<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459091</url>
  </required_header>
  <id_info>
    <org_study_id>2112</org_study_id>
    <nct_id>NCT04459091</nct_id>
  </id_info>
  <brief_title>Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Stroke in Rehabilitation Phase</brief_title>
  <official_title>Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Patients With Cerebral Ictus in Rehabilitation Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituti Clinici Scientifici Maugeri SpA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pavia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituti Clinici Scientifici Maugeri SpA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In addition to its physiological functions, serum albumin plays a role of neuroprotection in&#xD;
      cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with&#xD;
      stroke due to the presence of a systemic inflammatory state and to the inadequacy of&#xD;
      protein-energy intake. The circulating levels of albumin have proven to be predictors of&#xD;
      functional recovery in ischemic stroke and cerebral hemorrhage.&#xD;
&#xD;
      In the present survey it is hypothesized that it is possible to significantly improve the&#xD;
      values of hypoalbuminemia by supplementation with essential amino acids and that, in the&#xD;
      second place, any increase in albumin may result in a strengthening of functional recovery in&#xD;
      patients with a stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In addition to its physiological functions, serum albumin plays a role of neuroprotection in&#xD;
      cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with&#xD;
      stroke due to the presence of a systemic inflammatory state and to the inadequacy of&#xD;
      protein-energy intake. In the patients admitted to the Montescano Neuromotor Rehabilitation&#xD;
      Division, the prevalence of hypoalbuminemia is high at the time of admission and remains&#xD;
      high, even if decreased, at discharge. The circulating levels of albumin have proven to be&#xD;
      predictors of functional recovery in ischemic stroke and cerebral hemorrhage. In the present&#xD;
      survey it is hypothesized that it is possible to significantly improve the values of&#xD;
      hypoalbuminemia by supplementation with essential amino acids and that, in the second place,&#xD;
      any increase in albumin may result in a strengthening of functional recovery in patients with&#xD;
      a stroke.&#xD;
&#xD;
      Several factors induce the use of free essential amino acids: they are the most efficient&#xD;
      inducers of protein synthesis and albumin is a protein; free essential amino acids and not&#xD;
      those contained in proteins allow a more reliable use of the isoleucine and tryptophan, true&#xD;
      nutrients limiting the hepatic synthesis of albumin; the free essential amino acids have a&#xD;
      faster and complete intestinal absorption of the essential amino acids derived from protein&#xD;
      digestion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">September 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Albumin Levels</measure>
    <time_frame>eight weeks</time_frame>
    <description>Number of patients who at discharge show levels of albuminemia&gt; 0.35 gr / dl (normal level)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure</measure>
    <time_frame>eight weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Stroke Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Amino essential acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Amino Essential Acid</intervention_name>
    <description>8 gr die in two administration</description>
    <arm_group_label>Amino essential acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>8 gr die in two administration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first episode of cerebral stroke&#xD;
&#xD;
          -  first taken in rehabilitation after hospitalization in the acute department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neoplasia&#xD;
&#xD;
          -  long-term corticosteroid therapy (&gt; 3 weeks) in the pre-event period and at the time&#xD;
             of admission to the rehabilitation department&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ICS Maugeri IRCCS, U.O. di Rieducazione e Recupero Funzionale di Montescano</name>
      <address>
        <city>Montescano</city>
        <state>Pavia</state>
        <zip>27040</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>12390513</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27856112</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>31412042</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Serum Albumin</keyword>
  <keyword>Essential Amino Acid</keyword>
  <keyword>Functional Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459091
org study id: 2112
nct id: NCT04459091
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Serum Albumin Levels
time frame: eight weeks
description: Number of patients who at discharge show levels of albuminemia> 0.35 gr / dl (normal level)
measure: Functional Independence Measure
time frame: eight weeks
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.
arm group label: Amino essential acids
arm group type: Experimental
description: oral supplementation with a mixture of amino essential acids 8 gr die in two administrations for six weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo consisting in isocaloric product containing maltodextrins in two administrations for six weeks
intervention type: Dietary Supplement
intervention name: Amino Essential Acid
description: 8 gr die in two administration
arm group label: Amino essential acids
intervention type: Dietary Supplement
intervention name: placebo
description: 8 gr die in two administration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
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.
PMID: 12390513
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.
PMID: 27856112
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.
PMID: 31412042
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No