SarcopeniaNCT05259930
Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients
A study testing Amino MP9 in people with Sarcopenia and Cirrhosis, Liver, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Cirrhosis, Liver
- What is being tested?
- Amino MP9
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteIreland
- Study dates
- 2 Mar 2022to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Royal College of Surgeons in Ireland
Dublin, D02 YN77
Ciara O'Connor, MSc, (01) 809 3880, ciaraaoconnor@rcsi.com
Karen Boland, PhD
About this study
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.
Read more
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.
Read the detailed description
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
- Decompensation requiring hospital admission, surgery or medical intervention.
- Improvement in anterior thigh muscle mass scores on ultrasound and non-invasive markers of muscle mass using SECA analysis
Secondary Outcome
- Mortality
- Impact of BCAA supplementation on immunometabolic markers in cirrhosis
- 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:
- Food frequency questionnaires (FFQ) (subsequent calculation of EDIP score)
- Mid abdominal circumference measurement
- Hand-grip strength
- Sit-to-stand timed test
- Mid-thigh circumference measurement
- Gait speed test
- Bilateral anterior thigh muscle mass via ultrasound
- Muscle mass and strength through BIA device
- 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
- Sarcopenia, Cirrhosis, Liver
- Being tested
- Amino MP9
- Keywords
- branched-chain amino acid
- Medical subject headings
- Sarcopenia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino MP9Other
Name used by Nualtra for their product of BCAA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Amino MP9 |
| Healthy Control | No intervention | Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Anterior thigh muscle mass thickness
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Measured: 3 months
Anterior thigh muscle mass thickness
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (7)
Mortality
Measured: 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.
Measured: 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.
Measured: 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 }
Measured: 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 }
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start2 Mar 2022
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Center randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Nualtra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259930
- Sponsor's protocol ID
- 21143A01
- Other IDs
- 21/93
- Status last verified
- Dec 2023
- First submitted
- 24 Jan 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no consent or ethical approval for sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Assessment and Intervention on Outcomes in Liver Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT05259930
- Acronym / sponsor ID
- 21143A01
- Conditions
- Sarcopenia, Cirrhosis, Liver
- Keywords
- branched-chain amino acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Nualtra
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Decompensation requiring hospital admission, surgery or medical intervention.
- Improvement in anterior thigh muscle mass scores on ultrasound and non-invasive markers of muscle mass using SECA analysis
Secondary Outcome
- Mortality
- Impact of BCAA supplementation on immunometabolic markers in cirrhosis
- 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:
- Food frequency questionnaires (FFQ) (subsequent calculation of EDIP score)
- Mid abdominal circumference measurement
- Hand-grip strength
- Sit-to-stand timed test
- Mid-thigh circumference measurement
- Gait speed test
- Bilateral anterior thigh muscle mass via ultrasound
- Muscle mass and strength through BIA device
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single Center randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Amino MP9Liver cirrhotic patients to receive best practice nutritional assessment and supports in addition to a 12-week course of BCAA supplementation |
| Healthy Control | No intervention | –Controls attending gastroenterology outpatient or endoscopy services with no chronic inflammatory GI disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Active cancer (non-HCC)
- Advanced stage hepatocellular carcinoma (BCLC stage C or D)
- Pregnancy
- Breastfeeding/Lactation
- Lack of capacity for informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino MP9Name used by Nualtra for their product of BCAA | Other | branched-chain amino acid (BCAA) |
Primary outcome
Liver decompensation requiring hospital admission
Time frame: 3 months
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
Liver decompensation requiring hospital admission
Time frame: 6 months
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
Anterior thigh muscle mass thickness
Time frame: 3 months
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Anterior thigh muscle mass thickness
Time frame: 6 months
Improvement in anterior thigh muscle mass thickness on ultrasound (in millimetre)
Segmental muscle mass
Time frame: 3 months
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.
Segmental muscle mass
Time frame: 6 months
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.
7 secondary outcomes
Mortality
Time frame: 6 months
Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis
Time frame: 3 months
Impact of BCAA supplementation on cytokines and immunometabolic markers in cirrhosis
Time frame: 6 months
Improvement in frailty
Time frame: 3 months
Improvement in frailty
Time frame: 6 months
Improvement in quality of life
Time frame: 3 months
Improvement in quality of life
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No. There is no consent or ethical approval for sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino MP9 in people with Sarcopenia and Cirrhosis, Liver, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ciara O'Connor (01 809 3880, ciaraaoconnor@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver decompensation requiring hospital admission (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.