SarcopeniaLIFRAMINNCT06573229
LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
A study testing Aminolife Plus by Piemme Pharmatech, Italy in people with Sarcopenia and Cirrhosis, Liver, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this clinical trial is to compare food for special medical purposes (Aminolife Plus, by Piemme Pharmatech) vs. placebo in improving muscle mass and function in a cohort of cirrhotic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Cirrhosis, Liver, Malnutrition; Protein
- What is being tested?
- Aminolife Plus by Piemme Pharmatech, Italy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2024to 30 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by Liver cirrhosis
- at any stage of Child (A-B-C) with or without hepatocarcinoma
- SARC-F suggestive of risk of sarcopenia
- Age > 18 years
- Ability to perform Liver Frailty Index test
- Informed consent to participate in the study.
Who cannot join
- SARC-F not suggestive of sarcopenia
- inability to perform Liver Frailty Index test
- absence of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare food for special medical purposes (Aminolife Plus, by Piemme Pharmatech) vs. placebo in improving muscle mass and function in a cohort of cirrhotic patients.
The main questions it aims to answer are:
Read more
- whether functional ability improves in cirrhotic-sarcopenic patients two months after taking the supplement compared with those not taking the supplement.
- whether weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle as per bioimpedance analysis (BIA) in cirrhotic-sarcopenic patients increase two months after taking the supplement compared with those not taking the supplement.
- to assess quality-of-life indices in the two groups.
- to assess differences in groups in terms of plasma metabolite production in the two groups
This is a spontaneous, no PROFIT, pilot interventional study in the form of a randomized clinical trial (RCT), double-blind.
All patients will undergo simple sarcopenia risk identification questions (SARC-F test). All patients recognized to be at risk will be randomized to receive.
- nutritional counseling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counseling according to guidelines + placebo 20 g/day (4 scoops) for a total of 60 days (2 months).
The manufacturing company will provide the product and placebo free of charge. Patients will undergo, at the first visit and at the follow-up visit anthropometric measurements and body composition assessment (by bioimpedance analysis).
In addition, 1 blood sample for metabolomic analysis will be taken at the same visits.
The study will last 12 months.
Read the detailed description
patients will be randomly allocated within the two groups:
- nutritional counselling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counselling according to guidelines + placebo 20 g/day (4 scoops)
The patients will be randomly allocated into two groups: the control group who will not take the treatment and the experimental group who will take the supplement. In detail, patients in the experimental group, in association with nutritional counselling, will take Aminolife plus 20 g/day (4 scoops) for two months (T0-T2).
Patients in the control group, in combination with nutritional counselling, will take placebo 20 g/day (4 scoops) for two months (T0-T2).
The division into the 2 groups will follow a block randomisation algorithm according to the Random Sorting procedure. The allocation sequence will be generated by means of the PASS2022 software.17 The allocation operator will be 'blinded' to the allocation group, just as the operator applying the treatment will not be involved in the evaluation of patients and results.
- Conditions
- Sarcopenia, Cirrhosis, Liver, Malnutrition; Protein
- Being tested
- Aminolife Plus by Piemme Pharmatech, Italy
- Medical subject headings
- Sarcopenia, Liver Cirrhosis, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolife Plus by Piemme Pharmatech, ItalyDietary supplement
A nutritional supplement containing whey protein, vitamin D, carnitine, HMB, perilla, arginine, coenzyme Q10, inositol)
| Study group | Role | What they receive |
|---|---|---|
| Aminolife Plus | Experimental | Food supplement based on milk protein serum (Isolac Instant), acetyl-carnitine, hydroxy-methyl-butyrate, arginine, inositol, coenzyme Q10 and extracts of perilla, maca and mallow. Perilla supports the body's natural defences, maca has a tonic and metabolic support action and mallow has an emollient and soothing action (digestive system, urinary tract). Calcium, vitamin D and vitamin K2 complete the formulation. Calcium contributes to energy metabolism and is necessary for maintaining normal bones. Vitamin D modulates the immune system and contributes to regular muscle function. Vitamin aK2 contributes to proper blood clotting and maintenance of normal bones. Receives: Dietary Supplement: Aminolife Plus by Piemme Pharmatech, Italy |
| Placebo | Placebo comparator | It is an inactive substance or treatment that has no therapeutic effect and is often used as a control in clinical trials. Receives: Dietary Supplement: Aminolife Plus by Piemme Pharmatech, Italy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved functional capacity (Liver Frailty Index)
Improved functional capacity in cirrhotic-sarcopenic patients, assessed by using the Liver Frailty Index test, which has already been validated in the literature and includes 3 continuous parameters (Handgrip strenght test, Chair Stand Test and Balance test).
Measured: 12 months
Secondary outcomes (3)
Improved anthropometric and bioelectrical values and comparing the two
Differences between the two groups in weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle, as per bioimpedance analysis (BIA);
Measured: 12 months
Improved QoL
Differences in quality of life indices (QLQ-C30, QLQ-CR29, QLQ-CAX24, QLQ-PRT20) between the two groups.
