<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/NCT03831399</url>
  </required_header>
  <id_info>
    <org_study_id>H1524420647893</org_study_id>
    <nct_id>NCT03831399</nct_id>
  </id_info>
  <brief_title>Leucine Supplementation in Sarcopenic Older Individuals</brief_title>
  <official_title>Beneficial Effect of Leucine Supplementation in Muscular, Functional and Cognitive Functions in Sarcopenic Older Individuals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Armonea Group - La Saleta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bonusan BV</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</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>
      Caring with older people in west societies has becoming a challenge for all health&#xD;
      professional and any measure that can increase health or well-being will be ultimately&#xD;
      improve quality of life and life expectancy. Frailty is a geriatric syndrome describing&#xD;
      physical and functional decline that occurs as a consequence of certain diseases (e.g.,&#xD;
      cancer, chronic infection, etc.) but also even without disease. Frailty is characterized by&#xD;
      an increased risk for poor outcomes such as incident falls, fractures, disability,&#xD;
      comorbidity, health care expenditure and premature mortality. The aetiology of frailty is not&#xD;
      well understood but it has been associated with changes in several physiologic systems,&#xD;
      including inflammation, metabolic and micronutrients deficits.&#xD;
&#xD;
      The investigators wish to test with a confident perspective that any measured that improve&#xD;
      the efficiency of muscular system can prevent the progression of frailty syndrome and that&#xD;
      can have many others effects since it has been consistently demonstrated that a proper&#xD;
      muscular function in aging is associated with other signs and symptoms. Looking at the&#xD;
      literature, there are two clinical trials that evaluated the effect of leucine&#xD;
      supplementation in older individuals with beneficial effects. The investigators wish to&#xD;
      replicate those findings and to extend the analysis of the effect afforded by leucine&#xD;
      supplementation in sarcopenia, frailty and cognitive function in individuals living in&#xD;
      nursing homes in Valencia and province. This trial will show the eventual effects of leucine&#xD;
      supplementation in elderly people may be also useful to afford some beneficial effects&#xD;
      (sleep, cognitive function, depressed mood, balance and gait, etc) by modulating the function&#xD;
      of muscular and metabolic system and in reduce the progression of sarcopenia and loss of&#xD;
      muscular function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">October 14, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Administration of Leucine or placebo (microcrystalline cellulose) will be done twice/day in the morning and in the afternoon for 13 weeks measuring spoon of placebo. Both products will be delivered in white jars, without label, and will carry the patient number on the outside. Randomization of numbers to either placebo or verum product will take place by Bonusan and will be revealed to the researchers at the end of final phase.&#xD;
The administration of prebiotics or placebo will last 13 weeks except for appearance of side-effects related to the study. The side-effects will be recorded and consulted with Bonusan Research Staff.&#xD;
The researcher enrolled in the geriatric, psychological or analytical measurements will be blind to the drug treatment.&#xD;
After finishing the study period, the study the Director of the Research group (Dr. Omar Cauli) will ask Bonusan to reveal who participants received Leucine and those who received placebo.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Lean mass</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:&#xD;
Skeletal muscle mass index (kg/m2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:&#xD;
Handgrip Strength (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical performance</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:&#xD;
Walking speed (m/s)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine total, HDL and LDL cholesterol (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine glucose (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine creatinine (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine triglycerides (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
IL6 (pg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF-alfa</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
TNF-alfa (pg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-1</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
IGF-1 (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leucine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as leucine concentration (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as valine concentration (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isoleucine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as isoleucine concentration (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glutamine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as glutamine concentration (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B-alanine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as B-alanine concentration (mg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Albumine</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
albumine (g/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transthyretin</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
transthyretin (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myostatin</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:&#xD;
myostatin (ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:&#xD;
Body mass index (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body perimeters</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:&#xD;
