<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/NCT03006861</url>
  </required_header>
  <id_info>
    <org_study_id>16-145b</org_study_id>
    <nct_id>NCT03006861</nct_id>
  </id_info>
  <brief_title>Delivra Topical Creatine Combined With Oral Creatine for Improving Muscular Power</brief_title>
  <official_title>Randomized, Double-blind, Placebo-controlled, Short Term Trial of DelivraTM Livsport Preworkout Cream With or Without Oral Creatine for Improved Power Output and Reduction of Muscle Fatigue During Resistant Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Guelph</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Prince Edward Island</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Creatine is a nutritional supplement that is often ingested to improve exercise performance.&#xD;
      The advent of a new product that is applied to the skin overlying muscle offers potential&#xD;
      benefit, if the creatine can be targeted to specific muscles. The investigators are testing a&#xD;
      novel creatine cream to determine the effects on human muscular performance. The&#xD;
      investigators are assessing whether 7 days of topical creatine application is additive to&#xD;
      orally-ingested creatine for improving muscular power (determined by knee extension).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Creatine monohydrate is a popular nutritional supplement with athletes involved in sports&#xD;
      involving strength and power. When creatine is orally ingested it combines with inorganic&#xD;
      phosphate to form phorylcreatine (PCr) in skeletal muscle . Adenosine Triphosphate (ATP) is&#xD;
      the immediate source of energy in muscle - during exercise ATP is broken down to Adenosine&#xD;
      Diphosphate (ADP) and inorganic phosphate. Duration of high-intensity exercise is limited to&#xD;
      a few seconds based on limited ATP stores in muscle. PCr acts to re-phosphorylate ADP to form&#xD;
      ATP so that muscle contraction can continue at high intensities. After creatine monohydrate&#xD;
      is ingested, high-intensity exercise capacity is increased because of the increased PCr&#xD;
      stores in muscle.&#xD;
&#xD;
      Traditionally, creatine is consumed orally as a supplement. Delivra Inc. has developed a&#xD;
      topical cream containing creatine that is designed to penetrate the skin. The study purpose&#xD;
      is to determine whether topically-applied creatine is additive with orally-ingested creatine&#xD;
      for improving muscular strength and power.&#xD;
&#xD;
      The hypothesis is that topically-applied creatine is additive with orally-ingested creatine&#xD;
      for improving muscular performance.&#xD;
&#xD;
      The study involves a double-blind placebo-controlled parallel group design. Participants&#xD;
      (n=132) will be randomized to receive either oral creatine supplementation or placebo (21&#xD;
      g/d) for 7 days. One leg of each participant will be randomized to receive topical creatine&#xD;
      (3.5 mL/d) and the opposite leg placebo for 7 days.&#xD;
&#xD;
      The baseline assessment involves measuring muscular power during 5 sets of 15 repetitions of&#xD;
      knee extension on a dynamometer, with each set separated by 1 minute rest, with each leg&#xD;
      tested separately. Additional measures include assessment of body composition and body water&#xD;
      content. Participants will then receive either oral creatine (21 g/d) or placebo for 7 days.&#xD;
      One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the&#xD;
      opposite leg placebo for 7 days. The same assessments as done at baseline will then be&#xD;
      repeated after the 7 days of creatine supplementation.&#xD;
&#xD;
      The primary outcomes are average and peak power output.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer</measure>
    <time_frame>Change from baseline to 7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body composition (percent fat)</measure>
    <time_frame>Change from baseline to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body water content</measure>
    <time_frame>Change from baseline to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer</measure>
    <time_frame>Change from baseline to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events recorded on adverse event forms</measure>
    <time_frame>Change from baseline to 7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Muscle Weakness</condition>
  <arm_group>
    <arm_group_label>Oral creatine supplementation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>21 g/d oral creatine for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral placebo supplementation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>21 g/d oral placebo for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>3.5 mL/d topical creatine</intervention_name>
    <arm_group_label>Oral creatine supplementation</arm_group_label>
    <arm_group_label>Oral placebo supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>3.5 mL/d topical placebo</intervention_name>
    <arm_group_label>Oral creatine supplementation</arm_group_label>
    <arm_group_label>Oral placebo supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>21 g/d Oral creatine</intervention_name>
    <arm_group_label>Oral creatine supplementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>21 g/d oral placebo</intervention_name>
    <arm_group_label>Oral placebo supplementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physically active and able to pass Physical Activity Readiness Questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergies to any ingredients in the cream&#xD;
&#xD;
          -  Answering &quot;yes&quot; to Physical Activity Readiness Questionnaire&#xD;
&#xD;
          -  Currently pregnant or breastfeeding,&#xD;
&#xD;
          -  Presence of significant medical disorder that would compromise the participant's&#xD;
             safety to take part in the trial (eg: cancer, immunosuppressed)&#xD;
&#xD;
          -  History of alcohol or drug abuse within the past year&#xD;
&#xD;
          -  Anyone using recreational drugs&#xD;
&#xD;
          -  Use of performance enhancing drugs or supplements within 2 months including caffeine&#xD;
             and creatine in supplement form&#xD;
&#xD;
          -  Currently using other topical agents for treatment of pain or inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Chilibeck, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jamie Burr, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Guelph</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Travis Saunders, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Prince Edward Island</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Guelph</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 2W1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Prince Edward Island</name>
      <address>
        <city>Charlottetown</city>
        <state>Prince Edward Island</state>
        <zip>C1A 4P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Saskatchewan</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 5B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>June 27, 2018</last_update_submitted>
  <last_update_submitted_qc>June 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Phil Chilibeck</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</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/NCT03006861
org study id: 16-145b
nct id: NCT03006861
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Creatine is a nutritional supplement that is often ingested to improve exercise performance.
      The advent of a new product that is applied to the skin overlying muscle offers potential
      benefit, if the creatine can be targeted to specific muscles. The investigators are testing a
      novel creatine cream to determine the effects on human muscular performance. The
      investigators are assessing whether 7 days of topical creatine application is additive to
      orally-ingested creatine for improving muscular power (determined by knee extension).
Creatine monohydrate is a popular nutritional supplement with athletes involved in sports
      involving strength and power. When creatine is orally ingested it combines with inorganic
      phosphate to form phorylcreatine (PCr) in skeletal muscle . Adenosine Triphosphate (ATP) is
      the immediate source of energy in muscle - during exercise ATP is broken down to Adenosine
      Diphosphate (ADP) and inorganic phosphate. Duration of high-intensity exercise is limited to
      a few seconds based on limited ATP stores in muscle. PCr acts to re-phosphorylate ADP to form
      ATP so that muscle contraction can continue at high intensities. After creatine monohydrate
      is ingested, high-intensity exercise capacity is increased because of the increased PCr
      stores in muscle.

