Sarcopenia in Chronic Kidney Disease (CKD) Patients
Part of paid clinical trials in San Antonio, Texas.
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Study ID
- NCT07437053
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- Chronic Kidney Disease
- Sarcopenia
Eligibility Criteria
- Sex
- ALL
- Age
- 45 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Valine — DRUGA medical food intended for use under medical supervision
- EEA — DRUGA medical food intended for use under medical supervision
Study Details
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.
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- Feb 2026
- Primary completion
- Jul 31, 2027
- Completion
- Oct 30, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment group ValineDaily 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.
- Experimental: Treatment group EEADaily 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).
Primary Outcome Measure
Skeletal muscle strength (handgrip strength test) [ Time Frame: Baseline to 14 weeks ]
Central Contacts
- Subrata Debnath, PhD210-567-4700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 |
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