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

ConditionsESRD (End-Stage Renal Disease)Dialysis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorBuddhist Tzu Chi General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Experimental formulaExperimental treatment 1 intervention

Group B: comparative formulaActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Malnutrition Inflammation Score (MIS)

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

Time frame

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)

Time frame

From enrollment to the end of treatment at 12 weeks

Change in serum albumin concentration

Change in serum albumin level (g/dL)

Time frame

From enrollment to end of treatment (12 weeks)

Change in serum pre-albumin concentration

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

Time frame

From enrollment to end of treatment (12 weeks)

Secondary outcomes

Serum BCAA concentration

Change in serum BCAA concentration

Time frame

From enrollment to the end of treatment at 12 weeks

Serum indoxyl sulfate concentration

Change in serum indoxyl sulfate level

Time frame

From enrollment to the end of treatment at 12 weeks

Serum p-cresyl sulfate concentration

Change in serum p-cresyl sulfate level

Time frame

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)

Time frame

From enrollment to the end of treatment at 12 weeks

Other outcomes

Change in gut microbiota composition

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

Time frame

From enrollment to the end of treatment at 12 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Buddhist Tzu Chi General Hospital

Lead sponsor

Multipower Enterprise Corp.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: