Clinical Trial

The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease

Enrolling by Invitation
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Record status
This record was last updated August 11, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to determine whether increasing protein intake in elderly adults with pre-dialysis chronic kidney disease, in combination with resistance exercise, improves muscle mass without worsening renal function.The main questions it aims to answer are: * Does a protein intake of 1.2 g/kg BW/day combined with exercise improve muscle mass better than a protein intake of 1.0 g/kg BW/day? * Does a protein intake of 1.2 g/kg BW/day combined with exercise lead to greater improvements in muscle strength and function? * Does a protein intake of 1.2 1.2 g/kg BW/day combined with exercise cause a decline in renal function (eGFR) compared to a protein intake of 1.0 1.2 g/kg BW/day? Researchers will compare a group assigned to intake 1.2 g/kg BW/day of protein with another group assigned to intake 1.0 g/kg BW/day, to assess whether the higher intake improves muscle mass and physical performance without causing harm. Participants will * be assessed for body composition, physical performance and nutritional intake. * be assigned to consume protein at either 1.2 or 1.0 g/kg/day. * perform a home-based resistance exercise program using resistance bands. * provide blood and urine sample to monitor renal function. * visit the clinic at weeks 12 and 24 for repeated measurement.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-30.
Trial Details
NCT Number NCT07102667
Lead Sponsor Chulalongkorn University
Conditions Sarcopenia, Chronic Kidney Disease
Enrollment 60 participants
Start Date 2025-06-01
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-11