<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/NCT03295968</url>
  </required_header>
  <id_info>
    <org_study_id>REB32277</org_study_id>
    <nct_id>NCT03295968</nct_id>
  </id_info>
  <brief_title>IL-6 in Exercise-Induced Anorexia</brief_title>
  <official_title>The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effect of high intensity exercise, with and without the&#xD;
      inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of&#xD;
      inflammation and appetite on food intake and subjective ratings of appetite in normal-weight&#xD;
      boys.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>
    <intervention_model_description>Fifteen normal-weight boys (aged 13-18y) were randomly assigned in a crossover design to four sessions: 1) Water + Rest; 2) Rest + ibuprofen; 3) Water + high intensity exercise; 4) high intensity exercise + ibuprofen. High intensity exercise consisted of three 10min bouts of high intensity exercise at 75% VO2peak at 60-70RPM with 1:30min active rest interposed. IBU was given in a 300mg liquid solution. EI, visual analog scale ratings and plasma biomarkers of appetite, inflammation, stress and glucose control were measured.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Water control and ibuprofen solution contained 0.8 g of Sucralose (Heartland Food Products Group, Amsterdam, HP, Netherlands) and 1.2 g of orange flavored Kool-Aid (Kraft Foods, Northfield, IL, United States) to mask the taste of the Motrin solution. To match sweetness and calorie content of the ibuprofen Motrin drink, the water control also contained 6 mL high fructose corn syrup (ACH Food Companies, Mississauga, ON, Canada).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Food Intake</measure>
    <time_frame>100-120 min</time_frame>
    <description>Participants were provided with ad libitum lunch meal, consisting of rice (Uncle Ben's, Bolton, ON, Canada), beef meatballs (President's Choice, Brampton, ON, Canada) and tomato sauce (Ragu, Mount Prospect, IL, USA) at 100 - 120 min. The meatballs were cut into small and uniform pieces and were mixed homogeneously with the other ingredients in a bowl. One bowl was a 479.5 g portion which represented 827.5 kcal, 30.8 g fat, 104.8 g carbohydrate and 30.2 g protein based on the weight consumed and the compositional information provided by the manufacturers. Two portions we served in 10 min intervals and FI from the pizza meal was calculated based on the weight consumed during the lunch. Participants were instructed to eat until comfortably and stay seated during the duration of the meal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale Appetite Scores</measure>
    <time_frame>0-120min</time_frame>
    <description>Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appetite Biomarkers</measure>
    <time_frame>0-120min</time_frame>
    <description>Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inflammatory and Stress Biomarkers</measure>
    <time_frame>0-120min</time_frame>
    <description>Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Appetitive Behavior</condition>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Water and Rest</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Water and High Intensity Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen and Rest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ibuprofen and High Intensity Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Intensity Exercise/Ibuprofen</intervention_name>
    <description>HIEX, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.</description>
    <arm_group_label>Ibuprofen and High Intensity Exercise</arm_group_label>
    <arm_group_label>Ibuprofen and Rest</arm_group_label>
    <arm_group_label>Water and High Intensity Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-18 yrs, healthy, male&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic&#xD;
             diseases, scoring ≥11 on an Eating Habit Questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Fifteen normal-weight (BMI for age percentile: 15th-85th) boys aged 13-18yrs completed the study. Sample size was determined through previous studies in our lab. A telephone questionnaire was employed to determine eligibility for this study. Boys who answered &quot;yes&quot; to one of the questions of the physical activity readiness questionnaire, displayed a form of heamatophobia, dieters, have been diagnosed with diabetes or other metabolic diseases, and those scoring ≥11 on an Eating Habit Questionnaire were excluded from the study.</gender_description>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Toronto</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 3E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Almada C, Cataldo LR, Smalley SV, Diaz E, Serrano A, Hodgson MI, Santos JL. Plasma levels of interleukin-6 and interleukin-18 after an acute physical exercise: relation with post-exercise energy intake in twins. J Physiol Biochem. 2013 Mar;69(1):85-95. doi: 10.1007/s13105-012-0191-x. Epub 2012 Jul 19.</citation>
