<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/NCT02980900</url>
  </required_header>
  <id_info>
    <org_study_id>181739</org_study_id>
    <nct_id>NCT02980900</nct_id>
  </id_info>
  <brief_title>The Effect of Protein Ingestion on the Recovery of Skeletal Muscle Function Following Eccentric Exercise.</brief_title>
  <acronym>SPADE</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</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 present study will assess the effect of the type and timing of protein ingestion 6 days&#xD;
      prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of&#xD;
      muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Isokinetic force production of the knee extensor muscles</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle protein synthesis</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh volume</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived muscle soreness</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric force production of the knee extensor muscles</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Post exercise placebo supplement Pre bed placebo supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post exercise supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post exercise protein-polyphenol supplement Pre bed placebo supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre bed supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post exercise placebo supplement Pre bed protein-polyphenol supplement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post exercise + pre bed supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post exercise protein-polyphenol supplement Pre bed protein-polyphenol supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Post exercise protein-polyphenol supplement</intervention_name>
    <description>Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.</description>
    <arm_group_label>Post exercise + pre bed supplement</arm_group_label>
    <arm_group_label>Post exercise supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Post exercise placebo supplement</intervention_name>
    <description>Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.</description>
    <arm_group_label>Placebo supplement</arm_group_label>
    <arm_group_label>Pre bed supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pre bed protein-polyphenol supplement</intervention_name>
    <description>Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.</description>
    <arm_group_label>Post exercise + pre bed supplement</arm_group_label>
    <arm_group_label>Pre bed supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pre bed placebo supplement</intervention_name>
    <description>Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.</description>
    <arm_group_label>Placebo supplement</arm_group_label>
    <arm_group_label>Post exercise supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women who are generally healthy and recreationally active&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active cardiovascular disease or hypertension&#xD;
&#xD;
          -  Diagnosed metabolic impairment&#xD;
&#xD;
          -  Use of nutritional supplements&#xD;
&#xD;
          -  Use of anti-inflammatory medications&#xD;
&#xD;
          -  Habitual dietary protein intake of &lt;0.8g/kg/day&#xD;
&#xD;
          -  Musculoskeletal disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sport and Health Sciences</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02980900
org study id: 181739
nct id: NCT02980900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study will assess the effect of the type and timing of protein ingestion 6 days
      prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of
      muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Isokinetic force production of the knee extensor muscles
time frame: 14 days
measure: Muscle protein synthesis
time frame: 14 days
measure: Thigh volume
time frame: 14 days
measure: Perceived muscle soreness
time frame: 14 days
measure: Isometric force production of the knee extensor muscles
time frame: 14 days
arm group label: Placebo supplement
arm group type: Placebo Comparator
description: Post exercise placebo supplement Pre bed placebo supplement
arm group label: Post exercise supplement
arm group type: Active Comparator
description: Post exercise protein-polyphenol supplement Pre bed placebo supplement
arm group label: Pre bed supplement
arm group type: Active Comparator
description: Post exercise placebo supplement Pre bed protein-polyphenol supplement
arm group label: Post exercise + pre bed supplement
arm group type: Active Comparator
description: Post exercise protein-polyphenol supplement Pre bed protein-polyphenol supplement
intervention type: Dietary Supplement
intervention name: Post exercise protein-polyphenol supplement
description: Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
arm group label: Post exercise + pre bed supplement
arm group label: Post exercise supplement
intervention type: Dietary Supplement
intervention name: Post exercise placebo supplement
description: Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
arm group label: Placebo supplement
arm group label: Pre bed supplement
intervention type: Dietary Supplement
intervention name: Pre bed protein-polyphenol supplement
description: Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
arm group label: Post exercise + pre bed supplement
arm group label: Pre bed supplement
intervention type: Dietary Supplement
intervention name: Pre bed placebo supplement
description: Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
arm group label: Placebo supplement
arm group label: Post exercise supplement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No