Tests protein intake and exercise for muscle loss in older adults with kidney disease
Compares two protein amounts with home exercise in older adults with early kidney disease.
Plain-language title generated from the registry record
Registry title: The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease
Key facts
- Where
- Bangkok, ThailandSee the site
Where in Thailand
- King Chulalongkorn Memorial HospitalBangkok, ThailandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chulalongkorn University
- Trial code
- NCT07102667
- Record updated
- 11 August 2025
- Original description
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:Read full original descriptionShow less
The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
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.
Inclusion: Thai adults aged ≥ 65 years; Chronic kidney disease with estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2; Sarcopenia or presarcopenia (diagnosis based on Asian Working Group for Sarcopenia (AWGS) 2019 definition).
Exclusion: Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants; Active cardiopulmonary disease(s) or uncontrolled hypertension with contraindications to resistance training; Physically or cognitively unable to participate in the resistance exercise program (e.g. dementia), as determined by the attending physician; Meets the definition of AKI or AKD, defined as alterations in kidney function within the past 3 months; Severe vitamin D deficiency (25-OH Vitamin D level < 10 ng/mL); Refuses to give consent to participate in the study.