The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Malnutrition Inflammation Score (MIS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Patients with severe illnesses (including burn injuries), undergoing major surgery, with abnormal liver function (GOT and GPT levels more than 5 times the upper limit of normal), or with malignancy (6) Participation in another clinical trial of investigational drugs or concurrent use of investigational drugs within 30 days prior to or during this trial (7) Any other serious medical condition as determined by the investigator that would make the patient unsuitable for participation
结局指标
主要结局
Change in Malnutrition Inflammation Score (MIS)
时间窗: From enrollment to the end of treatment at 12 weeks
Change in total score of MIS (range 0-30; higher scores indicate worse nutritional status)
Change in Geriatric Nutritional Risk Index (GNRI)
时间窗: From enrollment to the end of treatment at 12 weeks
Change in GNRI score calculated using serum albumin and body weight (higher scores indicate better nutritional status)
Change in serum albumin concentration
时间窗: From enrollment to end of treatment (12 weeks)
Change in serum albumin level (g/dL)
Change in serum pre-albumin concentration
时间窗: From enrollment to end of treatment (12 weeks)
Change in serum pre-albumin level (mg/dL)
Change in Protein-Energy Wasting (PEW) status
时间窗: From enrollment to end of treatment (12 weeks)
Change in PEW status based on ISRNM criteria (present/absent)
Change in body composition
时间窗: From enrollment to end of treatment (12 weeks)
Change in body composition including lean mass (kg) and fat mass (kg) as measured by bioimpedance
次要结局
- Serum BCAA concentration(From enrollment to the end of treatment at 12 weeks)
- Serum indoxyl sulfate concentration(From enrollment to the end of treatment at 12 weeks)
- Serum p-cresyl sulfate concentration(From enrollment to end of treatment (12 weeks))
- Brief Fatigue Inventory - Taiwanese version(From enrollment to the end of treatment at 12 weeks)
- Stool Form Assessment(From enrollment to the end of treatment at 12 weeks)
- Change in handgrip strength(From enrollment to end of treatment (12 weeks))
研究者
Yu-Li Lin
Director, Center for Chronic Kidney Disease Prevention and Care
Buddhist Tzu Chi General Hospital