<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/NCT04411173</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-19-L0043</org_study_id>
    <nct_id>NCT04411173</nct_id>
  </id_info>
  <brief_title>Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations</brief_title>
  <official_title>Effect of Daily Doses of Rice or Whey Protein on Resistance Training Adaptations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lindenwood University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lindenwood University</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>
      The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x&#xD;
      15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations&#xD;
      in young, healthy, resistance-trained men.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted using a randomized, double-blind approach with individuals being&#xD;
      provided two doses of either 15 grams of rice or 15 grams of whey protein over an 8-week&#xD;
      supplementation period while completing a heavy resistance training. One dose will be&#xD;
      ingested within one hour of completing each workout and the other dose will be ingested&#xD;
      within an hour of going to bed. On non-workout days, one dose of 30 grams will be ingested&#xD;
      within 60 minutes of going to bed. The resistance training protocol will follow a linear&#xD;
      periodization, split-body resistance training design consisting of two upper body and two&#xD;
      lower body workouts each week resulting in each muscle group being trained twice each week.&#xD;
      To minimize the influence of training experience and any learning effect, individuals with at&#xD;
      least 12 months of resistance training history will be recruited. Participants will also be&#xD;
      required to complete a two-week lead-in period (8 total workouts) before beginning the&#xD;
      supplementation regimen to become accustomed to the training program and to account for any&#xD;
      early neurological adaptations. Participants will then continue to follow the resistance&#xD;
      training program for an additional 8 weeks. To assess the efficacy of the two different forms&#xD;
      of protein supplementation on resistance training adaptations, changes in fat-free, lean, and&#xD;
      fat mass will be determined using DEXA. Maximal strength and endurance of both upper and&#xD;
      lower-body muscle groups will be determined while anaerobic capacity markers will be measured&#xD;
      with the completion of a Wingate anaerobic capacity test. Participants will also be provided&#xD;
      nutritional recommendations in order to ensure adequate energy and macronutrient consumption&#xD;
      to facilitate positive training adaptations and eliminate any potential influence of&#xD;
      differing dietary intakes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2018</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The supplements were delivered in identical containers with rather an &quot;A&quot; or &quot;B&quot; marked on the outside of the bag. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in upper- and lower-body strength via Dual-Energy X-ray Absorptiometry</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Examining how much strength each participant gains (or loses) from Day 1 to Final day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in fat-free mass via Dual-Energy X-ray Absorptiometry</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Examining the differences in fat-free mass from Day 1 to Final day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in muscular endurance by counting repetitions for each exercise test</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Examining the differences in muscular endurance from Day 1 to Final day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resistance training volume by tracking how many pounds were lifted during each exercise</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Examining the differences in resistance training volume from Day 1 to Final day</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertrophy</condition>
  <arm_group>
    <arm_group_label>Rice Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rice Protein - 24 grams, chocolate, powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whey Protein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Whey Protein - 24 grams, chocolate, powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Whey Protein</intervention_name>
    <description>Each condition (both rice and whey protein) match in color, flavor, and serving size.</description>
    <arm_group_label>Rice Protein</arm_group_label>
    <arm_group_label>Whey Protein</arm_group_label>
    <other_name>Rice Protein</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18-50 years, although it is anticipated that the majority of&#xD;
             participants will be between 18 and 35 years of age.&#xD;
&#xD;
          -  Participants will be healthy and free of disease as determined by evaluation of a&#xD;
             medical history&#xD;
&#xD;
          -  All participants will be required to abstain from taking any additional forms of&#xD;
             nutritional supplementation (preworkouts, creatine, beta-alanine, etc.) for four weeks&#xD;
             prior to beginning this study and for the entire duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those individuals with less than 12 months of structured resistance training&#xD;
             experience will be excluded from the study.&#xD;
&#xD;
          -  Individuals whose maximal relative upper body strength is below 1.0 will be excluded.&#xD;
&#xD;
          -  Individuals whose maximal relative lower body strength is below 1.50 will be excluded.&#xD;
&#xD;
          -  As indicated on a medical history form they complete, any individual who is currently&#xD;
             being treated for or diagnosed with a cardiac, respiratory, circulatory,&#xD;
             musculoskeletal, metabolic, obesity (defined as body mass index &gt; 30 kg/m2 and body&#xD;
             fat greater than 30%), immune, autoimmune, psychiatric, hematological, neurological or&#xD;
             endocrinological disorder or disease will be excluded.&#xD;
&#xD;
          -  Those individuals who present with any previous injury or illness that would prevent&#xD;
             them from appropriately completing all exercise lifts will be excluded from the study.&#xD;
&#xD;
          -  Participants who are not able to fit onto the DEXA table will not be able to&#xD;
             participate in the research due to size restrictions of the equipment. This typically&#xD;
             includes individuals exceeding 300 pounds or those greater than 6 feet 6 inches.&#xD;
&#xD;
          -  Those individuals less than 18 and greater than 50 years of age will be excluded.&#xD;
             Participants younger than 18 are excluded due to necessity of parental consent.&#xD;
             Participants greater than 50 years old lie outside of the target demographic for the&#xD;
             current study.&#xD;
&#xD;
          -  Participants who are determined to not be weight stable defined as week 0 and week 2&#xD;
             body mass levels deviating by 2% or more.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chad Kerksice, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laboratory Director</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lindenwood University</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 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>
    <ipd_description>All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.</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/NCT04411173
org study id: IRB-19-L0043
nct id: NCT04411173
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the ability of isocaloric and isonitrogenous (2 x
      15-gram) doses of rice protein or whey protein to stimulate resistance training adaptations
      in young, healthy, resistance-trained men.
