<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/NCT03811717</url>
  </required_header>
  <id_info>
    <org_study_id>QMPL_HI-01-19</org_study_id>
    <nct_id>NCT03811717</nct_id>
  </id_info>
  <brief_title>Fasting and Exercise-induced Changes in Human Skeletal Muscle</brief_title>
  <official_title>Impact of Exercise-induced Energetic Stress During an 8-hour Fast on Metabolic Regulation in Resting Human Skeletal Muscle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University</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 examines the impact of increasing energetic stress during an 8-hour fast on&#xD;
      metabolic pathways in human skeletal muscle. Specifically, participants will undergo two&#xD;
      8-hour fasting sessions in a randomized crossover fashion, with the addition of low-intensity&#xD;
      arm exercise in one of the sessions. Changes in metabolic pathways will be examined in&#xD;
      resting (leg) muscle before, during, and after the fast.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Allocation concealment, assessor blinding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Peroxisome proliferator activated receptor gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>PGC-1α gene expression (indirect indicator of PGC-1α activity)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Catecholamine concentrations</measure>
    <time_frame>15 min before fast; after exercise; after 4 and 8 hours of fasting</time_frame>
    <description>Epinephrine and norepinephrine concentrations in plasma samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose and insulin concentrations</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>Glucose and insulin concentrations in plasma samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated AMP activated protein kinase (AMPK)</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active AMPK relative to total AMPK protein content</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated SIRT-1</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active SIRT-1 relative to total SIRT1 protein content</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated mammalian target of rapamycin (mTOR)</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active mTOR relative to total mTOR protein content</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated Akt/Protein Kinase B</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active Akt relative to total Akt protein content</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated acetyl coenzyme A carboxylase (ACC)</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active ACC relative to total ACC protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total and phosphorylated p38 mitogen activated protein kinase (MAPK)</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>active p38 MAPK relative to total p38 MAPK protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>phosphorylated protein kinase A (PKA) substrates</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>phosphorylated PKA substrates (indirect measure of PKA activity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acetylated p53</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>p53 acetylation status (indirect measure of SIRT-1 deacetylase activity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sirtuin 1 (SIRT1) mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of the deacetylase enzyme SIRT1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sirtuin 3 (SIRT3) mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of the deacetylase enzyme SIRT3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pyruvate dehydrogenase kinase isoenzyme 4 (PDK4) mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of the PGC-1α target PDK4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>p53 mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of the tumour suppressor protein p53</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leucine rich pentatricopeptide repeat containing protein (LRP130) mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of RNA-binding protein LRP130</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General control non-repressible 5 (GCN5) mRNA expression</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>gene expression of the acetyltransferase GCN5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGC-1α protein content</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>Protein content of the transcriptional co-activator PGC-1α</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytochrome C oxidase subunit 4 (COX-IV) protein content</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>Protein content of the mitochondrial enzyme COX subunit 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intramuscular glycogen content</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>Muscle glycogen content</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intramuscular triglyceride (IMTG) content</measure>
    <time_frame>15 min before fast; after 4 and 8 hours of fasting</time_frame>
    <description>Muscle IMTG content</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Skeletal Muscle Energetics</condition>
  <arm_group>
    <arm_group_label>FAST+EX - FAST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FAST+EX then FAST alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAST - FAST+EX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FAST alone then FAST+EX</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FAST+EX</intervention_name>
    <description>Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.</description>
    <arm_group_label>FAST - FAST+EX</arm_group_label>