Abdominal and calf perimeter (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as bioimpedance to know fat and lean mass (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as Charlson index score (absence of comorbidity: 0-1 points, low comorbidity: 2 points, and high comorbidity &gt; 3 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type and number of drugs used</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, the drugs consumed by each participant will be collected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait and balance</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Tinetti index Scale(0 to 28 points, 19-24 risk of falling, &lt;19 high risk of falling)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basic activities of daily living</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Barthel index Scale to measure the activities of daily living and mobility (o to 100 points, &lt; 60 dependence)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive performance</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Mini-mental score examination Scale (MMSE - 0 to 30 points, &lt;24 points cognitive impairment, &lt;21 mild cognitive impairment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Yesavage Scale for geriatric depression (0 to 15 points, &gt;5 points high risk of depression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced spirometry</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as forced spirometry parameters (measured with a spirometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscles strenght</measure>
    <time_frame>4 months</time_frame>
    <description>Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as maximal respiratory pressures (measured with a respiratory pressure gauge)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in control group will receive placebo (lactose) 6g/day in two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks.&#xD;
The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in intervention group will receive leucine 6g/day, in tin two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks.&#xD;
The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Leucine</intervention_name>
    <description>Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to walk alone or with help of a can or a walker&#xD;
&#xD;
          -  Age 60 years or older&#xD;
&#xD;
          -  Cognitive function equal or higher than 21points in Mini-mental examination score&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Institutionalized in nursing homes for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosed severe dementia&#xD;
&#xD;
          -  Severe psychiatric disease (i.e. schizophrenia)&#xD;
&#xD;
          -  Glomerular filtrate &lt;30 ml/min/1,73m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar Cauli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.mdpi.com/2072-6643/12/4/932</url>
    <description>Link to the main article published in Nutrients, March 2020</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>April 2, 2020</last_update_submitted>
  <last_update_submitted_qc>April 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frailty</keyword>
  <keyword>Aged</keyword>
  <keyword>Leucine</keyword>
  <keyword>Sarcopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data will be shared with other researchers</ipd_description>
  </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/NCT03831399
org study id: H1524420647893
nct id: NCT03831399
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Caring with older people in west societies has becoming a challenge for all health
      professional and any measure that can increase health or well-being will be ultimately
      improve quality of life and life expectancy. Frailty is a geriatric syndrome describing
      physical and functional decline that occurs as a consequence of certain diseases (e.g.,
      cancer, chronic infection, etc.) but also even without disease. Frailty is characterized by
      an increased risk for poor outcomes such as incident falls, fractures, disability,
      comorbidity, health care expenditure and premature mortality. The aetiology of frailty is not
      well understood but it has been associated with changes in several physiologic systems,
      including inflammation, metabolic and micronutrients deficits.

      The investigators wish to test with a confident perspective that any measured that improve
      the efficiency of muscular system can prevent the progression of frailty syndrome and that
      can have many others effects since it has been consistently demonstrated that a proper
      muscular function in aging is associated with other signs and symptoms. Looking at the
      literature, there are two clinical trials that evaluated the effect of leucine
      supplementation in older individuals with beneficial effects. The investigators wish to
      replicate those findings and to extend the analysis of the effect afforded by leucine
      supplementation in sarcopenia, frailty and cognitive function in individuals living in
      nursing homes in Valencia and province. This trial will show the eventual effects of leucine
      supplementation in elderly people may be also useful to afford some beneficial effects
      (sleep, cognitive function, depressed mood, balance and gait, etc) by modulating the function
      of muscular and metabolic system and in reduce the progression of sarcopenia and loss of
      muscular function.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study of phase I, pilot, prospective, multicentric, randomized, double blind and placebo-controlled
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Administration of Leucine or placebo (microcrystalline cellulose) will be done twice/day in the morning and in the afternoon for 13 weeks measuring spoon of placebo. Both products will be delivered in white jars, without label, and will carry the patient number on the outside. Randomization of numbers to either placebo or verum product will take place by Bonusan and will be revealed to the researchers at the end of final phase.
