NCT07102667

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

The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenia
• Chronic Kidney Disease

Interventions

Type	Name	Description
BEHAVIORAL	Protein intake 1.2 g/kg/day and resistance exercise	Protein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands
BEHAVIORAL	Protein intake 1.0 g/kg/day and resistance exercise	Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-08-05
• Last updated: 2025-08-11

Locations

1 site across 1 country: Thailand