<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/NCT03024125</url>
  </required_header>
  <id_info>
    <org_study_id>1.733.512</org_study_id>
    <nct_id>NCT03024125</nct_id>
  </id_info>
  <brief_title>High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains</brief_title>
  <official_title>Effect of Normal and High Protein Diets in Lean Mass, Adiposity, and Strength in Postmenopausal Women Practitioners of Resistance Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of different types of diets (high and normal protein) on lean&#xD;
      and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two&#xD;
      groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8&#xD;
      protein g/body mass/day). The same training will be performed for both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both groups will undergo the same training protocol, differing only on the protein content of&#xD;
      the diet. The dietary assessment will be made through the 24-hour food recall, being&#xD;
      conducted at the beginning, middle and end of the intervention. Resistance exercises for&#xD;
      upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug,&#xD;
      6-minutes and 400 meters will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the lean mass of postmenopausal women practicing strength exercise</measure>
    <time_frame>Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the fat mass of postmenopausal women practicing strength exercise</measure>
    <time_frame>Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on strength of postmenopausal women practicing strength exercise</measure>
    <time_frame>Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Sarcopenia</condition>
  <arm_group>
    <arm_group_label>High protein diet (HP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diet with 1.2 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal protein diet (NP)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Diet with 0.8 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High protein</intervention_name>
    <description>To observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups.</description>
    <arm_group_label>High protein diet (HP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal protein</intervention_name>
    <description>To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes</description>
    <arm_group_label>Normal protein diet (NP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.</description>
    <arm_group_label>High protein diet (HP)</arm_group_label>
    <arm_group_label>Normal protein diet (NP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in the postmenopausal period (menopausal for at least one year, confirmed by&#xD;
             laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);&#xD;
&#xD;
          -  Healthy;&#xD;
&#xD;
          -  Who agree to participate and sign the consent term.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The one who does not provide the necessary information for the development of the&#xD;
             study;&#xD;
&#xD;
          -  Present orthopedic limitations;&#xD;
&#xD;
          -  Patients with previously diagnosed and treatment of diseases such as type II diabetes&#xD;
             mellitus, hypertension and cardiovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erick P de Oliveira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Uberlandia</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Erick Prado de Oliveira</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>lean mass</keyword>
  <keyword>postmenopausal</keyword>
  <keyword>protein</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>
  </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/NCT03024125
org study id: 1.733.512
nct id: NCT03024125
lead sponsor: 
has dmc: Yes
This study evaluates the effect of different types of diets (high and normal protein) on lean
      and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two
      groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8
      protein g/body mass/day). The same training will be performed for both groups.
Both groups will undergo the same training protocol, differing only on the protein content of
      the diet. The dietary assessment will be made through the 24-hour food recall, being
      conducted at the beginning, middle and end of the intervention. Resistance exercises for
      upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug,
      6-minutes and 400 meters will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in the lean mass of postmenopausal women practicing strength exercise
time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
measure: Changes in the fat mass of postmenopausal women practicing strength exercise
time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
measure: Changes on strength of postmenopausal women practicing strength exercise
time frame: Before and immediately after the intervention (initial moment and 10 weeks after start of the intervention)
arm group label: High protein diet (HP)
arm group type: Experimental
description: Diet with 1.2 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups
arm group label: Normal protein diet (NP)
arm group type: Placebo Comparator
description: Diet with 0.8 protein g/kg body mass/day for postmenopausal women practitioners of resistance exercise. The physical strength training will be performed equally by both groups
intervention type: Other
intervention name: High protein
description: To observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups.
arm group label: High protein diet (HP)
intervention type: Other
intervention name: Normal protein
description: To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes
arm group label: Normal protein diet (NP)
intervention type: Other
intervention name: Training
description: The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.
arm group label: High protein diet (HP)
arm group label: Normal protein diet (NP)
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Erick P de Oliveira, PhD
role: Principal Investigator
affiliation: Federal University of Uberlandia
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Erick Prado de Oliveira
investigator title: PhD
mesh term: Sarcopenia
sharing ipd: No