<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/NCT03785002</url>
  </required_header>
  <id_info>
    <org_study_id>69787617.0.0000.5327</org_study_id>
    <nct_id>NCT03785002</nct_id>
  </id_info>
  <brief_title>Comparison of the Increment of Neuromuscular Parameters in Vegetarians and Non-vegetarians</brief_title>
  <official_title>Comparison of Strength and Muscle Thickness of Recreational Sports Individuals With Vegetarian or Non-vegetarian Food Standards Adequate in Proteins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      A strength training session promotes increased muscle sensitivity to protein synthesis, which&#xD;
      lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to&#xD;
      the training session of approximately 20g or 0.24g / kg of high-quality protein in the same&#xD;
      meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular&#xD;
      strength between vegetarian and omnivorous athletes with adequate protein intake to reach&#xD;
      this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or&#xD;
      omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the&#xD;
      Term of Consent, participants will be submitted to anthropometric and body composition&#xD;
      assessment (via DEXA), neuromuscular tests [(ie, muscle strength - 1RM, peak torque of knee&#xD;
      extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to&#xD;
      compare the results of the study, and to compare the results of the covariance analysis&#xD;
      (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the&#xD;
      initial values of the force and the initial muscular thickness as covariables, the other&#xD;
      parameters will be presented in the form of mean and standard deviation or median, the&#xD;
      differences will be considered significant for values of p &lt;0, 05. Expected to find no&#xD;
      differences in strength and muscle thickness between vegetarians and omnivores after adequate&#xD;
      protein intake.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Thickness (mm)</measure>
    <time_frame>At the14th week of study participation.</time_frame>
    <description>To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal strength (kg)</measure>
    <time_frame>At the 14th week of study participation.</time_frame>
    <description>To compare maximal strength (kg), using the one- repetition maximum test (1RM) for bilateral knee extension exercises. Each subject's maximal load was determined with no more than five attempts and an adequate amount of recovery time was permitted between each attempt (3-5min). Each valid repetition was considered when subjects performed full knee extension with proper technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric peak torque (PTiso) (N.m)</measure>
    <time_frame>At the 14th week of study participation.</time_frame>
    <description>To compare knee extensors Isometric peak torque (N.m), defined as the highest value of the torque recorded during unilateral knee extension, using an isokinetic dynamometer, among vegetarian and omnivorous participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat free mass (g)</measure>
    <time_frame>At the 14th week of study participation</time_frame>
    <description>To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat mass (g)</measure>
    <time_frame>At the14th week of study participation.</time_frame>
    <description>To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein intake (g)</measure>
    <time_frame>At the 14th week of study participation.</time_frame>
    <description>To compare daily protein intake (g) assessed by 24 hour reminder, applied in interview conducted by nutritionist, of omnivorous and vegetarian participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Strength Training</condition>
  <condition>Dietary Proteins</condition>
  <condition>Muscle Strength</condition>
  <condition>Hypertrophy</condition>
  <arm_group>
    <arm_group_label>vegetarian</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals who do not consume meat (vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non vegetarian</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals who do consume meat (non vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <description>24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week</description>
    <arm_group_label>non vegetarian</arm_group_label>
    <arm_group_label>vegetarian</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Protein intake</intervention_name>
    <description>Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)</description>
    <arm_group_label>non vegetarian</arm_group_label>
    <arm_group_label>vegetarian</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be over the age of 19 and under 60;&#xD;
&#xD;
          -  Have BMI &lt;30 kg / m²;&#xD;
&#xD;
          -  Be vegetarian or omnivorous for at least 6 months;&#xD;
&#xD;
          -  Have not exercised regularly for at least 6 months.&#xD;
&#xD;
          -  Be available to practice bodybuilding at School of Physical Education, Physiotherapy&#xD;
             and Dance, 2x / week, for 3 months, free (times to combine).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Be vegan, vegetarian lacto or vegetarian egg&#xD;
