<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/NCT04420377</url>
  </required_header>
  <id_info>
    <org_study_id>0220</org_study_id>
    <nct_id>NCT04420377</nct_id>
  </id_info>
  <brief_title>The Chronic Effects of Carnitine on Recovery</brief_title>
  <official_title>The Chronic Effects of L-Carnitine Tartrate Supplementation on Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Applied Science &amp; Performance Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lonza Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Applied Science &amp; Performance Institute</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>
      This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on&#xD;
      long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and&#xD;
      females while training two days per week. The primary outcomes defining recovery were changes&#xD;
      in serum creatine kinase levels and perceptual changes in recovery. Supporting variables&#xD;
      included an assessment of strength and power as a functional indicator of recovery. This&#xD;
      study would be the first to examine the effects of CarnipureTM on long-term recovery. Our&#xD;
      primary hypothesis was that L-carnitine supplementation would reduce muscle damage and&#xD;
      improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine&#xD;
      supplementation would better sustain strength and power and elevate SOD status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on&#xD;
      long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and&#xD;
      females while training two days per week. The primary outcomes defining recovery were changes&#xD;
      in serum creatine kinase levels and perceptual changes in recovery. Supporting variables&#xD;
      included an assessment of strength and power as a functional indicator of recovery. This&#xD;
      study would be the first to examine the effects of CarnipureTM on long-term recovery. Our&#xD;
      primary hypothesis was that L-carnitine supplementation would reduce muscle damage and&#xD;
      improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine&#xD;
      supplementation would better sustain strength and power and elevate SOD status.&#xD;
&#xD;
      In totality, the study will last 5-weeks, consisting of supplementation with maintenance&#xD;
      exercise performed 2 days per week, at home. Week 5 will consist of a pre-training&#xD;
      assessment, an intense lower-body strength endurance training day, and subsequent testing&#xD;
      48-hour testing (Post-Week 5). The baseline testing (will be performed on approximately 10&#xD;
      subjects per day over the course of 4 days) and will consist of the following measures:&#xD;
&#xD;
        -  DEXA (Dual Energy X-ray Absorptiometry) Body Composition Analysis&#xD;
&#xD;
        -  Blood Draw&#xD;
&#xD;
        -  Salivary Measures&#xD;
&#xD;
        -  Isometric Mid Thigh Pull&#xD;
&#xD;
        -  Force Plate Mechanography&#xD;
&#xD;
        -  Visual Analog Scales&#xD;
&#xD;
      For the first 4 weeks of training, participants will be asked to workout 2 days per week at&#xD;
      home.&#xD;
&#xD;
      On Monday of week five, 20 subjects will be assessed on the following measures:&#xD;
&#xD;
        -  DXA&#xD;
&#xD;
        -  Blood Draw&#xD;
&#xD;
        -  Salivary Measures&#xD;
&#xD;
        -  Isometric Mid Thigh Pull&#xD;
&#xD;
        -  Force Plate Mechanography&#xD;
&#xD;
        -  Visual Analog Scales&#xD;
&#xD;
      On Tuesday of week 5, the 20 subjects that tested on Monday, will go through an intense lower&#xD;
      body, strength endurance protocol, and the leftover 20 subjects will go through the following&#xD;
      assessments:&#xD;
&#xD;
        -  DXA&#xD;
&#xD;
        -  Blood Draw&#xD;
&#xD;
        -  Salivary Measures&#xD;
&#xD;
        -  Isometric Mid Thigh Pull&#xD;
&#xD;
        -  Force Plate Mechanography&#xD;
&#xD;
        -  Visual Analog Scales&#xD;
&#xD;
        -  Before and After the workout - Finger Prick Blood Sample&#xD;
&#xD;
      On Wednesday of week 5, the 20 subjects that tested Monday, will have a day to rest. The 20&#xD;
      subjects that tested Tuesday, will go through an intense lower body strength endurance&#xD;
      protocol.&#xD;
&#xD;
        -  Before and After the workout - Finger Prick Blood Sample (for blood lactate)&#xD;
&#xD;
      On Thursday of week 5, the 20 subjects that tested Tuesday will have the day off, while the&#xD;
      20 subjects that tested Monday will be assessed on the following measures:&#xD;
&#xD;
        -  Blood Draw&#xD;
&#xD;
        -  Salivary Measures&#xD;
&#xD;
        -  Isometric Mid Thigh Pull&#xD;
&#xD;
        -  Force Plate Mechanography&#xD;
&#xD;
        -  Visual Analog Scales&#xD;
&#xD;
      On Friday of week 5, the 20 subjects that tested Tuesday will be assessed on the following&#xD;
      measures:&#xD;
&#xD;
        -  Blood Draw&#xD;
&#xD;
        -  Salivary Measures&#xD;
&#xD;
        -  Isometric Mid Thigh Pull&#xD;
&#xD;
        -  Force Plate Mechanography&#xD;
&#xD;
        -  Visual Analog Scales&#xD;
&#xD;
      Participation will be sought from 80 male and female subjects ranging from 21 to 65 years old&#xD;
      who are active (i.e. 30 minutes per week of moderate activity classified as greater than 50 %&#xD;
      of their heart rate (HR) max 3 days • week-1). Two cohorts of 40 subjects will be examined in&#xD;
      the study.&#xD;
&#xD;
      The supplement will be administered as a dose of 2g of Carnipure (L-carnitine), per day for&#xD;
      the duration of the study. Placebo and treatment conditions will be administered in visually&#xD;
      identical capsules. Statistical analysis will be carried out on the entire study population&#xD;
      and on the female study population independently.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Actual">June 12, 2020</completion_date>
  <primary_completion_date type="Actual">June 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>
