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

NCT04246918 | Completed

• 1 other identifier: ILBS-BCAA-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease

Keywords

Chronic Liver Disease; Sarcopenia; Myostatin; Health related quality of life; muscle histology

Outcome Measures

Primary Outcomes (1)

• Improvement in the muscle mass

  Muscle mass change as assessed by DEXA scan will be done.

  3 months

Secondary Outcomes (19)

• Changes in the muscle fibre type composition

  3 months

• Changes in cross sectional area of muscle

  3 months

• Assessment of necrosis in muscle fibre

  3 Months

• Assessment of intramuscular fat deposition

  3 months

• Assessment of myoD

  3 month

Study Arms (2)

Standard Treatment Group

PLACEBO COMPARATOR

The patients would receive customized diet charts providing 30-35Kcal/ideal body wt/day and 1.5 gm protein/ideal body wt/day) describing the food items along with the quantity and approximate household measurements. Diet would be so planned for each patient keeping in mind the individual food habits and choices. This group would not receive any supplement other than the prescribed diet. Whey protein will be included in this group.

Dietary Supplement: Whey Protein concentrate powder

Intervention Arm

ACTIVE COMPARATOR

The patients would receive customized diet charts providing 30-35Kcal/ideal body wt/day and 1.5 gm protein/ideal body wt/day) describing the food items along with the quantity and approximate household measurements. Diet would be so planned for each patient keeping in mind the individual food habits and choices. In addition to the normal diet this group would receive 16gm of branched chain amino acid (BCAA) supplement (Commercial oral BCAA granules) daily in 4 divided doses, keeping the protein levels within the same range of 1.5 gm/Kg/day.

Dietary Supplement: Branched Chain Amino Acid

Interventions

Branched Chain Amino Acid DIETARY_SUPPLEMENT

Branched chain amino acid is a group of three amino acids known for there role in muscle growth.

Intervention Arm

Whey Protein concentrate powder DIETARY_SUPPLEMENT

Whey protein will be given to the standard treatment arm including in the same amount of 1.5gm/kg/IBW.

Standard Treatment Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with decompensated cirrhosis (CTP 7-9)
• Adult patients Age 18-60 years
• Patients with corrected BMI in the range \<22.9
• Those who give consent for muscle biopsy
• INR \<1.5 or 1.5-2.5 after correction with Vitamin K
• Platelets \> 80000
• All etiologies

You may not qualify if:

• Presence of overt hepatic encephalopathy
• Patients with co-morbidities e.g. acquired immunodeficiency syndrome, HCC, Other cancer, Diabetes Mellitus, chronic kidney disease, congestive heart disease , chronic respiratory disease
• Patients with alcohol intake in past 3 months
• Patients with TIPS
• Patients on steroids
• INR \>2.5
• Refusal to participate in the trial

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Amino Acids, Branched-Chain

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Puja Bhatia, MSc

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

• Jaya Benjamin, PhD

  Institute of Liver and Biliary Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As it is a nutritional intervention study masking either the participant or the investigator is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 29, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2022-03

Locations

IN (1)