The aim of this study is to evaluate the effects of a specialized oral nutritional supplement (SF) enriched with BCAAs, omega-3 fatty acids, and dietary fiber on improving the nutritional status of dialysis patients with mild to moderate malnutrition, and thereby alleviating fatigue and enhancing quality of life. We will assess various aspects of protein-energy wasting (PEW), as well as changes in the Malnutrition Inflammation Score (MIS), Geriatric Nutritional Risk Index (GNRI), fatigue, appetite, serum BCAA levels, uremic toxins, and gut microbiota composition.
Protein-energy wasting (PEW) is highly prevalent in dialysis patients. If not promptly addressed, PEW increases the risk of falls, disability, fractures, hospitalization, and mortality, while significantly impairing quality of life. In clinical care, nutritional supplementation can prevent the onset of PEW and improve quality of life by reducing the severity of malnutrition. Numerous studies and meta-analyses have shown that dietary fiber can help reduce uremic toxins in CKD and dialysis patients. Additionally, research has shown that the loss of branched-chain amino acids (BCAAs) during dialysis can lead to poor appetite, fatigue, and increased risk of PEW. In elderly hemodialysis patients, supplementation with 12 g/day of BCAAs has been shown to reduce anorexia and significantly improve nutritional status. The aim of this study is to improve the nutritional status of dialysis patients with mild to moderate malnutrition by providing a specialized formula (SF) supplement enriched with branched-chain amino acids (BCAAs), omega-3 fatty acids, and dietary fiber. The ultimate goal is to alleviate fatigue and enhance quality of life. We will simultaneously evaluate changes in multiple aspects of protein-energy wasting (PEW), the malnutrition inflammation score (MIS), the Geriatric Nutritional Risk Index (GNRI), fatigue levels, appetite, serum BCAA concentrations, uremic toxins, and gut microbiota composition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Oral nutritional supplementation: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g
Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g
Change in Malnutrition Inflammation Score (MIS)
Change in total score of MIS (range 0-30; higher scores indicate worse nutritional status)
Time frame: From enrollment to the end of treatment at 12 weeks
Change in Geriatric Nutritional Risk Index (GNRI)
Change in GNRI score calculated using serum albumin and body weight (higher scores indicate better nutritional status)
Time frame: From enrollment to the end of treatment at 12 weeks
Change in serum albumin concentration
Change in serum albumin level (g/dL)
Time frame: From enrollment to end of treatment (12 weeks)
Change in serum pre-albumin concentration
Change in serum pre-albumin level (mg/dL)
Time frame: From enrollment to end of treatment (12 weeks)
Change in Protein-Energy Wasting (PEW) status
Change in PEW status based on ISRNM criteria (present/absent)
Time frame: From enrollment to end of treatment (12 weeks)
Change in body composition
Change in body composition including lean mass (kg) and fat mass (kg) as measured by bioimpedance
Time frame: From enrollment to end of treatment (12 weeks)
Serum BCAA concentration
Change in serum BCAA concentration
Time frame: From enrollment to the end of treatment at 12 weeks
Serum indoxyl sulfate concentration
Change in serum indoxyl sulfate level
Time frame: From enrollment to the end of treatment at 12 weeks
Serum p-cresyl sulfate concentration
Change in serum p-cresyl sulfate level
Time frame: From enrollment to end of treatment (12 weeks)
Brief Fatigue Inventory - Taiwanese version
Brief Fatigue Inventory - Taiwanese version (range 0-10; higher scores indicate greater fatigue)
Time frame: From enrollment to the end of treatment at 12 weeks
Stool Form Assessment
Bristol Stool Form Scale (a 7-point scale used to classify stool types, with higher score indicates looser stool consistency or more severe diarrhea)
Time frame: From enrollment to the end of treatment at 12 weeks
Change in handgrip strength
Maximal and average handgrip strength (kg) will be measured using a hand dynamometer.
Time frame: From enrollment to end of treatment (12 weeks)
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