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| Name | Class |
|---|---|
| Multipower Enterprise Corp. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental formula | Experimental | BOSCOGEN 18% Protein ONS (240ml) |
|
| comparative formula | Active Comparator | Fresubin dialysis ONS (200 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g | Dietary Supplement | Oral nutritional supplementation: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Malnutrition Inflammation Score (MIS) | Change in total score of MIS (range 0-30; higher scores indicate worse nutritional status) | 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) | From enrollment to the end of treatment at 12 weeks |
| Change in serum albumin concentration | Change in serum albumin level (g/dL) | From enrollment to end of treatment (12 weeks) |
| Change in serum pre-albumin concentration | Change in serum pre-albumin level (mg/dL) | 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) | 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 | From enrollment to end of treatment (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum BCAA concentration | Change in serum BCAA concentration | From enrollment to the end of treatment at 12 weeks |
| Serum indoxyl sulfate concentration | Change in serum indoxyl sulfate level |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gut microbiota composition | Gut microbiota composition (stool), Alpha and Beta diversity indices | From enrollment to the end of treatment at 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g | Dietary Supplement | Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g |
|
| From enrollment to the end of treatment at 12 weeks |
| Serum p-cresyl sulfate concentration | Change in serum p-cresyl sulfate level | 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) | 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) | 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. | From enrollment to end of treatment (12 weeks) |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011502 | Protein-Energy Malnutrition |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011488 | Protein Deficiency |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| D015525 | Fatty Acids, Omega-3 |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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