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

Launched by BUDDHIST TZU CHI GENERAL HOSPITAL · Jul 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special nutritional drink designed specifically for people with end-stage kidney disease who are on dialysis and have mild to moderate malnutrition. The drink contains important nutrients like branched-chain amino acids (which help build muscle), omega-3 fatty acids (good for heart and overall health), and dietary fiber (which supports digestion). The goal is to see if this drink can improve patients’ nutrition, reduce tiredness, and help them feel better overall. The study will look at changes in nutrition levels, appetite, fatigue, and other health markers related to kidney disease and digestion.

To take part, patients need to be 20 years or older, have been on dialysis for more than three months, and show signs of mild to moderate malnutrition, such as low protein levels in their blood or low body weight. People with very low protein levels, severe illnesses, or allergies to the drink’s ingredients cannot join. Participants will be asked to consume the nutritional supplement and have their health monitored throughout the study. This trial is not yet recruiting, but it aims to help improve quality of life for dialysis patients struggling with nutrition.

Gender

ALL

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