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

NCT ID: NCT07102667

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protein intake of 1.2 g/kg/day

Group Type EXPERIMENTAL

Protein intake 1.2 g/kg/day and resistance exercise

Intervention Type BEHAVIORAL

Protein intake of 1.2 g/kg/day in combination with resistance exercise using resistance bands

Protein intake of 1.0 g/kg/day

Group Type ACTIVE_COMPARATOR

Protein intake 1.0 g/kg/day and resistance exercise

Intervention Type BEHAVIORAL

Protein intake 1.0 g/kg/day in combination with resistance exercise using resistance bands

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Chawalya Angsuwatjarakorn, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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0182/68

Identifier Type: -

Identifier Source: org_study_id

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