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NCT Number: NCT07060040

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

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.

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Key information

Conditions

ESRD (End-Stage Renal Disease) Chronic Disease Deficiency Diseases Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protein Deficiency Protein-Energy Malnutrition Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change in Malnutrition Inflammation Score (MIS)

    Time frame: 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)

  2. Change in Geriatric Nutritional Risk Index (GNRI)

    Time frame: 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)

  3. Change in serum albumin concentration

    Time frame: From enrollment to end of treatment (12 weeks)

    Change in serum albumin level (g/dL)

  4. Change in serum pre-albumin concentration

    Time frame: From enrollment to end of treatment (12 weeks)

    Change in serum pre-albumin level (mg/dL)

  5. Change in Protein-Energy Wasting (PEW) status

    Time frame: From enrollment to end of treatment (12 weeks)

    Change in PEW status based on ISRNM criteria (present/absent)

  6. Change in body composition

    Time frame: From enrollment to end of treatment (12 weeks)

    Change in body composition including lean mass (kg) and fat mass (kg) as measured by bioimpedance

Secondary outcomes

  1. Serum BCAA concentration

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in serum BCAA concentration

  2. Serum indoxyl sulfate concentration

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in serum indoxyl sulfate level

  3. Serum p-cresyl sulfate concentration

    Time frame: From enrollment to end of treatment (12 weeks)

    Change in serum p-cresyl sulfate level

  4. Brief Fatigue Inventory - Taiwanese version

    Time frame: From enrollment to the end of treatment at 12 weeks

    Brief Fatigue Inventory - Taiwanese version (range 0-10; higher scores indicate greater fatigue)

  5. Stool Form Assessment

    Time frame: From enrollment to the end of treatment at 12 weeks

    Bristol Stool Form Scale (a 7-point scale used to classify stool types, with higher score indicates looser stool consistency or more severe diarrhea)

  6. Change in handgrip strength

    Time frame: From enrollment to end of treatment (12 weeks)

    Maximal and average handgrip strength (kg) will be measured using a hand dynamometer.

Other outcomes

  1. Change in gut microbiota composition

    Time frame: From enrollment to the end of treatment at 12 weeks

    Gut microbiota composition (stool), Alpha and Beta diversity indices

Sponsors and collaborators

Lead sponsor

Buddhist Tzu Chi General Hospital

Other

Collaborators

  • Multipower Enterprise Corp.

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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