The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Protein intake 1.2 g/kg/day and resistance exercise, Protein intake 1.0 g/kg/day and resistance exercise.
- Who it may be relevant to
- Registry conditions: Sarcopenia, Chronic Kidney Disease. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
Overview
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
- Behavioral 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 - Behavioral 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
Primary outcome measures
- Between-Group Differences in Muscle Mass Changes at 6 Months [Time frame: From enrollment to the end of intervention at 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- King Chulalongkorn Memorial Hospital — Bangkok
Identifiers
NCT: NCT07102667 · 0182/68