NCT07102667Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 1 Jun 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Chulalongkorn University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07102667
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jun 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Limitations of body measurements and interpretation using Bioelectrical Impedance Analysis (BIA) e.g. presence of pacemaker, surgical metal implants
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.