Measured: 12 months
Differences in terms of plasmatic metabolites
Differences between the 2 intervention groups in terms of plasma metabolites.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start2 Aug 2024
- Primary completion30 Jun 2025
- Study completion30 Oct 2025
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.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinninella Emanuele, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Emanuele Rinninella, PI, Principal investigator, Fondazione Policlinico Gemelli, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573229
- Sponsor's protocol ID
- 6409 - LIFRAMIN
- Acronym
- LIFRAMIN
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIver FRAilty Management IN Cirrhosis (LIFRAMIN)
- ClinicalTrials.gov ID
- NCT06573229
- Acronym / sponsor ID
- LIFRAMIN / 6409 - LIFRAMIN
- Conditions
- Sarcopenia, Cirrhosis, Liver, Malnutrition; Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 27 Aug 2024 (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.
The goal of this clinical trial is to compare food for special medical purposes (Aminolife Plus, by Piemme Pharmatech) vs. placebo in improving muscle mass and function in a cohort of cirrhotic patients.
The main questions it aims to answer are:
- whether functional ability improves in cirrhotic-sarcopenic patients two months after taking the supplement compared with those not taking the supplement.
- whether weight, body mass index (BMI), lean mass, muscle mass, metabolically active mass, and phase angle as per bioimpedance analysis (BIA) in cirrhotic-sarcopenic patients increase two months after taking the supplement compared with those not taking the supplement.
- to assess quality-of-life indices in the two groups.
- to assess differences in groups in terms of plasma metabolite production in the two groups
This is a spontaneous, no PROFIT, pilot interventional study in the form of a randomized clinical trial (RCT), double-blind.
All patients will undergo simple sarcopenia risk identification questions (SARC-F test). All patients recognized to be at risk will be randomized to receive.
- nutritional counseling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counseling according to guidelines + placebo 20 g/day (4 scoops) for a total of 60 days (2 months).
The manufacturing company will provide the product and placebo free of charge. Patients will undergo, at the first visit and at the follow-up visit anthropometric measurements and body composition assessment (by bioimpedance analysis).
In addition, 1 blood sample for metabolomic analysis will be taken at the same visits.
The study will last 12 months.
Detailed description
patients will be randomly allocated within the two groups:
- nutritional counselling according to guidelines + Aminolife plus 20 g/day (4 scoops) vs.
- nutritional counselling according to guidelines + placebo 20 g/day (4 scoops)
The patients will be randomly allocated into two groups: the control group who will not take the treatment and the experimental group who will take the supplement. In detail, patients in the experimental group, in association with nutritional counselling, will take Aminolife plus 20 g/day (4 scoops) for two months (T0-T2).
Patients in the control group, in combination with nutritional counselling, will take placebo 20 g/day (4 scoops) for two months (T0-T2).
The division into the 2 groups will follow a block randomisation algorithm according to the Random Sorting procedure. The allocation sequence will be generated by means of the PASS2022 software.17 The allocation operator will be 'blinded' to the allocation group, just as the operator applying the treatment will not be involved in the evaluation of patients and results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminolife Plus | Experimental | Dietary Supplement: Aminolife Plus by Piemme Pharmatech, ItalyFood supplement based on milk protein serum (Isolac Instant), acetyl-carnitine, hydroxy-methyl-butyrate, arginine, inositol, coenzyme Q10 and extracts of perilla, maca and mallow. Perilla supports the body's natural defences, maca has a tonic and metabolic support action and mallow has an emollient and soothing action (digestive system, urinary tract). Calcium, vitamin D and vitamin K2 complete the formulation. Calcium contributes to energy metabolism and is necessary for maintaining normal bones. Vitamin D modulates the immune system and contributes to regular muscle function. Vitamin aK2 contributes to proper blood clotting and maintenance of normal bones. |
| Placebo | Placebo comparator | Dietary Supplement: Aminolife Plus by Piemme Pharmatech, ItalyIt is an inactive substance or treatment that has no therapeutic effect and is often used as a control in clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients affected by Liver cirrhosis
- at any stage of Child (A-B-C) with or without hepatocarcinoma
- SARC-F suggestive of risk of sarcopenia
- Age > 18 years
- Ability to perform Liver Frailty Index test
Key exclusion criteria (3 listed)
- SARC-F not suggestive of sarcopenia
- inability to perform Liver Frailty Index test
- absence of 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 |
|---|---|---|
| Aminolife Plus by Piemme Pharmatech, ItalyA nutritional supplement containing whey protein, vitamin D, carnitine, HMB, perilla, arginine, coenzyme Q10, inositol) | Dietary supplement | Aminolife Plus, Placebo |
Primary outcome
Improved functional capacity (Liver Frailty Index)
Time frame: 12 months
Improved functional capacity in cirrhotic-sarcopenic patients, assessed by using the Liver Frailty Index test, which has already been validated in the literature and includes 3 continuous parameters (Handgrip strenght test, Chair Stand Test and Balance test).
3 secondary outcomes
Improved anthropometric and bioelectrical values and comparing the two
Time frame: 12 months
Improved QoL
Time frame: 12 months
Differences in terms of plasmatic metabolites
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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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.
Emanuele Rinninella, PI principal investigator
Fondazione Policlinico Gemelli, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminolife Plus by Piemme Pharmatech, Italy in people with Sarcopenia and Cirrhosis, Liver, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 2026. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved functional capacity (Liver Frailty Index) (time frame: 12 months). 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 25 Sep 2026.