SarcopeniaNCT07102667
The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease
A study testing Protein intake 1.2 g/kg/day and resistance exercise and Protein intake 1.0 g/kg/day and resistance exercise in people with Sarcopenia and Chronic Kidney Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Chronic Kidney Disease
- What is being tested?
- Protein intake 1.2 g/kg/day and resistance exercise and Protein intake 1.0 g/kg/day and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
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?
Read more
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.
- Conditions
- Sarcopenia, Chronic Kidney Disease
- Being tested
- Protein intake 1.2 g/kg/day and resistance exercise, Protein intake 1.0 g/kg/day and resistance exercise
- Keywords
- Sarcopenia, Chronic kidney disease, Protein intake, Nutrition
- Medical subject headings
- Sarcopenia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein intake 1.2 g/kg/day and resistance exerciseBehavioural
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 exerciseBehavioural
Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands
| Study group | Role | What they receive |
|---|---|---|
| Protein intake of 1.2 g/kg/day | Experimental | Not described Receives: Behavioral: Protein intake 1.2 g/kg/day and resistance exercise |
| Protein intake of 1.0 g/kg/day | Active comparator | Not described Receives: Behavioral: Protein intake 1.0 g/kg/day and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-Group Differences in Muscle Mass Changes at 6 Months
Measured: From enrollment to the end of intervention at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chawalya Angsuwatjarakorn, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102667
- Sponsor's protocol ID
- 0182/68
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Protein Intake to Enhance Muscle Mass in Elderly Patients With Pre-dialysis Chronic Kidney Disease: A Randomized Active-Controlled Trial
- ClinicalTrials.gov ID
- NCT07102667
- Acronym / sponsor ID
- 0182/68
- Conditions
- Sarcopenia, Chronic Kidney Disease
- Keywords
- Sarcopenia, Chronic kidney disease, Protein intake, Nutrition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein intake of 1.2 g/kg/day | Experimental | Behavioral: Protein intake 1.2 g/kg/day and resistance exercise |
| Protein intake of 1.0 g/kg/day | Active comparator | Behavioral: Protein intake 1.0 g/kg/day and resistance exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein intake 1.2 g/kg/day and resistance exerciseProtein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands | Behavioural | Protein intake of 1.2 g/kg/day |
| Protein intake 1.0 g/kg/day and resistance exerciseProtein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands | Behavioural | Protein intake of 1.0 g/kg/day |
Primary outcome
Between-Group Differences in Muscle Mass Changes at 6 Months
Time frame: From enrollment to the end of intervention at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein intake 1.2 g/kg/day and resistance exercise and Protein intake 1.0 g/kg/day and resistance exercise in people with Sarcopenia and Chronic Kidney Disease, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-Group Differences in Muscle Mass Changes at 6 Months (time frame: From enrollment to the end of intervention at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.