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

Chulalongkorn University

Status

Invitation-only

Conditions

Chronic Kidney Disease

Sarcopenia

Treatments

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07102667

0182/68

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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