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Not yet recruiting NCT07060040

The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status

No phase Interventional ESRD (End-Stage Renal Disease) Dialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: ESRD (End-Stage Renal Disease), Dialysis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Dietary supplement BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g
    Oral nutritional supplementation: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 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
    Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g

Primary outcome measures

  • Change in Malnutrition Inflammation Score (MIS) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Change in Geriatric Nutritional Risk Index (GNRI) [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Change in serum albumin concentration [Time frame: From enrollment to end of treatment (12 weeks)]
  • Change in serum pre-albumin concentration [Time frame: From enrollment to end of treatment (12 weeks)]
  • Change in Protein-Energy Wasting (PEW) status [Time frame: From enrollment to end of treatment (12 weeks)]
  • Change in body composition [Time frame: From enrollment to end of treatment (12 weeks)]
Secondary outcome measures (6)
  • Serum BCAA concentration [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Serum indoxyl sulfate concentration [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Serum p-cresyl sulfate concentration [Time frame: From enrollment to end of treatment (12 weeks)]
  • Brief Fatigue Inventory - Taiwanese version [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Stool Form Assessment [Time frame: From enrollment to the end of treatment at 12 weeks]
  • Change in handgrip strength [Time frame: From enrollment to end of treatment (12 weeks)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07060040 · IRB114-018-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