The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease
NCT ID: NCT07102667
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
60 participants
INTERVENTIONAL
2025-06-01
2026-06-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Protein intake of 1.2 g/kg/day
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
Protein intake of 1.0 g/kg/day
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Chawalya Angsuwatjarakorn, MD
Principal Investigator
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Countries
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Other Identifiers
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0182/68
Identifier Type: -
Identifier Source: org_study_id
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