<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/NCT03784495</url>
  </required_header>
  <id_info>
    <org_study_id>1215/11122015</org_study_id>
    <nct_id>NCT03784495</nct_id>
  </id_info>
  <brief_title>Melatonin Plus Aminoacids for Sarcopenic Elderly</brief_title>
  <acronym>MelAASarc</acronym>
  <official_title>Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda di Servizi alla Persona di Pavia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda di Servizi alla Persona di Pavia</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body&#xD;
      composition, protein metabolism, strength and inflammation. The investigators performed a&#xD;
      Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people&#xD;
      (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1&#xD;
      mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g&#xD;
      eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body&#xD;
      composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of&#xD;
      protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the&#xD;
      4-week intervention&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 1, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Total Fat Mass and Total Free Fat Mass (DXA)</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured by DXA, using a Lunar Prodigy DXA (GE Medical Systems, Waukesha, WI). Free Fat mass and Fat mass of specific body regions were measured in kilograms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Handgrip Strenght</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Handgrip strength assessed using a Jamar dynamometer adhering to the standardized protocol recommended by the American Society of Hand Therapists. A weak handgrip was defined as &lt;30 kg for men and &lt;20 kg for women, based on the average value of the two handgrip measurements of the dominant hand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>At baseline (0)</time_frame>
    <description>Height measured in meters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Body Weight measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum proteins</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood lipids (total cholesterol and triglycerides)</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in High-sensitivity C-reactive protein (CRP)</measure>
    <time_frame>0, 30 days</time_frame>
    <description>High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in erythrocyte sedimentation rate (ESR)</measure>
    <time_frame>0, 30 days</time_frame>
    <description>Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycaemia</measure>
    <time_frame>0, 30 days</time_frame>
    <description>glycemia was expressed in mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mini Nutritional Assessment (MNA)</measure>
    <time_frame>0, 30 days</time_frame>
    <description>A mini nutritional assessment (MNA) was performed for all participants. The MNA uses 18 questions regarding simple measurements and a brief questionnaire involving an anthropometric assessment (weight, height and weight loss), a general assessment (lifestyle, medication and mobility), and a dietary assessment (number of meals, food and fluid intake, self-assessment of eating autonomy and self-perception of health and nutrition). Every answer give up to a maximum of 3 points. The sum of all points gives the total MNA. A maximum of 30 points can be achieved. A score of ≥ 24 points describes a well-nourished status. A score of 17 to 23.5 points indicates a risk of malnutrition, while less than 17 points indicates malnutrition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dietary intake</measure>
    <time_frame>Measures taken at day 1,2,3 and at day 28,29,30</time_frame>
    <description>A trained dietitian used a calibrated dietetic spring scale to weigh all foods served and returned for 3 consecutive days at the beginning and end of the study</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>Placebo (P)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Melatonin (M)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg/day of melatonin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Essential Aminoacids (eAA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 g/day of essential aminoacids</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Essential Aminoacids + Melatonin (eAAM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 g/day of essential aminoacids and 1 mg/day of melatonin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin 1mg</intervention_name>
    <description>1 mg/day 30 minutes before sleep</description>
    <arm_group_label>Melatonin (M)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Essential Aminoacids (eAA)</intervention_name>
    <description>4g/day of Essential Aminoacids during breakfast. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.</description>
    <arm_group_label>Essential Aminoacids (eAA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Essential Aminoacids + melatonin</intervention_name>
    <description>4g/day of Essential Aminoacids during breakfast + 1 mg/day of Melatonin 30 minutes before sleep. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.</description>
    <arm_group_label>Essential Aminoacids + Melatonin (eAAM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product</description>
    <arm_group_label>Placebo (P)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &gt; or equal 65 years&#xD;
&#xD;
          -  Sarcopenic patients, following the Rosetta Study criteria: Skeletal Muscle Index [SMI]&#xD;
             was &lt;7.23 kg/m2 in men and &lt;5.45 kg/m2 in women) and loss of strength, evaluated by&#xD;
             dynamometer and defined as &lt;30 kg for men and &lt;20 kg for women, using the average&#xD;
             value of the two handgrip measurements of the dominant hand.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute illnesses&#xD;
&#xD;
          -  severe liver dysfunction&#xD;
&#xD;
          -  severe heart dysfunction&#xD;
&#xD;
          -  severe kidney dysfunction&#xD;
&#xD;
          -  severe dementia&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  dysthyroidism&#xD;
&#xD;
          -  any endocrinopathies&#xD;
&#xD;
          -  neoplasia&#xD;
&#xD;
          -  patients treated with steroids&#xD;
&#xD;
          -  patients entirely unable to walk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariangela Rondanelli, Professor</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Mondino Foundation, Pavia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 21, 2018</last_update_submitted>
  <last_update_submitted_qc>December 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda di Servizi alla Persona di Pavia</investigator_affiliation>
    <investigator_full_name>Mariangela Rondanelli</investigator_full_name>
    <investigator_title>MD, Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcopenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be not available for 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/NCT03784495
org study id: 1215/11122015
nct id: NCT03784495
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body
      composition, protein metabolism, strength and inflammation. The investigators performed a
      Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people
      (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1
      mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g
      eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body
      composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of
      protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the
      4-week intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Total Fat Mass and Total Free Fat Mass (DXA)
time frame: 0, 30 days
description: Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured by DXA, using a Lunar Prodigy DXA (GE Medical Systems, Waukesha, WI). Free Fat mass and Fat mass of specific body regions were measured in kilograms.
