About this trial
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.
Eligibility criteria
Qualifiers
Patients with ESRD who have been receiving dialysis for more than three months
Serum albumin (Alb) ≤ 4.0 g/dL, or body mass index (BMI) ≤ 20, or normalized protein catabolic rate (nPCR) ≤ 0.8
Male or female patients aged 20 years or older
Disqualifiers
Serum albumin (Alb) < 3.0 g/dL
Known allergy or intolerance to any component of the product, or deemed by a physician to be unable to complete the trial
Patients who refuse to sign the informed consent form or are unable to follow study instructions
Pregnant or breastfeeding women
Trial design
Treatments tested in this trial
- BOSCOGEN 18% Protein ONS: 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
Treatment groups
Locations
Sponsors and collaborators
Buddhist Tzu Chi General Hospital
Lead sponsor
Multipower Enterprise Corp.
Collaborator