<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/NCT03034239</url>
  </required_header>
  <id_info>
    <org_study_id>Insect2017</org_study_id>
    <nct_id>NCT03034239</nct_id>
  </id_info>
  <brief_title>The Effect of Insect Protein on Performance and Hypertrophy</brief_title>
  <official_title>The Effect of Insect Protein on Performance and Hypertrophy During Eight Weeks of Resistance Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks&#xD;
      of resistance training.&#xD;
&#xD;
      Hypothesis: Insect protein supplementation enhances the effect of resistance training on&#xD;
      muscle mass and muscle strength.&#xD;
&#xD;
      Primary outcome: Muscle hypertrophy and muscle strength&#xD;
&#xD;
      Design: Two groups of healthy young men (age: 18-30 years) with resistance training&#xD;
      experience, but no structural resistance training performed for the last 12 months.&#xD;
      Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric&#xD;
      carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming&#xD;
      to induce muscle hypertrophy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle hypertrophy</measure>
    <time_frame>8 weeks</time_frame>
    <description>muscle mass measured by DXA-scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>8 weeks</time_frame>
    <description>muscle strength measured by maximal isometric muscle strength, 1RM at bench press and leg press and 80% 1RM to fatigue in bech and leg press</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Protein Supplementation</condition>
  <arm_group>
    <arm_group_label>Insect protein group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise + insect protein 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Insect protein supplementation (4g/kg) after each training + before sleep at training days, and once in the morning at non training days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Exercise + isocaloric carbohydrate 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Carbohydrate supplementation (isocaloric to protein group) after each training + before sleep at training days, and once in the morning at non training days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein supplementation</intervention_name>
    <description>+ insect protein</description>
    <arm_group_label>Insect protein group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance training</intervention_name>
    <description>Resistance exercise</description>
    <arm_group_label>Insect protein group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy young men (age: 18-30 years) with experience in resistance training&#xD;
&#xD;
          -  2 hours of physical exercise per week or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No structural resistance training for the last 12 months&#xD;
&#xD;
          -  No injuries&#xD;
&#xD;
          -  No smoking&#xD;
&#xD;
          -  No ingesting of protein or creating supplementations&#xD;
&#xD;
          -  No use of medicine which may influence the adaptation to strength training&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Hansen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University, Department for Public Health, Section for Sport Science</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>May 8, 2017</last_update_submitted>
  <last_update_submitted_qc>May 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2017</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>
  <!-- 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/NCT03034239
org study id: Insect2017
nct id: NCT03034239
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks
      of resistance training.

      Hypothesis: Insect protein supplementation enhances the effect of resistance training on
      muscle mass and muscle strength.

      Primary outcome: Muscle hypertrophy and muscle strength

      Design: Two groups of healthy young men (age: 18-30 years) with resistance training
      experience, but no structural resistance training performed for the last 12 months.
      Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric
      carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming
      to induce muscle hypertrophy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Muscle hypertrophy
time frame: 8 weeks
description: muscle mass measured by DXA-scan
measure: Muscle Strength
time frame: 8 weeks
description: muscle strength measured by maximal isometric muscle strength, 1RM at bench press and leg press and 80% 1RM to fatigue in bech and leg press
arm group label: Insect protein group
arm group type: Experimental
description: Exercise + insect protein 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Insect protein supplementation (4g/kg) after each training + before sleep at training days, and once in the morning at non training days.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Exercise + isocaloric carbohydrate 8 weeks of 4/week progressive resistance training (2 days upper body, 2 days lower body). Carbohydrate supplementation (isocaloric to protein group) after each training + before sleep at training days, and once in the morning at non training days.
intervention type: Dietary Supplement
intervention name: Protein supplementation
description: + insect protein
arm group label: Insect protein group
intervention type: Other
intervention name: Resistance training
description: Resistance exercise
arm group label: Insect protein group
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mette Hansen, PhD
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Hypertrophy