Branched-chain Amino Acids to Improve Sarcopenia in Patients With Advanced Chronic Kidney Disease (BOOST-CKD)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Skeletal muscle strength (handgrip strength test)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability of participant to understand and the willingness to sign a written informed consent document.
- •Males and females of age 45-75 yrs
- •Hand grip strength of <26 kg for male and <16 kg for female
- •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.
- •Not on dialysis and is not expected to initiate dialysis or any kidney replacement therapy in next 4 months
- •Receiving standard of care including dietary recommendation for diabetes, hypertension, CKD, and other comorbidities
- •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
- •Serum HCO3 concentration 20-29 mmol/L based on two consecutive recent routine labs
- •HbA1c 7-9% based on most recent routine lab
- •Serum albumin ≥3.8 g/dL based on most recent routine lab
- •Blood hemoglobin ≥10 g/dL based on most recent routine lab
- •Willingness to adhere to lifestyle management, including diet and exercise as recommended by care providers, and to the study intervention, procedures, and regimen.
排除标准
- •Any known history of hypersensitivity/intolerance to valine or specific amino acids
- •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
- •With a cardiac pacemaker and/or an implantable cardioverter-defibrillator
- •Significant arthritis prohibiting strength test and walk gait speed test
- •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
- •Currently taking any protein supplements
- •Pregnant, lactating, childbearing women
- •History of Maple syrup urine disease (MSUD)
- •Scheduled for kidney transplantation or dialysis in next 4 months
- •Current participation in another interventional trial
- •Documented noncompliance with regard to clinic visits, medications, and lifestyle management.
- •Documentation of current or history of substance abuse.
研究组 & 干预措施
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).
干预措施: EEA (Drug)
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.
干预措施: Valine (Drug)
结局指标
主要结局
Skeletal muscle strength (handgrip strength test)
时间窗: 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
时间窗: 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)
时间窗: Baseline to 14 weeks
Change from baseline 4MWT (measured in second) to the end of each 6-Week intervention
Incidence of patient-reported symptoms
时间窗: Baseline to 14 weeks
Change from baseline (number of symptoms) to the end of each 6-Week intervention
次要结局
- Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia subscale(Baseline to 14 weeks)
研究者
Subrata Debnath
Assistant Professor
The University of Texas Health Science Center at San Antonio