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IL-6 in Exercise-Induced Anorexia

Primary Purpose

Appetitive Behavior, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Exercise/Ibuprofen
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Appetitive Behavior

Eligibility Criteria

13 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 13-18 yrs, healthy, male

Exclusion Criteria:

  • female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire

Sites / Locations

  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Water and Rest

Water and High Intensity Exercise

Ibuprofen and Rest

Ibuprofen and High Intensity Exercise

Arm Description

Outcomes

Primary Outcome Measures

Food Intake
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.
Visual Analog Scale Appetite Scores
Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.
Appetite Biomarkers
Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
Inflammatory and Stress Biomarkers
Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2017
Last Updated
September 27, 2017
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03295968
Brief Title
IL-6 in Exercise-Induced Anorexia
Official Title
The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior, Pediatric Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
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).
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Water and Rest
Arm Type
No Intervention
Arm Title
Water and High Intensity Exercise
Arm Type
Experimental
Arm Title
Ibuprofen and Rest
Arm Type
Experimental
Arm Title
Ibuprofen and High Intensity Exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High Intensity Exercise/Ibuprofen
Intervention 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.
Primary Outcome Measure Information:
Title
Food Intake
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.
Time Frame
100-120 min
Title
Visual Analog Scale Appetite Scores
Description
Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.
Time Frame
0-120min
Title
Appetite Biomarkers
Description
Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
Time Frame
0-120min
Title
Inflammatory and Stress Biomarkers
Description
Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.
Time Frame
0-120min

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility 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 & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 13-18 yrs, healthy, male Exclusion Criteria: female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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.
Citations:
PubMed Identifier
22810957
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.
Results Reference
background
PubMed Identifier
26773031
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.
Results Reference
background
PubMed Identifier
11377145
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.
Results Reference
background
PubMed Identifier
21669216
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.
Results Reference
background
PubMed Identifier
25614205
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.
Results Reference
background
PubMed Identifier
10906542
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.
Results Reference
background

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IL-6 in Exercise-Induced Anorexia

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