IL-6 in Exercise-Induced Anorexia

Study Overview
=================
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.

Official Title
-----------------
The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys

Conditions
-----------------
Appetitive Behavior, Pediatric Obesity

Intervention / Treatment
-----------------
* Other: High Intensity Exercise/Ibuprofen


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Water and Rest<br> | |
| Experimental: Water and High Intensity Exercise<br> | Other: High Intensity Exercise/Ibuprofen<br>* 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.<br>|
| Experimental: Ibuprofen and Rest<br> | Other: High Intensity Exercise/Ibuprofen<br>* 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.<br>|
| Experimental: Ibuprofen and High Intensity Exercise<br> | Other: High Intensity Exercise/Ibuprofen<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 0-120min | 
| Appetite Biomarkers | Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers. | 0-120min | 
| Inflammatory and Stress Biomarkers | Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers. | 0-120min |