    <intervention_model_description>Double-blind, parallel, randomized, placebo-controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Blood Markers of Muscle Damage</measure>
    <time_frame>Baseline, Week 5, Post-Week 5</time_frame>
    <description>Experimental outcome examining blood protein concentrations in fasted whole blood samples.This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>- Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.</measure>
    <time_frame>Immediately prior to every resistance training session throughout the study.</time_frame>
    <description>Assessed through a visual analog scale numbered 0-10 with visual descriptors. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Muscle Power</measure>
    <time_frame>Baseline, Week 5, Post-Week 5</time_frame>
    <description>Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Muscle Strength</measure>
    <time_frame>Baseline, Week 5, Post-Week 5</time_frame>
    <description>Assessed by isometric mid-thigh pull. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Salivary Immunoglobulin A</measure>
    <time_frame>Baseline, Week 5, Post-Week 5</time_frame>
    <description>Experimental outcome examining the concentration of IgA in fasted saliva samples. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Body Composition</measure>
    <time_frame>Baseline, Post-Week 5</time_frame>
    <description>Body Composition will be assessed via dual-energy x-ray absorptiometry (DXA). Using this method, changes in total-, lean-, and fat-mass will be examined. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Superoxide Dismutase (SOD)</measure>
    <time_frame>Baseline, Week 5, Post-Week 5</time_frame>
    <description>Experimental outcome examining superoxide dismutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Muscle Soreness</condition>
  <condition>Muscle Damage</condition>
  <condition>Resistance Training</condition>
  <condition>Oxidative Stress</condition>
  <condition>Muscle Strength</condition>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will engage in a 5-week, whole-body, resistance training program 2 days per week will consuming a visually identical placebo (25mg hydroxypropyl methylcellulose) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. For week 5 of the study, participants will come in for 1 intense exercise training day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in a 5-week, whole-body, resistance training program 2 days per week will consuming a treatment condition (Carnipure™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. For week 5 of the study, participants will come in for 1 intense exercise training day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Carnipure</intervention_name>
    <description>Supplement contains L-carnitine tartrate.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>5 weeks of whole-body resistance training, performed 2 times per week.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Participation in at least 30 minutes of moderate activity exercise 3 times per week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body-mass index (BMI) of ≥ 30 kg/m²;&#xD;
&#xD;
          -  Cardiovascular, metabolic, endocrine, or thyroid disease&#xD;
&#xD;
          -  Smoking tobacco&#xD;
&#xD;
          -  Drinking alcohol (&gt;7 or &gt;14 drinks per week for women and men, respectively)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Hyperlipidemia&#xD;
&#xD;
          -  Hyperglycemia&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Metabolic disease&#xD;
&#xD;
          -  Type I or Type II Diabetes&#xD;
&#xD;
          -  Use of anabolic-androgenic steroids&#xD;
&#xD;
          -  Use of antioxidant supplements, NSAIDS, or nutritional supplements known to stimulate&#xD;
             recovery or muscle mass gains, heart disease, prescription medications, dietary&#xD;
             supplements that enhance muscle strength or muscle recovery&#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>The Applied Science and Performance Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ergogenic Aid</keyword>
  <keyword>Muscle Recovery</keyword>
  <keyword>Resistance Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myalgia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are no intentions of sharing IPD with other researchers.</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/NCT04420377
org study id: 0220
nct id: NCT04420377
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on
      long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and
      females while training two days per week. The primary outcomes defining recovery were changes
      in serum creatine kinase levels and perceptual changes in recovery. Supporting variables
      included an assessment of strength and power as a functional indicator of recovery. This
      study would be the first to examine the effects of CarnipureTM on long-term recovery. Our
      primary hypothesis was that L-carnitine supplementation would reduce muscle damage and
      improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine
      supplementation would better sustain strength and power and elevate SOD status.
This study investigated the effects of CarnipureTM, a high-quality L-carnitine ingredient, on
      long term (5 weeks) recovery, muscle damage, and SOD status in a population of males and
      females while training two days per week. The primary outcomes defining recovery were changes
      in serum creatine kinase levels and perceptual changes in recovery. Supporting variables
      included an assessment of strength and power as a functional indicator of recovery. This
      study would be the first to examine the effects of CarnipureTM on long-term recovery. Our
      primary hypothesis was that L-carnitine supplementation would reduce muscle damage and
      improve perceptual measures of recovery. Our secondary hypotheses were that L-carnitine
      supplementation would better sustain strength and power and elevate SOD status.

