IL-6 in Exercise-Induced Anorexia

NCT03295968 | Completed

• 1 other identifier: REB32277
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior; Pediatric Obesity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

Water and Rest

NO INTERVENTION

Water and High Intensity Exercise

EXPERIMENTAL

Other: High Intensity Exercise/Ibuprofen

Ibuprofen and Rest

EXPERIMENTAL

Other: High Intensity Exercise/Ibuprofen

Ibuprofen and High Intensity Exercise

EXPERIMENTAL

Other: High Intensity Exercise/Ibuprofen

Interventions

High Intensity Exercise/Ibuprofen OTHER

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.

Ibuprofen and High Intensity Exercise; Ibuprofen and Rest; Water and High Intensity Exercise

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• yrs, healthy, male

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related 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.

  PMID: 22810957 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Appetitive Behavior; Pediatric Obesity

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 28, 2017
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)