74,"type":75},114,"ESTIMATED","INTERVENTIONAL",[78],"NA","When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein\u002Fday (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.\n\nDialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.",[81,82,83,84,85,86,87,88,89,90],"Dialysis Patients","Dialysis","Protein Energy Wasting","Protein Intake","High Protein Dietary Intake","Diet","Diet Therapy","Hospitalisation","Muscle Mass and Strength","Muscle Mass","NOT_YET_RECRUITING","2025-11-14",{"date":94,"type":95},"2025-11-20","ACTUAL",{"date":97,"type":75},"2026-01-05",{"date":99,"type":75},"2029-10-30",{"name":5,"class":6},1]