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IL-6 in Exercise-Induced Anorexia

NCT ID: NCT03295968

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appetitive Behavior Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
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).

Study Groups

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Water and Rest

Group Type NO_INTERVENTION

No interventions assigned to this group

Water and High Intensity Exercise

Group Type EXPERIMENTAL

High Intensity Exercise/Ibuprofen

Intervention Type 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 Rest

Group Type EXPERIMENTAL

High Intensity Exercise/Ibuprofen

Intervention Type 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

Group Type EXPERIMENTAL

High Intensity Exercise/Ibuprofen

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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G. Harvey Anderson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 22810957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26773031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11377145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21669216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25614205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10906542 (View on PubMed)

Other Identifiers

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REB32277

Identifier Type: -

Identifier Source: org_study_id