Sarcopenia in Chronic Kidney Disease (CKD) Patients (BOOST_CKD)

February 25, 2026 updated by: Subrata Debnath, The University of Texas Health Science Center at San Antonio

Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)

Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease.

The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall objective of this study is to evaluate the feasibility, tolerability, metabolic effects, and potential therapeutic potential of isolated valine or EAA in patients with CKD stage 5.

  • Primary Objective: To evaluate the feasibility, tolerability, and potential therapeutic benefits of isolated valine or EAA for the management of sarcopenia in patients with stage 5 CKD not on dialysis.
  • Secondary Objectives: To assess the effects of valine and EAA on measures of kidney function and anorexia in patients with stage 5 CKD not on dialysis.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ability of participant to understand and the willingness to sign a written informed consent document.
  2. Males and females of age 45-75 yrs
  3. Hand grip strength of <26 kg for male and <16 kg for female
  4. Documented diagnosis of estimated glomerular filtration rate (eGFR) of ≤15 mL/min/1.73 m2, based on CKD-EPI serum-creatinine based formula in the past ≥3 months in absence of acute kidney injury.
  5. Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months
  6. Receiving standard of care including dietary recommendation for diabetes, hypertension, CKD, and other comorbidities
  7. Patients who are on an SGLT2-i or GLP-1 agonist should be on a stable dose for at least 3 months prior randomization, with no dose adjustments expected in the next 4 months
  8. Serum HCO3 concentration 20-29 mmol/L based on two consecutive recent routine labs
  9. HbA1c 7-9% based on most recent routine lab
  10. Serum albumin ≥3.8 g/dL based on most recent routine lab
  11. Blood hemoglobin ≥10 g/dL based on most recent routine lab
  12. Willingness to adhere to lifestyle management, including diet and exercise as recommended by care providers, and to the study intervention, procedures, and regimen.

Exclusion Criteria:

  1. Any known history of hypersensitivity/intolerance to valine or specific amino acids
  2. Any condition that may indicate the individual is not "metabolically stable" which may include active infection, currently on systemic antibiotic, hospitalization within 2 weeks on consenting, active malignancy, on immunosuppressive agents, and unexplained significant weight loss during the past 3 months
  3. With a cardiac pacemaker and/or an implantable cardioverter-defibrillator
  4. Significant arthritis prohibiting strength test and walk gait speed test
  5. Significant comorbidities including heart failure (NY Class III or IV), neurological disorders, HIV AIDS, etiology of CKD other than diabetes and hypertension, or any condition that could compromise the subject's ability to study procedures as judged by study clinician
  6. Currently taking any protein supplements
  7. Pregnant, lactating, childbearing women
  8. History of Maple syrup urine disease (MSUD)
  9. Scheduled for kidney transplantation or dialysis in next 4 months
  10. Current participation in another interventional trial
  11. Documented noncompliance with regard to clinic visits, medications, and lifestyle management.
  12. Documentation of current or history of substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group Valine
Daily oral consumption of 2 g valine, divided into two meals (1 g per meal, one packet), each equivalent to approximately 0.8 g of protein.
Drug: Valine
A medical food intended for use under medical supervision
Other Names:
  • Valine Amino Acid Supplement
Experimental: Treatment group EEA
Daily oral consumption of 20 g essential amino acids (EAA), divided into two meals (10 g per meal, one packet), each equivalent to 5 g of protein and 3.14 g of branched chain amino acids (BCAA).
Drug: EEA
A medical food intended for use under medical supervision
Other Names:
  • Essential Amino Acid Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle strength (handgrip strength test)
Time Frame: Baseline to 14 weeks
Change from baseline handgrip strength test value (kg) measured using a hand dynamometer to the end of each 6-Week intervention
Baseline to 14 weeks
Muscle mass
Time Frame: Baseline to 14 weeks
Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention
Baseline to 14 weeks
Physical performance (4-meter Walk Gait Speed Test or 4MWT)
Time Frame: Baseline to 14 weeks
Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention
Baseline to 14 weeks
Incidence of patient-reported symptoms
Time Frame: Baseline to 14 weeks
Change from baseline (number of symptoms) to the end of each 6-Week intervention
Baseline to 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale
Time Frame: Baseline to 14 weeks
Change from baseline scores (ranging from 0-48, with 0 being the worst possible score) to the end of each 6-Week intervention
Baseline to 14 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Cystatin C-based eGFR
Time Frame: Baseline to 14 weeks
Change from baseline serum Cystatin C levels (mg/L) to the end of each 6-Week intervention
Baseline to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Subrata Debnath, PhD, University of Texas Health Science Center San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002368
  • P30AG044271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.

IPD Sharing Time Frame

Data may be available beginning 1 year after the end of the trial and publication of the primary outcomes, and will be available for 24 months.

IPD Sharing Access Criteria

Data may be available to researchers who provide a methodologically sound proposals. Proposals should be directed to the principal investigator. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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