Table 1.
Current and emerging therapeutic interventions for sarcopenia with chronic liver diseases observed in clinical trials.
| Target or Mechanism of Action |
Intervention | Sponsor/Collaborator | Clinical Phase | Indication | Status | NCT Number | Year | Title | |
|---|---|---|---|---|---|---|---|---|---|
| Start | End | ||||||||
| Testosterone | Testosterone undecanoate | Institute of Liver and Biliary Sciences, India | NA | Liver cirrhosis | Recruiting | NCT03995251 | 2019 | 2020 | Efficacy and Safety of Testosterone Therapy in Improving Sarcopenia in Men with Cirrhosis: A Randomized Controlled Trial |
| Behavior | Exercise | University of California, San Francisco/Johns Hopkins University, Duke University | NA | End-stage liver disease, sarcopenia, liver cirrhosis | Completed | NCT02367092 | 2016 | 2019 | Exercise Intervention in Liver Transplant Patients |
| Behavior | Exercise | Memorial Hospital Groups | NA | End-stage liver disease, chronic liver failure, sarcopenia |
Completed | NCT04546048 | 2018 | 2019 | The Early Strength Training Exercise Therapy in Liver Recipients: Protocol for an Observational Feasibility Trial |
| Behavior | Pulmonary rehabilitation exercise, home-based exercise | Mayo Clinic | NA | End-stage liver disease | Recruiting | NCT03266575 | 2018 | Ongoing | Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End-Stage Liver Disease? |
| Dietary supplement | Amino acid infusion | Rigshospitalet, Denmark/Hvidovre University Hospital | NA | Cirrhosis | Completed | NCT02132962 | 2014 | 2015 | Sarcopenia and Cirrhosis |
| Dietary supplement | BCAA | Puerta de Hierro University Hospital | NA | Sarcopenia | Completed | NCT04073693 | 2017 | 2019 | Characterization of the Nutritional Status in the Patient with Liver Cirrhosis and Impact of a Nutritional Intervention with Nutritional Supplements with BCAA vs. Standard Treatment in the Subgroup of Patients with Sarcopenia |
| Dietary supplement | BCAA | Dayanand Medical College and Hospital | 4 | Liver cirrhosis | Recruiting | NCT03633279 | 2018 | 2020 | Treatment of Sarcopenia Improves the Muscle Mass and Muscle Strength of Patients with Liver Cirrhosis—Child C: A Randomized Double Blind Control Trial |
| Dietary supplement | BCAA | Institute of Liver and Biliary Sciences, India | NA | Chronic liver disease | Recruiting | NCT04246918 | 2020 | Ongoing | Effect of Branched Chain Amino Acids Supplementation on Muscle Mass, Muscle Quality, and Molecular Markers of Muscle Regeneration in Patients With Chronic Liver Disease: A Randomized Controlled Trial |
| Dietary supplement | HMB | University of Roma La Sapienza | NA | Sarcopenia | Completed | NCT03234920 | 2015 | 2018 | Effects of β-Hydroxy-β-methylbutyrate (HMB) Supplementation after Liver Transplantation: Randomized and Controlled Pilot Study |
| Dietary supplement | CaHMB | Shanghai Zhongshan Hospital | NA | Sarcopenia, liver cirrhosis | Unknown | NCT03605147 | 2018 | 2019 | The Effect of Calcium β-Hydroxy-β-methylbutyrate Supplementation in Sarcopenia in Liver Cirrhosis: A Randomized Double-Blind Controlled Trial |
| Dietary supplement | HMB | University of Roma La Sapienza | NA | Sarcopenia, liver cirrhosis | Recruiting | NCT03892070 | 2019 | 2020 | β-Hydroxy-β-methylbutyrate Supplementation and Physical Activity in Liver Cirrhosis: A Controlled Trial |
| Dietary supplement | Ensure Plus Advance, Ensure High Protein | Instituto Aragones de Ciencias de la Salud/Refbio2: Trans-Pyrenean Cooperation Network for Biomedical Research | NA | Sarcopenia, liver cirrhosis | Active, not recruiting | NCT03285217 | 2017 | 2019 | HMB for Denutrition in Patients with Cirrhosis (HEPATIC) |
| Dietary supplement | Fresubin energy (dietary protein energy supplement) | Medical University of Graz | NA | Sarcopenia, liver cirrhosis | Recruiting | NCT03080129 | 2017 | Ongoing | Microbiome and Sarcopenia in Patients with Liver Cirrhosis: A Prospective Controlled Cohort Study |
| Dietary supplement | Medically tailored meals, protein supplements | University of Michigan | NA | Sarcopenia, liver cirrhosis, hepatic encephalopathy, ascites | Recruiting | NCT04675775 | 2021 | Ongoing | Medically Tailored Meals to Prevent Recurrent Hepatic Encephalopathy: The BRAINFOOD Pilot Trial |
| Multifactorial intervention | Home exercise, BCAA supplements, multispecies probiotic | Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau | NA | Sarcopenia, liver cirrhosis, frailty syndrome (FS) | Recruiting | NCT04243148 | 2020 | Ongoing | Frailty in Patients with Cirrhosis: Prognostic Value of the Phase Angle in Hospitalized Patients and Effect of a Multifactorial Intervention (Home Exercise, Branched-chain Amino Acids, and Probiotics) |
| Multifactorial intervention | Physical training program, behavioral modification therapy, nutritional consultation | University of Arkansas | NA | End-stage liver disease, liver transplant, sarcopenia, cirrhosis | Completed | NCT02776553 | 2016 | 2020 | A Physical Activity Program in End-Stage Liver Disease: Pilot Study Assessing Changes in Physical Fitness, Sarcopenia, and the Metabolic Profile |
Data were presented in the Clinicaltrials.gov on 1 February 2021. Abbreviation: BCAA, branched chain amino acid; HMB, β-hydroxy-β-methylbutyrate; NA, not applicable.