<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/NCT02240511</url>
  </required_header>
  <id_info>
    <org_study_id>CLIC003</org_study_id>
    <nct_id>NCT02240511</nct_id>
  </id_info>
  <brief_title>Resistance Exercise Program and Branched Chain Amino Acid Supplementation in Heart Failure Patients</brief_title>
  <official_title>Changes in Body Composition in Heart Failure Patients After a Resistance Exercise Program and Branched Chain Amino Acid Supplementation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal&#xD;
      and metabolic complications known as &quot;Cardiac Cachexia&quot; (CC). In the development of CC there&#xD;
      is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause&#xD;
      a decrease of fat free mass and fat mass. These changes in body composition might be reversed&#xD;
      with a therapeutic combination of resistance exercise and branched chain amino acid&#xD;
      supplementation (BCAA). Thus the purpose of this study is evaluate changes in body&#xD;
      composition after a resistance exercise program and BCAA supplementation in patients with HF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure (HF) is a complex syndrome which results from structural and/or functional&#xD;
      alterations that limit the ability to respond to physiological demands(1,2).These&#xD;
      abnormalities involve metabolic and neuro-hormonal factors such as tumor necrosis factor-α&#xD;
      (TNF-α), one of the most important catabolic cytokines related with changes in body&#xD;
      composition, interleukin 1 (IL-1), IL-6, interferon Y, and transmission growth factor β&#xD;
      (3-9), which produce catabolic and anabolic imbalance and promote loss of fat free mass (FFM)&#xD;
      with or without loss of fat mass (FM) in patients with HF. This syndrome is called &quot;Cardiac&#xD;
      Cachexia&quot; (CC) (10). Signs and symptoms such as fatigue, anorexia and decreased muscle&#xD;
      strength reflect altered body composition (9, 10). There are two possible ways to counteract&#xD;
      these catabolic factors and restore body compartments. In one of them, protein&#xD;
      supplementation promotes protein synthesis and inhibits proteolysis (3,11,12); in the other&#xD;
      resistance exercise (RE) increases muscle mass and muscle strength, maintaining heart rate&#xD;
      (13,14). Previous studies report the association of protein supplementation (15-17) and&#xD;
      exercise (18-23) with changes in muscle strength in some cases and exercise capacity in HF&#xD;
      patients. However, these therapies were not combined, and the studies did not provide enough&#xD;
      information about changes in body composition. Based on these reports, our hypothesis is that&#xD;
      the combination of RE and protein supplementation in form of branched chain amino acids&#xD;
      (BCAA) might have an anabolic effect in patients with HF since the supplementation of BCAA&#xD;
      could be helpful as &quot;fuel&quot; during the exercise and maintain the muscle mass metabolism (24).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation.</measure>
    <time_frame>Baseline, 3 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Resistance Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resistance Exercise (RE) therapy was divided in four parts: stretching: arms, hands, wrists, legs, knees and ankles, each one for 10 - 20 seconds with resting intervals of 5 seconds (4 series), warming and flexion: the same muscle groups, making small circles forward and backward for 5 - 10 seconds with resting intervals of 5 seconds (4 series), resistance exercises: flexion, contractions and twisting of the same muscle groups worked in the two previous sections. In this part resistance was increased with the aid of dumbbells (500 g - 1500 g), barbells and bands, and patients performed the same exercises with 15 - 20 repetitions with resting intervals of 10 seconds. (4 series), relaxation: involved the same exercises as &quot;stretching&quot; to rest all muscle groups worked.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RE and BCAA Supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RE: Resistance Exercise Resistance Exercise therapy was the same as in the Active Comparator&#xD;
Branched Chain Aminoacids Amino 2000 BCAA (PRONAT® laboratory) supplementation group received 180 packets of 5 grams (g)and ingested 10 g/day (5 g after breakfast and 5 g before RE)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>RE and BCAA Supplementation</intervention_name>
    <description>RE: Resistance Exercise BCAA: Branched Chain Aminoacids</description>
    <arm_group_label>RE and BCAA Supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Exercise</intervention_name>
    <arm_group_label>Resistance Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  More than 18 years&#xD;
&#xD;
          -  Confirmed stable heart failure (2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No myocardial revascularization&#xD;
&#xD;
          -  Unstable angina or stroke in the previous 3 months&#xD;
&#xD;
          -  With no other chronic illness which contributed to loss of muscle mass (arthritis,&#xD;
             renal failure, cancer, HIV) previous study inclusion&#xD;
&#xD;
          -  Extra cardiac conditions that made patients unable to perform exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan A Pineda, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nestor A Sánchez, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lilia Castillo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arturo Orea, MD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rocio Cervantes, Ms</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Keirns D Candace, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Massachusetts General Hospital Interpreter Services</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Ocampo, Mr</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karla Quiroz, Ms</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mónica Tenorio, Ms</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Ronquillo, Mr</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>September 12, 2014</last_update_submitted>
  <last_update_submitted_qc>September 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</investigator_affiliation>
    <investigator_full_name>LILIA CASTILLO MARTINEz</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Body Composition</keyword>
  <keyword>Amino Acids Supplementation</keyword>
  <keyword>Resistance Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT02240511
org study id: CLIC003
nct id: NCT02240511
lead sponsor: 
has dmc: Yes
Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal
      and metabolic complications known as "Cardiac Cachexia" (CC). In the development of CC there
      is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause
      a decrease of fat free mass and fat mass. These changes in body composition might be reversed
      with a therapeutic combination of resistance exercise and branched chain amino acid
      supplementation (BCAA). Thus the purpose of this study is evaluate changes in body
      composition after a resistance exercise program and BCAA supplementation in patients with HF.
