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

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.

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Key information

Conditions

Sarcopenia Atrophy Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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
Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants
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

Treatment and study plan

Protein intake 1.2 g/kg/day and resistance exercise

Behavioral

Protein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands

Protein intake 1.0 g/kg/day and resistance exercise

Behavioral

Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands

Primary outcomes

Between-Group Differences in Muscle Mass Changes at 6 Months

Time frame: From enrollment to the end of intervention at 24 weeks

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Aug 5, 2025
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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