Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients
NCT ID: NCT05259930
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
130 participants
INTERVENTIONAL
2022-03-02
2025-08-31
Brief Summary
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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.
Detailed Description
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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
1. Decompensation requiring hospital admission, surgery or medical intervention.
2. Improvement in anterior thigh muscle mass scores on ultrasound and non-invasive markers of muscle mass using SECA analysis
Secondary Outcome
1. Mortality
2. Impact of BCAA supplementation on immunometabolic markers in cirrhosis
3. Improvement in frailty and quality of life
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:
1. Food frequency questionnaires (FFQ) (subsequent calculation of EDIP score)
2. Mid abdominal circumference measurement
3. Hand-grip strength
4. Sit-to-stand timed test
5. Mid-thigh circumference measurement
6. Gait speed test
7. Bilateral anterior thigh muscle mass via ultrasound
8. Muscle mass and strength through BIA device
9. Balance assessment
* quality of life score assessment through CLD-Q questionnaire
* For cirrhotic cohort the investigators will monitor level of encephalopathy through trail and stroop tests.
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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chronic gastrointestinal disease (IBD and liver cirrhotic patients)
Liver cirrhotic patients to receive best practice nutritional assessment and supports
No interventions assigned to this group
branched-chain amino acid (BCAA)
Liver cirrhotic patients to receive best practice nutritional assessment and supports in addition to a 12-week course of BCAA supplementation
Amino MP9
Name used by Nualtra for their product of BCAA
Healthy Control
Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease.
No interventions assigned to this group
Interventions
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Amino MP9
Name used by Nualtra for their product of BCAA
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Nualtra
UNKNOWN
Royal College of Surgeons, Ireland
OTHER
Responsible Party
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Locations
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Royal College of Surgeons in Ireland
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Ciara O'Connor, MSc
Role: primary
Other Identifiers
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21/93
Identifier Type: OTHER
Identifier Source: secondary_id
21143A01
Identifier Type: -
Identifier Source: org_study_id