The study will be conducted using a randomized, double-blind approach with individuals being
      provided two doses of either 15 grams of rice or 15 grams of whey protein over an 8-week
      supplementation period while completing a heavy resistance training. One dose will be
      ingested within one hour of completing each workout and the other dose will be ingested
      within an hour of going to bed. On non-workout days, one dose of 30 grams will be ingested
      within 60 minutes of going to bed. The resistance training protocol will follow a linear
      periodization, split-body resistance training design consisting of two upper body and two
      lower body workouts each week resulting in each muscle group being trained twice each week.
      To minimize the influence of training experience and any learning effect, individuals with at
      least 12 months of resistance training history will be recruited. Participants will also be
      required to complete a two-week lead-in period (8 total workouts) before beginning the
      supplementation regimen to become accustomed to the training program and to account for any
      early neurological adaptations. Participants will then continue to follow the resistance
      training program for an additional 8 weeks. To assess the efficacy of the two different forms
      of protein supplementation on resistance training adaptations, changes in fat-free, lean, and
      fat mass will be determined using DEXA. Maximal strength and endurance of both upper and
      lower-body muscle groups will be determined while anaerobic capacity markers will be measured
      with the completion of a Wingate anaerobic capacity test. Participants will also be provided
      nutritional recommendations in order to ensure adequate energy and macronutrient consumption
      to facilitate positive training adaptations and eliminate any potential influence of
      differing dietary intakes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: The supplements were delivered in identical containers with rather an "A" or "B" marked on the outside of the bag. Once data collection, data entry, and statistical analysis was completely finished, the study code was broken.
measure: Changes in upper- and lower-body strength via Dual-Energy X-ray Absorptiometry
time frame: Eight weeks
description: Examining how much strength each participant gains (or loses) from Day 1 to Final day
measure: Changes in fat-free mass via Dual-Energy X-ray Absorptiometry
time frame: Eight weeks
description: Examining the differences in fat-free mass from Day 1 to Final day
measure: Changes in muscular endurance by counting repetitions for each exercise test
time frame: Eight weeks
description: Examining the differences in muscular endurance from Day 1 to Final day
measure: Changes in resistance training volume by tracking how many pounds were lifted during each exercise
time frame: Eight weeks
description: Examining the differences in resistance training volume from Day 1 to Final day
arm group label: Rice Protein
arm group type: Active Comparator
description: Rice Protein - 24 grams, chocolate, powder
arm group label: Whey Protein
arm group type: Active Comparator
description: Whey Protein - 24 grams, chocolate, powder
intervention type: Dietary Supplement
intervention name: Whey Protein
description: Each condition (both rice and whey protein) match in color, flavor, and serving size.
arm group label: Rice Protein
arm group label: Whey Protein
other name: Rice Protein
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chad Kerksice, PhD
role: Study Director
affiliation: Laboratory Director
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertrophy
sharing ipd: No
ipd description: All approved unidentified study data inside the laboratory will be saved within a research repository bank for future research questions. Otherwise, participant data will be destroyed after three years of study completion to maintain IRB compliance.