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

NCT07102667 | Enrolling By Invitation DMC

• 1 other identifier: 0182/68
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sarcopenia; Chronic kidney disease; Protein intake; Nutrition

Outcome Measures

Primary Outcomes (1)

• Between-Group Differences in Muscle Mass Changes at 6 Months

  From enrollment to the end of intervention at 24 weeks

Study Arms (2)

Protein intake of 1.2 g/kg/day

EXPERIMENTAL

Behavioral: Protein intake 1.2 g/kg/day and resistance exercise

Protein intake of 1.0 g/kg/day

ACTIVE COMPARATOR

Behavioral: Protein intake 1.0 g/kg/day and resistance exercise

Interventions

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 of 1.2 g/kg/day

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

Protein intake of 1.0 g/kg/day

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Sarcopenia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

TH (1)