      Traditionally, creatine is consumed orally as a supplement. Delivra Inc. has developed a
      topical cream containing creatine that is designed to penetrate the skin. The study purpose
      is to determine whether topically-applied creatine is additive with orally-ingested creatine
      for improving muscular strength and power.

      The hypothesis is that topically-applied creatine is additive with orally-ingested creatine
      for improving muscular performance.

      The study involves a double-blind placebo-controlled parallel group design. Participants
      (n=132) will be randomized to receive either oral creatine supplementation or placebo (21
      g/d) for 7 days. One leg of each participant will be randomized to receive topical creatine
      (3.5 mL/d) and the opposite leg placebo for 7 days.

      The baseline assessment involves measuring muscular power during 5 sets of 15 repetitions of
      knee extension on a dynamometer, with each set separated by 1 minute rest, with each leg
      tested separately. Additional measures include assessment of body composition and body water
      content. Participants will then receive either oral creatine (21 g/d) or placebo for 7 days.
      One leg of each participant will be randomized to receive topical creatine (3.5 mL/d) and the
      opposite leg placebo for 7 days. The same assessments as done at baseline will then be
      repeated after the 7 days of creatine supplementation.

      The primary outcomes are average and peak power output.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in average power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
time frame: Change from baseline to 7 days
measure: Change in body composition (percent fat)
time frame: Change from baseline to 7 days
measure: Change in body water content
time frame: Change from baseline to 7 days
measure: Change in peak power across 5 set of 15 repetitions separated by 60s rest on an isokinetic dynamometer
time frame: Change from baseline to 7 days
measure: Adverse events recorded on adverse event forms
time frame: Change from baseline to 7 days
arm group label: Oral creatine supplementation
arm group type: Experimental
description: 21 g/d oral creatine for 7 days
arm group label: Oral placebo supplementation
arm group type: Placebo Comparator
description: 21 g/d oral placebo for 7 days
intervention type: Dietary Supplement
intervention name: 3.5 mL/d topical creatine
arm group label: Oral creatine supplementation
arm group label: Oral placebo supplementation
intervention type: Dietary Supplement
intervention name: 3.5 mL/d topical placebo
arm group label: Oral creatine supplementation
arm group label: Oral placebo supplementation
intervention type: Dietary Supplement
intervention name: 21 g/d Oral creatine
arm group label: Oral creatine supplementation
intervention type: Dietary Supplement
intervention name: 21 g/d oral placebo
arm group label: Oral placebo supplementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Chilibeck, PhD
role: Principal Investigator
affiliation: University of Saskatchewan
last name: Jamie Burr, PhD
role: Principal Investigator
affiliation: University of Guelph
last name: Travis Saunders, PhD
role: Principal Investigator
affiliation: University of Prince Edward Island
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Phil Chilibeck
investigator title: Professor
mesh term: Muscle Weakness
sharing ipd: No