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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07102667
Enrollment
60
Registered
2025-08-05
Start date
2025-06-01
Completion date
2026-06-30
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Sarcopenia

Keywords

Sarcopenia, Chronic kidney disease, Protein intake, Nutrition

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.

Interventions

BEHAVIORALProtein 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

BEHAVIORALProtein intake 1.0 g/kg/day and resistance exercise

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

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Between-Group Differences in Muscle Mass Changes at 6 MonthsFrom enrollment to the end of intervention at 24 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026