Hypoalbuminemia and muscle wasting are important predictors of mortality and morbidity in patients with latter stage chronic kidney disease (CKD). The persistent loss of muscle results from alterations in basal muscle protein metabolism or changes precipitated by hemodialysis (HD). A reduced synthesis of muscle proteins was noted in patients with CKD. We have repeatedly demonstrated the anabolic capacity of a formulation of essential amino acids (EAA) and have developed a supplement designed to maintain muscle mass and function in the elderly. BeneVia(R) is protected under intellectual property and has several advantages over existing products, namely, it is juice based, provides essential ingredients in a small volume (less than 7 oz), is low calorie, and is conveniently packaged. However, further refinement of this product is necessary to address the specific needs of CKD patients. BeneVia(R) Renal will be marketed as a nutritional supplement designed to maintain muscle mass and function and to minimize the catabolic effects of repeated bouts of HD. Accordingly; ingredients are targeted to ameliorate cytokine production and blood acidity. In this Phase 1 application, the general goal will be to determine if the BeneVia(R) Renal formulation stimulates muscle protein synthesis in advanced stage CKD patients to a greater extent than a commonly used formula. We hypothesize that a single dose (6oz or 177ml) of BeneVia(R) Renal will significantly stimulate muscle protein synthesis in CKD patients. Further, we hypothesize that a single dose of BeneVia(R) Renal will stimulate muscle protein synthesis to a greater extent than a single dose (8oz or 237ml) of a popular nutritional therapy designed for dialysis patients (Nepro(R)). Two groups of 12 patients will be randomly assigned to receive either BeneVia(R) Renal or Nepro(R) for 2 weeks prior to a metabolic study utilizing stable isotope methodology to determine muscle protein synthesis. A nutritional formula designed to restore optimal protein metabolism will offset the metabolic alterations that occur during the latter stages of CKD and ameliorate the loss of muscle protein and functional decline.
Public Health Relevance: This proposal describes a nutritional supplement designed to ameliorate the catabolism of advanced CKD. If successful, the result is an economical nutritional product that can be utilized to prevent declines in function and morbidity with renal disease. This will not only improve quality of life in CKD patients, but have a significant impact on overall health care costs.
Public Health Relevance Statement: 7. Project Narrative This proposal describes a nutritional supplement designed to ameliorate the catabolism of advanced CKD. If successful, the result is an economical nutritional product that can be utilized to prevent declines in function and morbidity with renal disease. This will not only improve quality of life in CKD patients, but have a significant impact on overall health care costs.
NIH Spending Category: Assistive Technology; Bioengineering; Clinical Research; Kidney Disease; Nutrition; Prevention
Project Terms: Abnormal Assessment of Metabolism; Acidity; Address; Aeroseb-HC; Aged 65 and Over; Albumins; Amino Acids; Amino Acids, Essential; Anabolism; Blood; CAPS; Capsules; Caseins; Catabolism; Categories; Cell Communication and Signaling; Cell Signaling; Cetacort; Chronic Kidney Failure; Chronic Renal Disease; Clinical Trials, Phase II; Cort-Dome; Cortef; Cortenema; Cortisol; Cortispray; Cortril; Dermacort; Dialysis patients; Diet Supplement; Dietary Proteins; Dietary Supplements; Dose; Drug Formulations; ESRD; Effectiveness; Eldecort; Elderly; Elderly, over 65; End stage renal failure; End-Stage Kidney Disease; Essential Amino Acids; Formulation; Formulations, Drug; Gene Activation; Goals; Gustation; Health Care Costs; Health Costs; Healthcare Costs; Hemodialyses; Hemodialysis; Hydrocortisone; Hydrocortone; Hypoalbuminemia; Hytone; Infusion; Infusion procedures; Insulin Resistance; Intake; Intellectual Property; Intracellular Communication and Signaling; Juice; Kidney; Kidney Diseases; Kidney Failure, Chronic; Laboratories; Life; Light; Marketing; Medical; Metabolic; Metabolic Studies; Metabolism Studies; Method LOINC Axis 6; Methodology; Milk; Morbidity; Morbidity - disease rate; Mortality; Mortality Vital Statistics; Muscle; Muscle Proteins; Muscle Tissue; Muscle, Skeletal; Muscle, Voluntary; Names; Nephropathy; Nutracort; Nutrition; Nutritional; Nutritional Science; Nutritional Supplement; Nutritional Support; Outcome Study; Patients; Peptide Biosynthesis, Ribosomal; Phase; Phase 2 Clinical Trials; Phase II Clinical Trials; Photoradiation; Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-; Proctocort; Production; Protein Biosynthesis; Protein Biosynthesis, Ribosomal; Protein Degradation, Metabolic; Protein Degradation, Regulatory; Protein Synthesis, Ribosomal; Protein Turnover; Proteins; QOL; Quality of life; Randomized; Renal Disease; Renal Disease, End-Stage; Renal Failure, Chronic; Research Support; Reticuloendothelial System, Blood; Role; Sales; Science of nutrition; Signal Transduction; Signal Transduction Systems; Signaling; Skeletal Muscle Tissue; Skeletal muscle structure; Solid; Staging; Stimulus; Taste; Taste Perception; Testing; Therapeutic Hydrocortisone; Urinary System, Kidney; advanced age; aminoacid; base; beef; biological adaptation to stress; biological signal transduction; biosynthesis; capsule (pharmacologic); chronic kidney disease; cytokine; decline in function; design; designing; drinking; elders; essential amino acid; essential aminoacid; functional decline; gene product; geriatric; improved; insulin resistant; intervention design; kidney disorder; late life; later life; metabolic abnormality assessment; muscle form; nutrition; nutritional care; nutritional therapy; older adult; older person; phase 2 study; phase 2 trial; phase II trial; prevent; preventing; product development; protein degradation; protein metabolism; protein synthesis; protocol, phase II; public health relevance; randomisation; randomization; randomly assigned; reaction; crisis; renal; renal disorder; senior citizen; social role; stable isotope; stress response; stress; reaction; study, phase II; therapy design; treatment design; wasting
