Tokyo, March 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060803) titled 'Effects of nutritional supplement drink intake on biochemical indicators in dialysis patients' on March 4.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Medical Corporation Credo Sato Clinic

Condition: Condition - Chronic kidney disease (Hemodialysis patients) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Hemodialysis therapy, due to its therapeutic characteristics, has been noted to potentially remove not only accumulated uremic toxins and excess fluid from the body, but also trace nutrients and vitamins essential for maintaining biological homeostasis. Deficiencies in these nutrients are implicated in impairing the maintenance of normal biological functions and have been suggested to be associated with worsened prognosis. This study therefore investigates the actual state of nutrient loss associated with dialysis treatment, the effects of supplementation, and its safety by administering a nutritional supplement beverage containing protein, vitamins, and tracing elements to hemodialysis patients and examining changes in biochemical indicators. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of nutritional supplement drink.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients undergoing maintenance hemodialysis with a nutritional status of moderate or better. 2) Patients with no problems in eating or swallowing function who can independently consume the test food. 3) Patients who understand the explanation given by the person in charge regarding participation in this study and are able to obtain consent to participate in this study of their own volition. Key exclusion criteria - 1) Patients for whom obtaining their own expression of intent and consent regarding participation in this study are difficult. 2) Patients with blood test results showing serum albumin levels below 3.0 g/dL. 3) Patients for whom discontinuing consumption of foods that could potentially affect fluctuations in protein and micronutrients due to ingestion of the test food is difficult. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 16 Day Anticipated trial start date - 2026 Year 03 Month 06 Day Last follow-up date - 2026 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069563

Disclaimer: Curated by HT Syndication.