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AzTrials

ESRD (End-Stage Renal Disease)NCT07060040

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

A study testing BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g and Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g in people with ESRD (End-Stage Renal Disease) and Dialysis, run by Buddhist Tzu Chi General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
ESRD (End-Stage Renal Disease), Dialysis
What is being tested?
BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g and Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Jul 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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.

Being tested
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
Keywords
Branched-chain amino acid, Protein-energy malnutrition, fiber, omega-3, oral nutritional supplements, dialysis
Medical subject headings
Renal Insufficiency, Chronic, Protein-Energy Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 gDietary 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 gDietary supplement

    Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g

Study groups in NCT07060040
Study groupRoleWhat they receive
Experimental formulaExperimentalBOSCOGEN 18% Protein ONS (240ml)
Receives: 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
comparative formulaActive comparatorFresubin dialysis ONS (200 ml)
Receives: Dietary Supplement: Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Malnutrition Inflammation Score (MIS)

    Change in total score of MIS (range 0-30; higher scores indicate worse nutritional status)

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Change in Geriatric Nutritional Risk Index (GNRI)

    Change in GNRI score calculated using serum albumin and body weight (higher scores indicate better nutritional status)

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Change in serum albumin concentration

    Change in serum albumin level (g/dL)

    Measured: From enrollment to end of treatment (12 weeks)

  4. Change in serum pre-albumin concentration

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

    Measured: From enrollment to end of treatment (12 weeks)

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

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

    Measured: From enrollment to end of treatment (12 weeks)

  6. Change in body composition

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

    Measured: From enrollment to end of treatment (12 weeks)

Secondary outcomes (6)

  1. Serum BCAA concentration

    Change in serum BCAA concentration

    Measured: From enrollment to the end of treatment at 12 weeks

  2. Serum indoxyl sulfate concentration

    Change in serum indoxyl sulfate level

    Measured: From enrollment to the end of treatment at 12 weeks

  3. Serum p-cresyl sulfate concentration

    Change in serum p-cresyl sulfate level

    Measured: From enrollment to end of treatment (12 weeks)

  4. Brief Fatigue Inventory - Taiwanese version

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

    Measured: From enrollment to the end of treatment at 12 weeks

  5. 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)

    Measured: From enrollment to the end of treatment at 12 weeks

  6. Change in handgrip strength

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

    Measured: From enrollment to end of treatment (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060040
Sponsor's protocol ID
IRB114-018-A
Status last verified
Jul 2025
First submitted
20 Jun 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BOSCOGEN 18% Protein ONS: Energy 480 kcal, Protein 21.6 g, BCAA 6000 mg, Omega-3 fatty acid 1.8 g, fiber 5 g and Fresubin dialysis ONS (200 ml): Energy 300 kcal, Protein 20 g, BCAA - mg, Omega-3 fatty acid - g, fiber 0.2 g in people with ESRD (End-Stage Renal Disease) and Dialysis, run by Buddhist Tzu Chi General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Malnutrition Inflammation Score (MIS) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.

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