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

NCT07060040 | Not Yet Recruiting

• 1 other identifier: IRB114-018-A
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

ESRD (End-Stage Renal Disease); Dialysis

Keywords

Branched-chain amino acid; Protein-energy malnutrition; fiber; omega-3; oral nutritional supplements; dialysis

Outcome Measures

Primary Outcomes (6)

• Change in Malnutrition Inflammation Score (MIS)

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

  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)

  From enrollment to the end of treatment at 12 weeks

• Change in serum albumin concentration

  Change in serum albumin level (g/dL)

  From enrollment to end of treatment (12 weeks)

• Change in serum pre-albumin concentration

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

  From enrollment to end of treatment (12 weeks)

• Change in Protein-Energy Wasting (PEW) status

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

  From enrollment to end of treatment (12 weeks)

• Change in body composition

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

  From enrollment to end of treatment (12 weeks)

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Change in gut microbiota composition

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental formula

EXPERIMENTAL

BOSCOGEN 18% Protein ONS (240ml)

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 formula

ACTIVE COMPARATOR

Fresubin dialysis ONS (200 ml)

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

Interventions

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

Experimental formula

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

comparative formula

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead
• Multipower Enterprise Corp.: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Protein-Energy Malnutrition

Interventions

Proteins; Fatty Acids, Omega-3; Dietary Fiber

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Chronic Kidney Disease Prevention and Care

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 11, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share