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Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase

Primary Purpose

Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Amino Essential Acid
placebo
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke Rehabilitation focused on measuring Serum Albumin, Essential Amino Acid, Functional Recovery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first episode of cerebral stroke
  • first taken in rehabilitation after hospitalization in the acute department

Exclusion Criteria:

  • neoplasia
  • long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department

Sites / Locations

  • ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amino essential acids

Placebo

Arm Description

oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks

placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks

Outcomes

Primary Outcome Measures

Serum Albumin Levels
Number of patients who at discharge show levels of albuminemia> 0.35 gr / dl (normal level)

Secondary Outcome Measures

Functional Independence Measure
The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability. Range total FIM score 18-126. High score corresponds to better outcome.

Full Information

First Posted
June 22, 2020
Last Updated
October 20, 2021
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04459091
Brief Title
Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase
Official Title
Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Patients With Cerebral Ictus in Rehabilitation Phase
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.
Detailed Description
In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. In the patients admitted to the Montescano Neuromotor Rehabilitation Division, the prevalence of hypoalbuminemia is high at the time of admission and remains high, even if decreased, at discharge. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke. Several factors induce the use of free essential amino acids: they are the most efficient inducers of protein synthesis and albumin is a protein; free essential amino acids and not those contained in proteins allow a more reliable use of the isoleucine and tryptophan, true nutrients limiting the hepatic synthesis of albumin; the free essential amino acids have a faster and complete intestinal absorption of the essential amino acids derived from protein digestion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Serum Albumin, Essential Amino Acid, Functional Recovery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amino essential acids
Arm Type
Experimental
Arm Description
oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino Essential Acid
Intervention Description
8 gr die in two administration
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
8 gr die in two administration
Primary Outcome Measure Information:
Title
Serum Albumin Levels
Description
Number of patients who at discharge show levels of albuminemia> 0.35 gr / dl (normal level)
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Functional Independence Measure
Description
The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability. Range total FIM score 18-126. High score corresponds to better outcome.
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first episode of cerebral stroke first taken in rehabilitation after hospitalization in the acute department Exclusion Criteria: neoplasia long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department
Facility Information:
Facility Name
ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12390513
Citation
Rodriguez de Turco EB, Belayev L, Liu Y, Busto R, Parkins N, Bazan NG, Ginsberg MD. Systemic fatty acid responses to transient focal cerebral ischemia: influence of neuroprotectant therapy with human albumin. J Neurochem. 2002 Nov;83(3):515-24. doi: 10.1046/j.1471-4159.2002.01121.x.
Results Reference
background
PubMed Identifier
27856112
Citation
Kimura Y, Yamada M, Kakehi T, Itagaki A, Tanaka N, Muroh Y. Combination of Low Body Mass Index and Low Serum Albumin Level Leads to Poor Functional Recovery in Stroke Patients. J Stroke Cerebrovasc Dis. 2017 Feb;26(2):448-453. doi: 10.1016/j.jstrokecerebrovasdis.2016.10.008. Epub 2016 Nov 14.
Results Reference
background
PubMed Identifier
31412042
Citation
Aquilani R, Maestri R, Boselli M, Achilli MP, Arrigoni N, Bruni M, Dossena M, Verri M, Buonocore D, Pasini E, Barbieri A, Boschi F. The relationship between plasma amino acids and circulating albumin and haemoglobin in postabsorptive stroke patients. PLoS One. 2019 Aug 14;14(8):e0219756. doi: 10.1371/journal.pone.0219756. eCollection 2019.
Results Reference
result

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Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase

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