      In totality, the study will last 5-weeks, consisting of supplementation with maintenance
      exercise performed 2 days per week, at home. Week 5 will consist of a pre-training
      assessment, an intense lower-body strength endurance training day, and subsequent testing
      48-hour testing (Post-Week 5). The baseline testing (will be performed on approximately 10
      subjects per day over the course of 4 days) and will consist of the following measures:

        -  DEXA (Dual Energy X-ray Absorptiometry) Body Composition Analysis

        -  Blood Draw

        -  Salivary Measures

        -  Isometric Mid Thigh Pull

        -  Force Plate Mechanography

        -  Visual Analog Scales

      For the first 4 weeks of training, participants will be asked to workout 2 days per week at
      home.

      On Monday of week five, 20 subjects will be assessed on the following measures:

        -  DXA

        -  Blood Draw

        -  Salivary Measures

        -  Isometric Mid Thigh Pull

        -  Force Plate Mechanography

        -  Visual Analog Scales

      On Tuesday of week 5, the 20 subjects that tested on Monday, will go through an intense lower
      body, strength endurance protocol, and the leftover 20 subjects will go through the following
      assessments:

        -  DXA

        -  Blood Draw

        -  Salivary Measures

        -  Isometric Mid Thigh Pull

        -  Force Plate Mechanography

        -  Visual Analog Scales

        -  Before and After the workout - Finger Prick Blood Sample

      On Wednesday of week 5, the 20 subjects that tested Monday, will have a day to rest. The 20
      subjects that tested Tuesday, will go through an intense lower body strength endurance
      protocol.

        -  Before and After the workout - Finger Prick Blood Sample (for blood lactate)

      On Thursday of week 5, the 20 subjects that tested Tuesday will have the day off, while the
      20 subjects that tested Monday will be assessed on the following measures:

        -  Blood Draw

        -  Salivary Measures

        -  Isometric Mid Thigh Pull

        -  Force Plate Mechanography

        -  Visual Analog Scales

      On Friday of week 5, the 20 subjects that tested Tuesday will be assessed on the following
      measures:

        -  Blood Draw

        -  Salivary Measures

        -  Isometric Mid Thigh Pull

        -  Force Plate Mechanography

        -  Visual Analog Scales

      Participation will be sought from 80 male and female subjects ranging from 21 to 65 years old
      who are active (i.e. 30 minutes per week of moderate activity classified as greater than 50 %
      of their heart rate (HR) max 3 days • week-1). Two cohorts of 40 subjects will be examined in
      the study.

      The supplement will be administered as a dose of 2g of Carnipure (L-carnitine), per day for
      the duration of the study. Placebo and treatment conditions will be administered in visually
      identical capsules. Statistical analysis will be carried out on the entire study population
      and on the female study population independently.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blind, parallel, randomized, placebo-controlled trial.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Changes in Blood Markers of Muscle Damage
time frame: Baseline, Week 5, Post-Week 5
description: Experimental outcome examining blood protein concentrations in fasted whole blood samples.This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: - Changes in subjective recovery scale that is directly related to recovery and inversely related to soreness.
time frame: Immediately prior to every resistance training session throughout the study.
description: Assessed through a visual analog scale numbered 0-10 with visual descriptors. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: Changes in Muscle Power
time frame: Baseline, Week 5, Post-Week 5
description: Assessed through ground reaction forces during countermovement- and squat-jumps on a force plate. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: Changes in Muscle Strength
time frame: Baseline, Week 5, Post-Week 5
description: Assessed by isometric mid-thigh pull. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: Changes in Salivary Immunoglobulin A
time frame: Baseline, Week 5, Post-Week 5
description: Experimental outcome examining the concentration of IgA in fasted saliva samples. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: Changes in Body Composition
time frame: Baseline, Post-Week 5
description: Body Composition will be assessed via dual-energy x-ray absorptiometry (DXA). Using this method, changes in total-, lean-, and fat-mass will be examined. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
measure: Changes in Superoxide Dismutase (SOD)
time frame: Baseline, Week 5, Post-Week 5
description: Experimental outcome examining superoxide dismutase in fasted whole blood samples. This is another protective antioxidant enzyme measured from whole blood. This outcome will be analyzed for the entire study population and will be analyzed as a sub-analysis in females only.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Participants will engage in a 5-week, whole-body, resistance training program 2 days per week will consuming a visually identical placebo (25mg hydroxypropyl methylcellulose) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. For week 5 of the study, participants will come in for 1 intense exercise training day.
arm group label: Experimental Group
arm group type: Experimental
description: Participants will engage in a 5-week, whole-body, resistance training program 2 days per week will consuming a treatment condition (Carnipure™) 30 minutes prior to exercise on training days or with the first meal of the day on non-training days. For week 5 of the study, participants will come in for 1 intense exercise training day.
intervention type: Dietary Supplement
intervention name: Carnipure
description: Supplement contains L-carnitine tartrate.
arm group label: Experimental Group
intervention type: Other
intervention name: Resistance Training
description: 5 weeks of whole-body resistance training, performed 2 times per week.
arm group label: Experimental Group
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myalgia
sharing ipd: No
ipd description: There are no intentions of sharing IPD with other researchers.