IL-6 in Exercise-Induced Anorexia

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295968
• Other study ID #: REB32277
• Status: Completed
• Phase: N/A
• First received: September 22, 2017
• Last updated: September 27, 2017
• Start date: March 2016
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Appetitive Behavior
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. Review. — View 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. Review. — View Citation

Banks WA. Anorectic effects of circulating cytokines: role of the vascular blood-brain barrier. Nutrition. 2001 May;17(5):434-7. Review. — View 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. Review. — View Citation

Blundell JE, King NA. Exercise, appetite control, and energy balance. Nutrition. 2000 Jul-Aug;16(7-8):519-22. Review. — View Citation

Outcome

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