Heart failure (HF) is a complex syndrome which results from structural and/or functional
      alterations that limit the ability to respond to physiological demands(1,2).These
      abnormalities involve metabolic and neuro-hormonal factors such as tumor necrosis factor-α
      (TNF-α), one of the most important catabolic cytokines related with changes in body
      composition, interleukin 1 (IL-1), IL-6, interferon Y, and transmission growth factor β
      (3-9), which produce catabolic and anabolic imbalance and promote loss of fat free mass (FFM)
      with or without loss of fat mass (FM) in patients with HF. This syndrome is called "Cardiac
      Cachexia" (CC) (10). Signs and symptoms such as fatigue, anorexia and decreased muscle
      strength reflect altered body composition (9, 10). There are two possible ways to counteract
      these catabolic factors and restore body compartments. In one of them, protein
      supplementation promotes protein synthesis and inhibits proteolysis (3,11,12); in the other
      resistance exercise (RE) increases muscle mass and muscle strength, maintaining heart rate
      (13,14). Previous studies report the association of protein supplementation (15-17) and
      exercise (18-23) with changes in muscle strength in some cases and exercise capacity in HF
      patients. However, these therapies were not combined, and the studies did not provide enough
      information about changes in body composition. Based on these reports, our hypothesis is that
      the combination of RE and protein supplementation in form of branched chain amino acids
      (BCAA) might have an anabolic effect in patients with HF since the supplementation of BCAA
      could be helpful as "fuel" during the exercise and maintain the muscle mass metabolism (24).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation.
time frame: Baseline, 3 month
arm group label: Resistance Exercise
arm group type: Active Comparator
description: Resistance Exercise (RE) therapy was divided in four parts: stretching: arms, hands, wrists, legs, knees and ankles, each one for 10 - 20 seconds with resting intervals of 5 seconds (4 series), warming and flexion: the same muscle groups, making small circles forward and backward for 5 - 10 seconds with resting intervals of 5 seconds (4 series), resistance exercises: flexion, contractions and twisting of the same muscle groups worked in the two previous sections. In this part resistance was increased with the aid of dumbbells (500 g - 1500 g), barbells and bands, and patients performed the same exercises with 15 - 20 repetitions with resting intervals of 10 seconds. (4 series), relaxation: involved the same exercises as "stretching" to rest all muscle groups worked.
arm group label: RE and BCAA Supplementation
arm group type: Experimental
description: RE: Resistance Exercise Resistance Exercise therapy was the same as in the Active Comparator
Branched Chain Aminoacids Amino 2000 BCAA (PRONAT® laboratory) supplementation group received 180 packets of 5 grams (g)and ingested 10 g/day (5 g after breakfast and 5 g before RE)
intervention type: Dietary Supplement
intervention name: RE and BCAA Supplementation
description: RE: Resistance Exercise BCAA: Branched Chain Aminoacids
arm group label: RE and BCAA Supplementation
intervention type: Other
intervention name: Resistance Exercise
arm group label: Resistance Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Juan A Pineda, MSc
role: Principal Investigator
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Nestor A Sánchez, MSc
role: Study Director
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Lilia Castillo, PhD
role: Study Director
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Arturo Orea, MD
role: Study Director
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Rocio Cervantes, Ms
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Keirns D Candace, MD
role: Study Chair
affiliation: Massachusetts General Hospital Interpreter Services
last name: Carlos Ocampo, Mr
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Karla Quiroz, Ms
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Mónica Tenorio, Ms
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
last name: Alberto Ronquillo, Mr
role: Study Chair
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
investigator full name: LILIA CASTILLO MARTINEz
investigator title: PhD
mesh term: Heart Failure