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NCT04246918: BCAA-CLD

Effect of BCAA Supplementation on Muscle Mass, Muscle Quality and Molecular Markers of Muscle Regeneration in CLD Patients

Completed NA Last updated 31 January 2023
What this trial tests

NA trial testing Branched Chain Amino Acid in Chronic Liver Disease in 60 participants. Completed in 30 September 2022.

Timeline
1 June 2020
Primary endpoint
30 September 2022
30 September 2022

Quick facts

Lead sponsorInstitute of Liver and Biliary Sciences, India
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date1 June 2020
Primary completion30 September 2022
Estimated completion30 September 2022
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Liver and Biliary Sciences, India

Who can join

Adults 18 to 60, any sex, with Chronic Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Loss of muscle mass (sarcopenia) is a major complication in a patient with cirrhosis, impacting the disease outcome, quality of life and survival. Cirrhotics lose muscle mass (MM) while waiting for liver transplant (LT) and even after LT, impacting the outcome of LT. Moreover, LT is elusive for majority of patients in India. The pathophysiology of muscle loss is complicated, multifactorial, interlinked and primarily nutrition driven, which gives clues for targeted therapeutic modalities other than feeding alone. Experimental studies have instilled faith in BCAA in successfully counteracting the pathogenesis of muscle loss. But there is lack of convincing data from clinical studies with direct evidence on muscle growth per se.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting the JAK2/STAT3 Pathway-Can We Compare It to the Two Faces of the God Janus?
    Jaśkiewicz A, Domoradzki T, Pająk B. · · 2020 · cited 32× · PMID 33158194 · DOI 10.3390/ijms21218261
  2. Sarcopenia in chronic kidney disease: from bench to bedside.
    Kim DW, Song SH. · · 2023 · cited 18× · PMID 37077132 · DOI 10.3904/kjim.2022.338
  3. Emerging Treatment Options for Sarcopenia in Chronic Liver Disease.
    Kim Y. · · 2021 · cited 17× · PMID 33803020 · DOI 10.3390/life11030250

Verify or expand the search:

Other trials of Branched Chain Amino Acid

Trials testing the same drug.

Other recruiting trials for Chronic Liver Disease

Currently open trials in the same condition.

Other Institute of Liver and Biliary Sciences, India trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04246918.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing