An interventional study of High Intensity Exercise/Ibuprofen in Appetitive Behavior and Pediatric Obesity, sponsored by University of Toronto. Completed at 1 site in Canada. Open to male participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by University of Toronto · Not applicable, Interventional, and Basic science
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 15 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Toronto is the lead sponsor of 403 studies on the registry; 54 are open to participants now.
Compared within Pediatric Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Appetitive Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Other: High Intensity Exercise/Ibuprofen
Other: High Intensity Exercise/Ibuprofen
Other: High Intensity Exercise/Ibuprofen
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.
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.
Time frame: 100-120 min
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.
Time frame: 0-120min
Appetite Biomarkers
Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
Time frame: 0-120min
Inflammatory and Stress Biomarkers
Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.
Time frame: 0-120min
Plan to share: No — 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.
The record gives a start of Mar 2016, a primary completion of Oct 2016 and a completion of Oct 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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