An interventional study of Amino MP9 in Sarcopenia and Cirrhosis, Liver, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Treatment
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.
The investigators objectives are summarised as,
Objective 1:
The investigators review 25-30 new patients, and approximately 120 return patients across 4 weekly clinics. These include approximately 40 patients with chronic liver disease or cirrhosis. In order to test validity of non-invasive markers of muscle mass including BIA device and thigh ultrasound in specific patient populations, the investigators propose recruitment of 100 patients and 30 controls.
Objective 2:
The investigators propose recruitment of 50 patients with cirrhosis to receive nutrition support plus Amino MP9 (BCAA supplementation), 50 patients with cirrhosis to receive nutrition support alone and 30 controls.
The following criteria are set for recruitment of patients into this study:
Inclusion Criteria
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.
Exclusion Criteria
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
In this study patients will divided recruited patients into 3 different arms, as follows:
Arm 1 (n=50): Patients with chronic liver disease and >F4 fibrosis on imaging (n=50) to receive best practice nutritional assessment and supports.
Arm 2 (n=50): Patients with chronic liver disease and >F4 fibrosis on imaging, to receive best practice nutritional assessment and supports in addition to a 12-week course of daily Amino MP9, BCAA supplement
Arm 3 (n=30): Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease.
The investigators measurable outcomes includes:
Primary Outcome
Secondary Outcome
Patients identified as suitable for recruitment will be invited to participate in this study which entails comprehensive nutritional assessment in addition to current standard medical practices and investigations {routine weight (in kg) and BMI(kg/m²)} at each hospital attendance. Patients with liver cirrhosis will be randomised 1:1 to receive either standard of care with nutrition assessment or nutrition assessment plus Amino MP9 supplementation. Patients in these groups and additionally, patients with chronic gastrointestinal diseases will undergo below assessments with regular dietetic analysis and review (currently not available due to resource limitations) to determine whether a prognostic score and cost benefit analysis of strict implementations of nutritional recommendations relates to prognosis. Completion at 0, 3, 12, 24 weeks.
Additional nutrition assessment offered will include:
Balance assessment
Immunometabolic Profile at at 0, 3, 12 and 24 weeks
-> Plasma cytokine (IL 1, 6, 8, 10, 23, 17, TNF), myostatin, leptin, ghrelin and adiponectin analysis. Immunometabolic circulating T-cell and macrophage profile
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 130 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Liver cirrhotic patients to receive best practice nutritional assessment and supports
Liver cirrhotic patients to receive best practice nutritional assessment and supports in addition to a 12-week course of BCAA supplementation
Other: Amino MP9
Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease.
Name used by Nualtra for their product of BCAA
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
Time frame: 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
Time frame: 6 months
Anterior thigh muscle mass thickness
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Time frame: 3 months
Anterior thigh muscle mass thickness
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Mortality
Time frame: 6 months
Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis
Impact of BCAA on immune system this included measurements of (IL 1, 6, 8, 10, 23, 17, TNF), myostatin, leptin, ghrelin and adiponectin analysis. These will be measured with flow cytometry. Immunometabolic circulating T-cell and macrophage profile with flow cytometry. Measurements will be calculated with pg/mL scale.
Time frame: 3 months
Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis
Impact of BCAA on immune system this included measurements of (IL 1, 6, 8, 10, 23, 17, TNF), myostatin, leptin, ghrelin and adiponectin analysis. These will be measured with flow cytometry. Immunometabolic circulating T-cell and macrophage profile with flow cytometry. Measurements will be calculated with pg/mL scale.
Time frame: 6 months
Improvement in frailty
Improvement in frailty of liver cirrhotic patient and their quality of life based on liver frailty index { (-0.330 × gender - adjusted grip strength in kilogram) + (-2.529 × number of chair stands per seconds) + (-0.040 × balance time in second) + 6 }
Time frame: 3 months
Improvement in frailty
Improvement in frailty of liver cirrhotic patient and their quality of life based on liver frailty index { (-0.330 × gender - adjusted grip strength in kilogram) + (-2.529 × number of chair stands per seconds) + (-0.040 × balance time in second) + 6 }
Time frame: 6 months
Improvement in quality of life
Quality of life will be assessed with validated questionnaire, CLD-Q. This is consistent of 29 questions and it will assess patient's quality of life 2 weeks prior to assessments.
Time frame: 3 months
Improvement in quality of life
Quality of life will be assessed with validated questionnaire, CLD-Q. This is consistent of 29 questions and it will assess patient's quality of life 2 weeks prior to assessments.
Time frame: 6 months
Plan to share: No — There is no consent or ethical approval for sharing IPD
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Royal College of Surgeons, Ireland