    <arm_group_label>FAST+EX - FAST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FAST</intervention_name>
    <description>Participants will complete an 8-hour fast.</description>
    <arm_group_label>FAST - FAST+EX</arm_group_label>
    <arm_group_label>FAST+EX - FAST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  recreationally active (no more than 3 hours of weekly physical activity)&#xD;
&#xD;
          -  not currently involved in a systematic training program&#xD;
&#xD;
          -  body mass index &lt; 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of cardiometabolic disease&#xD;
&#xD;
          -  taking regular oral medication&#xD;
&#xD;
          -  current smoker&#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>Brendon J. Gurd, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Kinesiology and Health Studies</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L3N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Brendon Gurd</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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/NCT03811717
org study id: QMPL_HI-01-19
nct id: NCT03811717
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the impact of increasing energetic stress during an 8-hour fast on
      metabolic pathways in human skeletal muscle. Specifically, participants will undergo two
      8-hour fasting sessions in a randomized crossover fashion, with the addition of low-intensity
      arm exercise in one of the sessions. Changes in metabolic pathways will be examined in
      resting (leg) muscle before, during, and after the fast.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: Allocation concealment, assessor blinding
measure: Peroxisome proliferator activated receptor gamma co-activator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA) expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: PGC-1α gene expression (indirect indicator of PGC-1α activity)
measure: Catecholamine concentrations
time frame: 15 min before fast; after exercise; after 4 and 8 hours of fasting
description: Epinephrine and norepinephrine concentrations in plasma samples
measure: Glucose and insulin concentrations
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: Glucose and insulin concentrations in plasma samples
measure: total and phosphorylated AMP activated protein kinase (AMPK)
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active AMPK relative to total AMPK protein content
measure: total and phosphorylated SIRT-1
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active SIRT-1 relative to total SIRT1 protein content
measure: total and phosphorylated mammalian target of rapamycin (mTOR)
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active mTOR relative to total mTOR protein content
measure: total and phosphorylated Akt/Protein Kinase B
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active Akt relative to total Akt protein content
measure: total and phosphorylated acetyl coenzyme A carboxylase (ACC)
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active ACC relative to total ACC protein
measure: total and phosphorylated p38 mitogen activated protein kinase (MAPK)
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: active p38 MAPK relative to total p38 MAPK protein
measure: phosphorylated protein kinase A (PKA) substrates
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: phosphorylated PKA substrates (indirect measure of PKA activity)
measure: acetylated p53
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: p53 acetylation status (indirect measure of SIRT-1 deacetylase activity)
measure: Sirtuin 1 (SIRT1) mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of the deacetylase enzyme SIRT1
measure: Sirtuin 3 (SIRT3) mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of the deacetylase enzyme SIRT3
measure: Pyruvate dehydrogenase kinase isoenzyme 4 (PDK4) mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of the PGC-1α target PDK4
measure: p53 mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of the tumour suppressor protein p53
measure: Leucine rich pentatricopeptide repeat containing protein (LRP130) mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of RNA-binding protein LRP130
measure: General control non-repressible 5 (GCN5) mRNA expression
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: gene expression of the acetyltransferase GCN5
measure: PGC-1α protein content
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: Protein content of the transcriptional co-activator PGC-1α
measure: Cytochrome C oxidase subunit 4 (COX-IV) protein content
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: Protein content of the mitochondrial enzyme COX subunit 4
measure: Intramuscular glycogen content
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: Muscle glycogen content
measure: Intramuscular triglyceride (IMTG) content
time frame: 15 min before fast; after 4 and 8 hours of fasting
description: Muscle IMTG content
arm group label: FAST+EX - FAST
arm group type: Experimental
description: FAST+EX then FAST alone
arm group label: FAST - FAST+EX
arm group type: Experimental
description: FAST alone then FAST+EX
intervention type: Other
intervention name: FAST+EX
description: Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.
arm group label: FAST - FAST+EX
arm group label: FAST+EX - FAST
intervention type: Other
intervention name: FAST
description: Participants will complete an 8-hour fast.
arm group label: FAST - FAST+EX
arm group label: FAST+EX - FAST
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brendon J. Gurd, PhD
role: Principal Investigator
affiliation: Queen's University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Brendon Gurd
investigator title: Associate Professor
sharing ipd: No