    <PMID>22810957</PMID>
  </reference>
  <reference>
    <citation>Anderson GH, Hunschede S, Akilen R, Kubant R. Physiology of Food Intake Control in Children. Adv Nutr. 2016 Jan 15;7(1):232S-240S. doi: 10.3945/an.115.009357. Print 2016 Jan.</citation>
    <PMID>26773031</PMID>
  </reference>
  <reference>
    <citation>Banks WA. Anorectic effects of circulating cytokines: role of the vascular blood-brain barrier. Nutrition. 2001 May;17(5):434-7. doi: 10.1016/s0899-9007(01)00507-x.</citation>
    <PMID>11377145</PMID>
  </reference>
  <reference>
    <citation>Banks WA, Gertler A, Solomon G, Niv-Spector L, Shpilman M, Yi X, Batrakova E, Vinogradov S, Kabanov AV. Principles of strategic drug delivery to the brain (SDDB): development of anorectic and orexigenic analogs of leptin. Physiol Behav. 2011 Nov 30;105(1):145-9. doi: 10.1016/j.physbeh.2011.05.024. Epub 2011 Jun 6.</citation>
    <PMID>21669216</PMID>
  </reference>
  <reference>
    <citation>Blundell JE, Gibbons C, Caudwell P, Finlayson G, Hopkins M. Appetite control and energy balance: impact of exercise. Obes Rev. 2015 Feb;16 Suppl 1:67-76. doi: 10.1111/obr.12257.</citation>
    <PMID>25614205</PMID>
  </reference>
  <reference>
    <citation>Blundell JE, King NA. Exercise, appetite control, and energy balance. Nutrition. 2000 Jul-Aug;16(7-8):519-22. doi: 10.1016/s0899-9007(00)00250-1. No abstract available.</citation>
    <PMID>10906542</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>G. Harvey Anderson</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>Pediatric Obesity</mesh_term>
    <mesh_term>Anorexia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be made available to other researchers.Participant's identities will be kept confidential. Records will be kept in a locked filing cabinet in the Fitzgerald building at 150 College Street, room 437. Access will be restricted to those directly involved with the project, such as the investigator and the co-investigators. Following recruitment and attainment of informed consent, participants will be given an ID # which will be used on all forms and data analysis. Informed consent forms will be kept in a locked cabinet in a locked office, contain participant names. Research records will be identified by initials, ID number, test and date. Results identified by date and ID number will only be entered on password-protected personal computers kept in locked laboratories or offices at the University of Toronto. Any electronic data will be held on encrypted computers and USB sticks for the same period of time.</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/NCT03295968
org study id: REB32277
nct id: NCT03295968
lead sponsor: 
has dmc: No
This study investigates the effect of high intensity exercise, with and without the
      inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of
      inflammation and appetite on food intake and subjective ratings of appetite in normal-weight
      boys.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Fifteen normal-weight boys (aged 13-18y) were randomly assigned in a crossover design to four sessions: 1) Water + Rest; 2) Rest + ibuprofen; 3) Water + high intensity exercise; 4) high intensity exercise + ibuprofen. High intensity exercise consisted of three 10min bouts of high intensity exercise at 75% VO2peak at 60-70RPM with 1:30min active rest interposed. IBU was given in a 300mg liquid solution. EI, visual analog scale ratings and plasma biomarkers of appetite, inflammation, stress and glucose control were measured.
primary purpose: Basic Science
masking: Single (Participant)
masking description: Water control and ibuprofen solution contained 0.8 g of Sucralose (Heartland Food Products Group, Amsterdam, HP, Netherlands) and 1.2 g of orange flavored Kool-Aid (Kraft Foods, Northfield, IL, United States) to mask the taste of the Motrin solution. To match sweetness and calorie content of the ibuprofen Motrin drink, the water control also contained 6 mL high fructose corn syrup (ACH Food Companies, Mississauga, ON, Canada).
measure: Food Intake
time frame: 100-120 min
description: Participants were provided with ad libitum lunch meal, consisting of rice (Uncle Ben's, Bolton, ON, Canada), beef meatballs (President's Choice, Brampton, ON, Canada) and tomato sauce (Ragu, Mount Prospect, IL, USA) at 100 - 120 min. The meatballs were cut into small and uniform pieces and were mixed homogeneously with the other ingredients in a bowl. One bowl was a 479.5 g portion which represented 827.5 kcal, 30.8 g fat, 104.8 g carbohydrate and 30.2 g protein based on the weight consumed and the compositional information provided by the manufacturers. Two portions we served in 10 min intervals and FI from the pizza meal was calculated based on the weight consumed during the lunch. Participants were instructed to eat until comfortably and stay seated during the duration of the meal.