measure: Change in Handgrip Strenght
time frame: 0, 30 days
description: Handgrip strength assessed using a Jamar dynamometer adhering to the standardized protocol recommended by the American Society of Hand Therapists. A weak handgrip was defined as <30 kg for men and <20 kg for women, based on the average value of the two handgrip measurements of the dominant hand
measure: Height
time frame: At baseline (0)
description: Height measured in meters
measure: Change in Body Weight
time frame: 0, 30 days
description: Body Weight measured in kilograms
measure: Change in serum proteins
time frame: 0, 30 days
description: Serum proteins and albumin were measured by automatic biochemical analyzer. They were reported as g/dl
measure: Change in blood lipids (total cholesterol and triglycerides)
time frame: 0, 30 days
description: Blood lipids (total cholesterol and triglycerides)were measured by automatic biochemical analyzer. They were reported as mg/dl
measure: Change in High-sensitivity C-reactive protein (CRP)
time frame: 0, 30 days
description: High-sensitivity C-reactive protein (CRP) was expressed in mg/dl.
measure: Change in erythrocyte sedimentation rate (ESR)
time frame: 0, 30 days
description: Erythrocyte sedimentation rate (ESR) was expressed in mm/hr.
measure: Change in glycaemia
time frame: 0, 30 days
description: glycemia was expressed in mg/dl
measure: Change in Mini Nutritional Assessment (MNA)
time frame: 0, 30 days
description: A mini nutritional assessment (MNA) was performed for all participants. The MNA uses 18 questions regarding simple measurements and a brief questionnaire involving an anthropometric assessment (weight, height and weight loss), a general assessment (lifestyle, medication and mobility), and a dietary assessment (number of meals, food and fluid intake, self-assessment of eating autonomy and self-perception of health and nutrition). Every answer give up to a maximum of 3 points. The sum of all points gives the total MNA. A maximum of 30 points can be achieved. A score of ≥ 24 points describes a well-nourished status. A score of 17 to 23.5 points indicates a risk of malnutrition, while less than 17 points indicates malnutrition.
measure: Change in dietary intake
time frame: Measures taken at day 1,2,3 and at day 28,29,30
description: A trained dietitian used a calibrated dietetic spring scale to weigh all foods served and returned for 3 consecutive days at the beginning and end of the study
arm group label: Placebo (P)
arm group type: Placebo Comparator
description: Placebo.
arm group label: Melatonin (M)
arm group type: Experimental
description: 1 mg/day of melatonin.
arm group label: Essential Aminoacids (eAA)
arm group type: Experimental
description: 4 g/day of essential aminoacids
arm group label: Essential Aminoacids + Melatonin (eAAM)
arm group type: Experimental
description: 4 g/day of essential aminoacids and 1 mg/day of melatonin
intervention type: Drug
intervention name: Melatonin 1mg
description: 1 mg/day 30 minutes before sleep
arm group label: Melatonin (M)
intervention type: Dietary Supplement
intervention name: Essential Aminoacids (eAA)
description: 4g/day of Essential Aminoacids during breakfast. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.
arm group label: Essential Aminoacids (eAA)
intervention type: Combination Product
intervention name: Essential Aminoacids + melatonin
description: 4g/day of Essential Aminoacids during breakfast + 1 mg/day of Melatonin 30 minutes before sleep. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.
arm group label: Essential Aminoacids + Melatonin (eAAM)
intervention type: Other
intervention name: Placebo
description: an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
arm group label: Placebo (P)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Mariangela Rondanelli, Professor
role: Study Director
affiliation: IRCCS Mondino Foundation, Pavia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda di Servizi alla Persona di Pavia
investigator full name: Mariangela Rondanelli
investigator title: MD, Associate Professor
mesh term: Sarcopenia
mesh term: Melatonin
sharing ipd: No
ipd description: IPD will be not available for other researchers