&#xD;
          -  Be a carrier of chronic diseases;&#xD;
&#xD;
          -  Present physical limitations or musculoskeletal problems, which contraindicate the&#xD;
             performance of strength exercises;&#xD;
&#xD;
          -  Failure to adhere to the proposed dietary modifications, relating to the adequacy of&#xD;
             the portion of protein per meal, due to financial unfeasibility (low income&#xD;
             condition);&#xD;
&#xD;
          -  Use of protein or amino acid, caffeine or other thermogenic food supplements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolina G de Souza, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gabriela Luccciana Martini</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>October 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</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/NCT03785002
org study id: 69787617.0.0000.5327
nct id: NCT03785002
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A strength training session promotes increased muscle sensitivity to protein synthesis, which
      lasts for 24 hours after its closure. Recent studies have shown that the subsequent intake to
      the training session of approximately 20g or 0.24g / kg of high-quality protein in the same
      meal induces a plateau in this synthesis. Thus, this study aims to compare the muscular
      strength between vegetarian and omnivorous athletes with adequate protein intake to reach
      this plateau. It will recruit 64 university sportsmen who have maintained vegetarian or
      omnivorous diet for at least 6 months, totalizing 32 individuals per group. After signing the
      Term of Consent, participants will be submitted to anthropometric and body composition
      assessment (via DEXA), neuromuscular tests [(ie, muscle strength - 1RM, peak torque of knee
      extensors (JE), muscle thickness of JE and cohort analysis (ANCOVA) will be used in order to
      compare the results of the study, and to compare the results of the covariance analysis
      (ANCOVA). the levels of the neuromuscular parameters between the groups, considering the
      initial values of the force and the initial muscular thickness as covariables, the other
      parameters will be presented in the form of mean and standard deviation or median, the
      differences will be considered significant for values of p <0, 05. Expected to find no
      differences in strength and muscle thickness between vegetarians and omnivores after adequate
      protein intake.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Muscle Thickness (mm)
time frame: At the14th week of study participation.
description: To compare muscle thickness (mm) of the femoral quadriceps by Ultrasound, among vegetarian and omnivorous participants.
measure: Maximal strength (kg)
time frame: At the 14th week of study participation.
description: To compare maximal strength (kg), using the one- repetition maximum test (1RM) for bilateral knee extension exercises. Each subject's maximal load was determined with no more than five attempts and an adequate amount of recovery time was permitted between each attempt (3-5min). Each valid repetition was considered when subjects performed full knee extension with proper technique.
measure: Isometric peak torque (PTiso) (N.m)
time frame: At the 14th week of study participation.
description: To compare knee extensors Isometric peak torque (N.m), defined as the highest value of the torque recorded during unilateral knee extension, using an isokinetic dynamometer, among vegetarian and omnivorous participants.
measure: Body fat free mass (g)
time frame: At the 14th week of study participation
description: To compare body fat free mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
measure: Body fat mass (g)
time frame: At the14th week of study participation.
description: To compare body fat mass by Dual-energy x-ray absorptiometry (DEXA) evaluation, of omnivorous and vegetarian participants.
measure: Protein intake (g)
time frame: At the 14th week of study participation.
description: To compare daily protein intake (g) assessed by 24 hour reminder, applied in interview conducted by nutritionist, of omnivorous and vegetarian participants.
arm group label: vegetarian
arm group type: Experimental
description: Individuals who do not consume meat (vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner)
arm group label: non vegetarian
arm group type: Active Comparator
description: Individuals who do consume meat (non vegetarian dietary pattern) will undergo strength training sessions and guidance on protein intake (at least 20g for breakfast, lunch, and dinner)
intervention type: Other
intervention name: Strength training
description: 24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
arm group label: non vegetarian
arm group label: vegetarian
intervention type: Other
intervention name: Protein intake
description: Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
arm group label: non vegetarian
arm group label: vegetarian
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carolina G de Souza, PHD
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hypertrophy
sharing ipd: No