measure: Visual Analog Scale Appetite Scores
time frame: 0-120min
description: Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.
measure: Appetite Biomarkers
time frame: 0-120min
description: Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
measure: Inflammatory and Stress Biomarkers
time frame: 0-120min
description: Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.
arm group label: Water and Rest
arm group type: No Intervention
arm group label: Water and High Intensity Exercise
arm group type: Experimental
arm group label: Ibuprofen and Rest
arm group type: Experimental
arm group label: Ibuprofen and High Intensity Exercise
arm group type: Experimental
intervention type: Other
intervention name: High Intensity Exercise/Ibuprofen
description: HIEX, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.
arm group label: Ibuprofen and High Intensity Exercise
arm group label: Ibuprofen and Rest
arm group label: Water and High Intensity Exercise
criteria: 
gender: Male
gender based: Yes
gender description: Fifteen normal-weight (BMI for age percentile: 15th-85th) boys aged 13-18yrs completed the study. Sample size was determined through previous studies in our lab. A telephone questionnaire was employed to determine eligibility for this study. Boys who answered "yes" to one of the questions of the physical activity readiness questionnaire, displayed a form of heamatophobia, dieters, have been diagnosed with diabetes or other metabolic diseases, and those scoring ≥11 on an Eating Habit Questionnaire were excluded from the study.
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
citation: Almada C, Cataldo LR, Smalley SV, Diaz E, Serrano A, Hodgson MI, Santos JL. Plasma levels of interleukin-6 and interleukin-18 after an acute physical exercise: relation with post-exercise energy intake in twins. J Physiol Biochem. 2013 Mar;69(1):85-95. doi: 10.1007/s13105-012-0191-x. Epub 2012 Jul 19.
PMID: 22810957
citation: Anderson GH, Hunschede S, Akilen R, Kubant R. Physiology of Food Intake Control in Children. Adv Nutr. 2016 Jan 15;7(1):232S-240S. doi: 10.3945/an.115.009357. Print 2016 Jan.
PMID: 26773031
citation: Banks WA. Anorectic effects of circulating cytokines: role of the vascular blood-brain barrier. Nutrition. 2001 May;17(5):434-7. doi: 10.1016/s0899-9007(01)00507-x.
PMID: 11377145
citation: Banks WA, Gertler A, Solomon G, Niv-Spector L, Shpilman M, Yi X, Batrakova E, Vinogradov S, Kabanov AV. Principles of strategic drug delivery to the brain (SDDB): development of anorectic and orexigenic analogs of leptin. Physiol Behav. 2011 Nov 30;105(1):145-9. doi: 10.1016/j.physbeh.2011.05.024. Epub 2011 Jun 6.
PMID: 21669216
citation: Blundell JE, Gibbons C, Caudwell P, Finlayson G, Hopkins M. Appetite control and energy balance: impact of exercise. Obes Rev. 2015 Feb;16 Suppl 1:67-76. doi: 10.1111/obr.12257.
PMID: 25614205
citation: Blundell JE, King NA. Exercise, appetite control, and energy balance. Nutrition. 2000 Jul-Aug;16(7-8):519-22. doi: 10.1016/s0899-9007(00)00250-1. No abstract available.
PMID: 10906542
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: G. Harvey Anderson
investigator title: Professor
mesh term: Pediatric Obesity
mesh term: Anorexia
mesh term: Ibuprofen
sharing ipd: No
ipd description: Individual participant data will not be made available to other researchers.Participant's identities will be kept confidential. Records will be kept in a locked filing cabinet in the Fitzgerald building at 150 College Street, room 437. Access will be restricted to those directly involved with the project, such as the investigator and the co-investigators. Following recruitment and attainment of informed consent, participants will be given an ID # which will be used on all forms and data analysis. Informed consent forms will be kept in a locked cabinet in a locked office, contain participant names. Research records will be identified by initials, ID number, test and date. Results identified by date and ID number will only be entered on password-protected personal computers kept in locked laboratories or offices at the University of Toronto. Any electronic data will be held on encrypted computers and USB sticks for the same period of time.