Chronic Kidney Disease, Sarcopenia
Conditions
Keywords
Valine, Essential amino acid, Metabolic effects
Brief summary
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.
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.
Interventions
Sponsors
The University of Texas Health Science Center at San Antonio
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study design will consist of a single center, prospective, randomized crossover open label pilot study
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle strength (handgrip strength test) | 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 |
| Muscle mass | Baseline to 14 weeks | Change from baseline muscle mass using a bioelectrical impedance analysis to the end of each 6-Week intervention |
| Physical performance (4-meter Walk Gait Speed Test or 4MWT) | Baseline to 14 weeks | Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention |
| Incidence of patient-reported symptoms | Baseline to 14 weeks | Change from baseline (number of symptoms) to the end of each 6-Week intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale | 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 |
Countries
United States
Contacts
CONTACTSubrata Debnath, PhD
PRINCIPAL_INVESTIGATORSubrata Debnath, PhD
University of Texas Health Science Center San Antonio
Outcome results
None listed