<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/NCT03827499</url>
  </required_header>
  <id_info>
    <org_study_id>2131/2018</org_study_id>
    <nct_id>NCT03827499</nct_id>
  </id_info>
  <brief_title>HMB Supplementation in Addition to Multicomponent Exercise in Old Adults</brief_title>
  <acronym>HEAL</acronym>
  <official_title>Effects of β-hydroxy-β-methylbutyrate (HMB) Supplementation in Addition to Multicomponent Exercise in Old Adults Living in Nursing Homes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Murcia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Murcia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB)&#xD;
      supplementation are, separately, effective in improving old adult's health and palliate&#xD;
      functional metabolic diseases in the elderly. However, the true effect of HMB supplementation&#xD;
      combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim&#xD;
      of the HEAL study is to assess the effects of the combination of a daily multicomponent&#xD;
      exercise and resistance training intervention in addition to HMB supplementation on old&#xD;
      adults' health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB)&#xD;
      supplementation are, separately, effective in improving old adult's health and palliate&#xD;
      functional metabolic diseases in the elderly. However, the true effect of HMB supplementation&#xD;
      combined with a tailored exercise program in frail old adults is still unknown.&#xD;
&#xD;
      Thus, the aim of the HEAL study is to assess the effects of the combination of a daily&#xD;
      multicomponent exercise and resistance training intervention in addition to HMB&#xD;
      supplementation on old adults' health.&#xD;
&#xD;
      The findings of the HEAL study will help professionals from public health systems to identify&#xD;
      cost-effectiveness and innovative actions to improve older people's health and quality of&#xD;
      life, and endorse exercise practice in older adults living in nursing homes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2019</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 30, 2023</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Summary scores range from 0-12 and higher scores denote higher physical performance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Handgrip strength (kg)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Using a dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lower-body strength (kg)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Seated leg press one-repetition maximun test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in upper-body strength (kg)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Vertical bench press one-repetition maximun test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lower-body strength power output (m/s)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Seated leg press load-velocity profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in upper-body strength power output (m/s)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Vertical bench press load-velocity profile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frailty (score)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Frailty phenotype determination using Fried's criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lean body mass (kg)</measure>
    <time_frame>Baseline to Week 25</time_frame>
    <description>Change in lean body mass using dual energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in lipid profile</measure>
    <time_frame>Baseline to Week 25</time_frame>
    <description>Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glycaemic profile</measure>
    <time_frame>Baseline to Week 25</time_frame>
    <description>Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Thyroid-Stimulating Hormone (mIU/L)</measure>
    <time_frame>Baseline to Week 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disability (Lawton index scores)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Disability in instrumental activities of daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disability (Barthel index scores)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Disability in basic activities of daily living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Comorbidity (score)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function (score)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Using the Mini-Mental State Examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression (score)</measure>
    <time_frame>Baseline to 25 Weeks</time_frame>
    <description>Using the 15-item Yesavage geriatric depression</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Aging</condition>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Ex-HMB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HMB dietary supplementation and Multicomponent physical exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NoEx-HMB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HMB Dietary supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ex-Plac</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multicomponent physical exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>HMB dietary supplementation</intervention_name>
    <description>Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention</description>
    <arm_group_label>Ex-HMB</arm_group_label>
    <arm_group_label>NoEx-HMB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multicomponent physical exercise program</intervention_name>
    <description>Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.</description>
    <arm_group_label>Ex-HMB</arm_group_label>
    <arm_group_label>Ex-Plac</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged ≥70 years living in a nursing home&#xD;
&#xD;
          -  Be able to follow an active physical rehabilitation program&#xD;
&#xD;
          -  Be able to read and wright&#xD;
&#xD;
          -  Voluntary participation&#xD;
&#xD;
          -  Capable and willing to provide an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute heart attack (recent 3-6 months) or unstable angina&#xD;
&#xD;
          -  Uncontrolled atrial or ventricular arrhythmias&#xD;
&#xD;
          -  Aortic dissecting aneurysm&#xD;
&#xD;
          -  Severe aortic stenosis&#xD;
&#xD;
          -  Acute endocarditis / pericarditis&#xD;
&#xD;
          -  Uncontrolled high blood pressure (&gt;180/100 mmHg)&#xD;
&#xD;
          -  Acute thromboembolism&#xD;
&#xD;
          -  Acute or severe heart failure&#xD;
&#xD;
          -  Acute or severe respiratory failure&#xD;
&#xD;
          -  Uncontrolled postural hypotension&#xD;
&#xD;
          -  Uncontrolled acute decompensated diabetes mellitus or low blood sugar&#xD;
&#xD;
          -  A recent fracture in the last month.&#xD;
&#xD;
          -  Coincident participation in any intervention trial&#xD;
&#xD;
          -  HMB contraindication, intolerance, or allergy&#xD;
&#xD;
          -  Community-dwelling people&#xD;
&#xD;
          -  Have regularly performed exercise (&gt;20 minutes &gt;3 days/week) in the last 3 months&#xD;
&#xD;
          -  Malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in&#xD;
             situ of the uterine cervix)&#xD;
&#xD;
          -  Revascularization within 1 year&#xD;
&#xD;
          -  Severe loss of vision, hearing, or communicative ability&#xD;
&#xD;
          -  Conditions preventing cooperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Sport Sciences</name>
      <address>
        <city>Murcia</city>
        <state>San Javier</state>
        <zip>30720</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Murcia</investigator_affiliation>
    <investigator_full_name>Javier Courel Ibáñez</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <!-- 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/NCT03827499
org study id: 2131/2018
nct id: NCT03827499
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB)
      supplementation are, separately, effective in improving old adult's health and palliate
      functional metabolic diseases in the elderly. However, the true effect of HMB supplementation
      combined with a tailored exercise program in frail old adults is still unknown. Thus, the aim
      of the HEAL study is to assess the effects of the combination of a daily multicomponent
      exercise and resistance training intervention in addition to HMB supplementation on old
      adults' health.
Evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (HMB)
      supplementation are, separately, effective in improving old adult's health and palliate
      functional metabolic diseases in the elderly. However, the true effect of HMB supplementation
      combined with a tailored exercise program in frail old adults is still unknown.

      Thus, the aim of the HEAL study is to assess the effects of the combination of a daily
      multicomponent exercise and resistance training intervention in addition to HMB
      supplementation on old adults' health.

      The findings of the HEAL study will help professionals from public health systems to identify
      cost-effectiveness and innovative actions to improve older people's health and quality of
      life, and endorse exercise practice in older adults living in nursing homes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in physical functional performance based on the Short Physical Performance Battery (SPPB) score
time frame: Baseline to 25 Weeks
description: Summary scores range from 0-12 and higher scores denote higher physical performance.
measure: Change in Handgrip strength (kg)
time frame: Baseline to 25 Weeks
description: Using a dynamometer
measure: Change in lower-body strength (kg)
time frame: Baseline to 25 Weeks
description: Seated leg press one-repetition maximun test
measure: Change in upper-body strength (kg)
time frame: Baseline to 25 Weeks
description: Vertical bench press one-repetition maximun test
measure: Change in lower-body strength power output (m/s)
time frame: Baseline to 25 Weeks
description: Seated leg press load-velocity profile
measure: Change in upper-body strength power output (m/s)
time frame: Baseline to 25 Weeks
description: Vertical bench press load-velocity profile
measure: Change in frailty (score)
time frame: Baseline to 25 Weeks
description: Frailty phenotype determination using Fried's criteria
measure: Change in lean body mass (kg)
time frame: Baseline to Week 25
description: Change in lean body mass using dual energy x-ray absorptiometry
measure: Change in lipid profile
time frame: Baseline to Week 25
description: Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL)
measure: Change in glycaemic profile
time frame: Baseline to Week 25
description: Plasma glucose, insulin and glycosylated haemoglobin (all in mg/dL)
measure: Change in Thyroid-Stimulating Hormone (mIU/L)
time frame: Baseline to Week 25
measure: Change in Disability (Lawton index scores)
time frame: Baseline to 25 Weeks
description: Disability in instrumental activities of daily living.
measure: Change in Disability (Barthel index scores)
time frame: Baseline to 25 Weeks
description: Disability in basic activities of daily living
measure: Change in Comorbidity (score)
time frame: Baseline to 25 Weeks
description: When a participant presents two or more geriatric syndromes from a list of selected geriatric syndromes
measure: Change in cognitive function (score)
time frame: Baseline to 25 Weeks
description: Using the Mini-Mental State Examination
measure: Change in depression (score)
time frame: Baseline to 25 Weeks
description: Using the 15-item Yesavage geriatric depression
arm group label: Ex-HMB
arm group type: Experimental
description: HMB dietary supplementation and Multicomponent physical exercise program
arm group label: NoEx-HMB
arm group type: Experimental
description: HMB Dietary supplementation
arm group label: Ex-Plac
arm group type: Placebo Comparator
description: Multicomponent physical exercise program
arm group label: Controls
arm group type: No Intervention
description: No intervention
intervention type: Dietary Supplement
intervention name: HMB dietary supplementation
description: Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
arm group label: Ex-HMB
arm group label: NoEx-HMB
intervention type: Other
intervention name: Multicomponent physical exercise program
description: Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
arm group label: Ex-HMB
arm group label: Ex-Plac
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Murcia
investigator full name: Javier Courel Ibáñez
investigator title: Ph.D