The administration of prebiotics or placebo will last 13 weeks except for appearance of side-effects related to the study. The side-effects will be recorded and consulted with Bonusan Research Staff.
The researcher enrolled in the geriatric, psychological or analytical measurements will be blind to the drug treatment.
After finishing the study period, the study the Director of the Research group (Dr. Omar Cauli) will ask Bonusan to reveal who participants received Leucine and those who received placebo.
measure: Lean mass
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:
Skeletal muscle mass index (kg/m2)
measure: Strength
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:
Handgrip Strength (kg)
measure: Physical performance
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated according to European Group of Working Sarcopenia in older people criteria:
Walking speed (m/s)
measure: Cholesterol
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine total, HDL and LDL cholesterol (mg/dL)
measure: Glucose
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine glucose (mg/dL)
measure: Creatinine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine creatinine (mg/dL)
measure: Triglycerides
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with a blood analysis to determine triglycerides (mg/dL)
measure: IL-6
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
IL6 (pg/mL)
measure: TNF-alfa
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
TNF-alfa (pg/mL)
measure: IGF-1
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
IGF-1 (mg/mL)
measure: Leucine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as leucine concentration (mg/mL)
measure: Valine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as valine concentration (mg/mL)
measure: Isoleucine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as isoleucine concentration (mg/mL)
measure: Glutamine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as glutamine concentration (mg/mL)
measure: B-alanine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as B-alanine concentration (mg/mL)
measure: Albumine
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
albumine (g/L)
measure: Transthyretin
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
transthyretin (mg/L)
measure: Myostatin
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, metabolic biomarkers related to sarcopenia and muscular function of all participants will be evaluated as:
myostatin (ng/mL)
measure: Body mass index
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:
Body mass index (kg/m2)
measure: Body perimeters
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as:
Abdominal and calf perimeter (cm)
measure: Body composition
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as bioimpedance to know fat and lean mass (kg)
measure: Comorbidities
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as Charlson index score (absence of comorbidity: 0-1 points, low comorbidity: 2 points, and high comorbidity > 3 points)
measure: Type and number of drugs used
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, the drugs consumed by each participant will be collected
measure: Gait and balance
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Tinetti index Scale(0 to 28 points, 19-24 risk of falling, <19 high risk of falling)
measure: Basic activities of daily living
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Barthel index Scale to measure the activities of daily living and mobility (o to 100 points, < 60 dependence)
measure: Cognitive performance
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Mini-mental score examination Scale (MMSE - 0 to 30 points, <24 points cognitive impairment, <21 mild cognitive impairment)
measure: Depression
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated with Yesavage Scale for geriatric depression (0 to 15 points, >5 points high risk of depression)
measure: Forced spirometry
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as forced spirometry parameters (measured with a spirometer)
measure: Respiratory muscles strenght
time frame: 4 months
description: Before starting and after finishing administration of Leucine supplement or placebo, all participants will be evaluated as maximal respiratory pressures (measured with a respiratory pressure gauge)
arm group label: Control Group
arm group type: Placebo Comparator
description: Subjects in control group will receive placebo (lactose) 6g/day in two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks.
The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant.
arm group label: Intervention Group
arm group type: Active Comparator
description: Subjects in intervention group will receive leucine 6g/day, in tin two doses, in two spoon at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks.
The product will be delivered in powder, in white jars, without label, and will only carry the patient number on the outside, 4 jars per participant.
intervention type: Dietary Supplement
intervention name: Leucine
description: Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
arm group label: Intervention Group
intervention type: Dietary Supplement
intervention name: Placebo
description: Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
arm group label: Control Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Omar Cauli, MD, PhD
role: Principal Investigator
affiliation: Universitat de Valencia
facility: 
country: Spain
url: https://www.mdpi.com/2072-6643/12/4/932
description: Link to the main article published in Nutrients, March 2020
responsible party type: Sponsor
mesh term: Sarcopenia
sharing ipd: No
ipd description: No data will be shared with other researchers