Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients

NCT05259930 | Unknown DMC

• 2 other identifiers: 21143A0121/93
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Malnutrition and reduced muscle mass have been associated with poor outcomes in many disease conditions including severe inflammatory bowel disease, liver failure and cancers. Studies have shown that use of an amino acid supplement can specifically support muscle and nutritional health of patients with liver cirrhosis and malnutrition in general. The investigators will perform new novel non-invasive measurements of muscle mass and strength as well as inflammatory markers and record food diaries in the investigators patients with inflammatory bowel disease, cirrhosis of the liver and other gastroenterology disease impacting patient nutrition. The investigators hope to determine if of the addition of BCAA in addition to best practice nutrition supports for patients with cirrhosis will improve muscle mass and clinical outcomes in the investigators patient cohort including hospitalization, rate of decompensations, frailty score and quality of life for patients with liver cirrhosis. The investigators intend to investigate whether immune-metabolic profiles, circulating T-cells and circulating plasma cytokines (Afzal et al, J. Clin. Med. 2020) may act as biomarkers in combination with non-invasive novel markers of muscle mass in patients with chronic gastrointestinal illness, particularly cirrhosis to predict outcomes, and whether implementation of best practice nutritional supports with addition of Amino MP9 supplementation may impact functional outcomes. The immunometabolic profiles of these cohorts in relation to macrophage and T Cell function and differentiation have not been described previously. The investigators also hope to develop a system facilitating accurate assessments of nutritional status in gastroenterology patients and determine if there is correlation with objective clinical activity measured using endoscopy, faecal calprotectin or radiological evidence of inflammation, currently measured as part of standard practice. Sub-analysis will investigate potential association between longitudinal diet evaluation using EDIP (empirical dietary inflammatory pattern) score and disease activity, clinical remission and response to medical therapy, all influencing quality of life and patient related outcome measures. A prospective observational analysis of nutritional status and muscle mass or sarcopenia in patients attending gastroenterology services at Beaumont Hospital. Patients will be recruited from Gastroenterology and Hepatology outpatient clinics or inpatient capacity. Controls will be recruited from outpatient setting.

Conditions

Sarcopenia; Cirrhosis, Liver

Keywords

branched-chain amino acid

Outcome Measures

Primary Outcomes (6)

• Liver decompensation requiring hospital admission

  Decompensated cirrhosis is defined as a patient with cirrhosis who presents with an acute deterioration in liver function that can manifest with the following symptoms: hepatic encephalopathy (equal or greater than 2), sepsis, new ascites/increase ascites, clinical jaundice, acute kidney injury according to modified RIFLE criteria and signs of gastrointestinal bleeding including melaena, haematemesis or coffee-ground vomiting

  3 months

• Liver decompensation requiring hospital admission

  Decompensated cirrhosis is defined as a patient with cirrhosis who presents with an acute deterioration in liver function that can manifest with the following symptoms: hepatic encephalopathy (equal or greater than 2), sepsis, new ascites/increase ascites, clinical jaundice, acute kidney injury according to modified RIFLE criteria and signs of gastrointestinal bleeding including melaena, haematemesis or coffee-ground vomiting hepatic encephalopathy (equal or greater than 2), sepsis, new ascites/increase ascites, clinical jaundice , acute kidney injury according to modified RIFLE criteria and signs of gastrointestinal bleeding including melaena, haematemesis or coffee-ground vomiting

  6 months

• Anterior thigh muscle mass thickness

  Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)

  3 months

• Anterior thigh muscle mass thickness

  Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)

  6 months

• Segmental muscle mass

  Improvement in segmental muscle mass analysis through Bio-impedance analysis device (SECA device). Muscle mass of arms, legs and trunk will be measured in kilogram.

  3 months

• Segmental muscle mass

  Improvement in segmental muscle mass analysis through Bio-impedance analysis device (SECA device). Muscle mass of arms, legs and trunk will be measured in kilogram.

  6 months

Secondary Outcomes (7)

• Mortality

  6 months

• Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis

  3 months

• Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis

  6 months

• Improvement in frailty

  3 months

• Improvement in frailty

  6 months

Study Arms (3)

Chronic gastrointestinal disease (IBD and liver cirrhotic patients)

NO INTERVENTION

Liver cirrhotic patients to receive best practice nutritional assessment and supports

branched-chain amino acid (BCAA)

EXPERIMENTAL

Liver cirrhotic patients to receive best practice nutritional assessment and supports in addition to a 12-week course of BCAA supplementation

Other: Amino MP9

Healthy Control

NO INTERVENTION

Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease.

Interventions

Amino MP9 OTHER

Name used by Nualtra for their product of BCAA

branched-chain amino acid (BCAA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed cirrhosis (clinical or radiological diagnosis using liver biopsy, ultrasound/CT and/or transient elastography, Fibroscan)
• Age \> 18 years
• Child Pugh score ≥B7
• Active or recent (within the preceding 2 years) cirrhosis-related complication(s): including alcoholic hepatitis, ascites, variceal bleeding, spontaneous bacterial peritonitis, sepsis, encephalopathy, liver-related renal dysfunction, or hepatocellular carcinoma BCLC (Barcelona-Clinic Liver Cancer) stage A or B.

You may not qualify if:

• Active cancer (non-HCC)
• Advanced stage hepatocellular carcinoma (BCLC stage C or D)
• Pregnancy
• Breastfeeding/Lactation
• Lack of capacity for informed consent
• Hepatic Encephalopathy \> Grade 2 at recruitment
• Listed for liver transplant
• Consumption of anabolic steroids for purpose of muscle development

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead
• Nualtra: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland

Dublin, D02 YN77, Ireland

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Central Study Contacts

Ciara O'Connor

CONTACT

01 809 3880; ciaraaoconnor@rcsi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Center randomised controlled trial

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 2, 2022
• Study Start: March 2, 2022
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)