Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573229
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
LIver FRAilty Management IN Cirrhosis LIFRAMIN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
LIver FRAilty Management IN Cirrhosis LIFRAMIN
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFRAMIN
Brief 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
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
1 nutritional counseling according to guidelines Aminolife plus 20 gday 4 scoops vs
2 nutritional counseling according to guidelines placebo 20 gday 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
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
1 nutritional counseling according to guidelines Aminolife plus 20 gday 4 scoops vs
2 nutritional counseling according to guidelines placebo 20 gday 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
1 nutritional counselling according to guidelines Aminolife plus 20 gday 4 scoops vs
2 nutritional counselling according to guidelines placebo 20 gday 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 gday 4 scoops for two months T0-T2
Patients in the control group in combination with nutritional counselling will take placebo 20 gday 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 software17 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
1 nutritional counselling according to guidelines Aminolife plus 20 gday 4 scoops vs
2 nutritional counselling according to guidelines placebo 20 gday 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 gday 4 scoops for two months T0-T2
Patients in the control group in combination with nutritional counselling will take placebo 20 gday 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 software17 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None