<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/NCT03028454</url>
  </required_header>
  <id_info>
    <org_study_id>934537-3</org_study_id>
    <nct_id>NCT03028454</nct_id>
  </id_info>
  <brief_title>Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running</brief_title>
  <official_title>Effects of Ginger on Muscle Soreness and Dysfunction Stemming From Downhill Running</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Old Dominion University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Old Dominion University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine whether five days of ginger (Zingiber officinale)&#xD;
      supplementation is effective at reducing muscle soreness and improving muscle function&#xD;
      following downhill running. Long-distance running is often associated with acute muscle pain,&#xD;
      swelling, and reduced muscle functioning, and consequently, many runners utilize&#xD;
      non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal&#xD;
      side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and&#xD;
      symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is&#xD;
      Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from&#xD;
      osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is&#xD;
      effective at reducing general pain and muscle soreness. Therefore, this study will supplement&#xD;
      60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day&#xD;
      of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and&#xD;
      function before and after the downhill run.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle Soreness Change</measure>
    <time_frame>Two days before a 40-minute downhill run, the day of a 40-minute downhill run, 24 hours after a 40-minute downhill run and the two days after a 40-minute downhill run</time_frame>
    <description>Participants will be asked to mark a slash on a 100 mm line the muscle soreness of their lower extremities, with descriptors of &quot;no soreness'' indicated at 0 and ''unbearably painful&quot; at 100. Participants will rate overall lower-extremity soreness at rest, while performing a stand-to-sit movement, and while running at a moderate pace.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Pressure Threshold Change</measure>
    <time_frame>Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run</time_frame>
    <description>An algometer will be applied to the participant's quadriceps muscle. An algometer is a handheld device with an integral load cell that transduces the pressure applied to the participant. The investigator will apply force slowly and smoothly while the participant concentrates on when the force applied by the investigator transitions from a feeling of pressure to a feeling of pain. The force level applied when the participant begins to feel pain will be considered the pain pressure threshold. The location of the measurement will be 10 cm above the superior crest of the patella. The average of two measurements will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertical Jump Test Change</measure>
    <time_frame>Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run</time_frame>
    <description>Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1.5-mile Run Change</measure>
    <time_frame>Two days before a 40-minute downhill run and two days after a 40-minute downhill run</time_frame>
    <description>Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung Function Change</measure>
    <time_frame>Two days before a 40-minute downhill run and two days after a 40-minute downhill run</time_frame>
    <description>Participants' lung function will be tested before the 1.5-mile run and at 1, 5, 10, 15, and 20 minutes post-exercise. Lung function will be assessed with a spirometer by having participants perform a maximal forced expiration. Breathing difficulty will also be measured before and after the run with the Modified Borg Dyspnea Scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Muscle Soreness</condition>
  <arm_group>
    <arm_group_label>Ginger Root Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ginger Root</intervention_name>
    <description>Capsules containing 250 mg of ginger root extract standardized to contain at least 5% gingerol compounds, as well as an additional 225 mg of regular ginger root.</description>
    <arm_group_label>Ginger Root Capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules containing rice flour powder.</description>
    <arm_group_label>Placebo Capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be currently running ≥10 miles per week&#xD;
&#xD;
          -  Have completed at least one run &gt;40 minutes over the past month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have no allergies to ginger&#xD;
&#xD;
          -  Willing to avoid pain-relieving medications for the duration of the study&#xD;
&#xD;
          -  Have no history of bleeding disorders nor currently taking blood thinners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human Performance Laboratory</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23529</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Old Dominion University</investigator_affiliation>
    <investigator_full_name>Patrick Wilson, PhD</investigator_full_name>
    <investigator_title>Assistant Professor of Exercise Science</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</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/NCT03028454
org study id: 934537-3
nct id: NCT03028454
lead sponsor: 
has dmc: No
The objective of the study is to determine whether five days of ginger (Zingiber officinale)
      supplementation is effective at reducing muscle soreness and improving muscle function
      following downhill running. Long-distance running is often associated with acute muscle pain,
      swelling, and reduced muscle functioning, and consequently, many runners utilize
      non-steroidal anti-inflammatory drugs (NSAID). NSAID use is associated with gastrointestinal
      side-effects such as stomach discomfort, nausea, dyspepsia, asymptomatic ulcers, and
      symptomatic ulcers that, although rare, can be fatal. Ginger is a botanical compound that is
      Generally Recognized as Safe by the Food and Drug Administration (FDA). Evidence from
      osteoarthritis, dysmenorrhea, and resistance-training models indicate that ginger is
      effective at reducing general pain and muscle soreness. Therefore, this study will supplement
      60 runners with roughly 1.5 g/day of ginger root or a placebo for 2 days prior to, the day
      of, and 2 days after downhill running. Participants will be evaluated for muscle soreness and
      function before and after the downhill run.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Muscle Soreness Change
time frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, 24 hours after a 40-minute downhill run and the two days after a 40-minute downhill run
description: Participants will be asked to mark a slash on a 100 mm line the muscle soreness of their lower extremities, with descriptors of "no soreness'' indicated at 0 and ''unbearably painful" at 100. Participants will rate overall lower-extremity soreness at rest, while performing a stand-to-sit movement, and while running at a moderate pace.
measure: Pain Pressure Threshold Change
time frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
description: An algometer will be applied to the participant's quadriceps muscle. An algometer is a handheld device with an integral load cell that transduces the pressure applied to the participant. The investigator will apply force slowly and smoothly while the participant concentrates on when the force applied by the investigator transitions from a feeling of pressure to a feeling of pain. The force level applied when the participant begins to feel pain will be considered the pain pressure threshold. The location of the measurement will be 10 cm above the superior crest of the patella. The average of two measurements will be taken.
measure: Vertical Jump Test Change
time frame: Two days before a 40-minute downhill run, the day of a 40-minute downhill run, and two days after a 40-minute downhill run
description: Participants will jump as high as possible using the squat jump technique. Participants will perform three trials.
measure: 1.5-mile Run Change
time frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
description: Participants will complete a maximal effort 1.5-mile run on a motorized treadmill.
measure: Lung Function Change
time frame: Two days before a 40-minute downhill run and two days after a 40-minute downhill run
description: Participants' lung function will be tested before the 1.5-mile run and at 1, 5, 10, 15, and 20 minutes post-exercise. Lung function will be assessed with a spirometer by having participants perform a maximal forced expiration. Breathing difficulty will also be measured before and after the run with the Modified Borg Dyspnea Scale.
arm group label: Ginger Root Capsule
arm group type: Experimental
arm group label: Placebo Capsule
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Ginger Root
description: Capsules containing 250 mg of ginger root extract standardized to contain at least 5% gingerol compounds, as well as an additional 225 mg of regular ginger root.
arm group label: Ginger Root Capsule
intervention type: Dietary Supplement
intervention name: Placebo
description: Capsules containing rice flour powder.
arm group label: Placebo Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Old Dominion University
investigator full name: Patrick Wilson, PhD
investigator title: Assistant Professor of Exercise Science
mesh term: Myalgia