NCT07102667
Enrolling By Invitation
Not Applicable
The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Chulalongkorn University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Between-Group Differences in Muscle Mass Changes at 6 Months
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Between-Group Differences in Muscle Mass Changes at 6 Months
Time Frame: From enrollment to the end of intervention at 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Chawalya Angsuwatjarakorn, MD
Principal Investigator
Chulalongkorn University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Increase Protein Intake in ElderlyMarkedly Reduced Food IntakeNCT01907152Wageningen University and Research106
Recruiting
Not Applicable
Protein and Exercise for Postmenopausal Women's WellbeingNCT06849817University of Arkansas, Fayetteville90
Completed
Not Applicable
Dietary Interventions for Muscle MassAgingNCT01145131Maastricht University Medical Center12
Completed
Not Applicable
The Importance of Additional Protein to Benefit More From Training During and After HospitalizationSarcopeniaNCT02717819Forskningsenheden165
Not yet recruiting
Early Phase 1
Effectiveness of Protein Supplementation on Frailty Improvement, Muscle Strength and Physical Performance Among Pre-Frail Elderly PeopleFrailtyMuscle WeaknessPhysical DependenceWeight LossNCT05648617Universiti Putra Malaysia40