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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:
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.
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.
patients will be randomly allocated within the two groups:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolife Plus by Piemme Pharmatech, Italy | Dietary Supplement | A nutritional supplement containing whey protein, vitamin D, carnitine, HMB, perilla, arginine, coenzyme Q10, inositol) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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); | 12 months |
| Improved QoL |
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Inclusion Criteria:
Patients affected by Liver cirrhosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuele Rinninella, PI | Fondazione Policlinico Gemelli, Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emanuele Rinninella | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D008103 | Liver Cirrhosis |
| D007732 | Kwashiorkor |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Differences in quality of life indices (QLQ-C30, QLQ-CR29, QLQ-CAX24, QLQ-PRT20) between the two groups. |
| 12 months |
| Differences in terms of plasmatic metabolites | Differences between the 2 intervention groups in terms of plasma metabolites. | 12 months |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D000067011 | Severe Acute Malnutrition |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |