NCT02619461

Brief Summary

This study describes the effect of acute high intensity exercise at 70% VO2peak on inflammation, stress, appetite hormones and appetite in lean and obese children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

May 27, 2015

Last Update Submit

November 29, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

  • Appetite as assessed via visual analog scales

    Appetite will be assessed via visual analog scales. Each item will be scored from 0-100; 0 not hungry; 100 very hungry

    Timeperiod of 2 hours during each study intervention.

  • Biomarkers of appetite

    Biomarkers of appetite will be assessed such as A. Ghrelin; GLP-1; PYY and Leptin

    4 timpoints during 2 hours during each study intervention.

  • Biomarkers of Inflammation

    Biomarkers of inflammation will be assessed such as IL-6; IL-1beta; TNF-alpha; CRP

    4 timpoints during 2 hours during each study intervention.

Secondary Outcomes (1)

  • Biomarkers of Stress

    4 timpoints during 2 hours during each study intervention.

Study Arms (2)

Exercise

EXPERIMENTAL

Exercise at 70%VO2max on a recumbent bicycle for 30 minutes.

Other: Exercise

Control

NO INTERVENTION

Resting

Interventions

ExerciseOTHER

Exercise at 70%VO2max on a recumbent bicycle for 30 minutes to investigate the effects of exercise at high intensities on appetite and biomarkers of appetite and inflammation.

Exercise

Eligibility Criteria

Age10 Years - 18 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • normal weight and 11 obese boys will be recruited for the study. Lean and obese boys aged 10-18 years, born full-term and with a normal body weight at birth, will be included in the study

You may not qualify if:

  • Dieters and individuals with lactose intolerance, allergies to milk and dairy products and gastrointestinal problems will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (4)

  • Hunschede S, El Khoury D, Antoine-Jonville S, Smith C, Thomas S, Anderson GH. Acute changes in substrate oxidation do not affect short-term food intake in healthy boys and men. Appl Physiol Nutr Metab. 2015 Feb;40(2):168-77. doi: 10.1139/apnm-2014-0188. Epub 2014 Oct 22.

    PMID: 25603432BACKGROUND

  • Tamam S, Bellissimo N, Patel BP, Thomas SG, Anderson GH. Overweight and obese boys reduce food intake in response to a glucose drink but fail to increase intake in response to exercise of short duration. Appl Physiol Nutr Metab. 2012 Jun;37(3):520-9. doi: 10.1139/h2012-038. Epub 2012 Apr 25.

    PMID: 22530879BACKGROUND

  • Bozinovski NC, Bellissimo N, Thomas SG, Pencharz PB, Goode RC, Anderson GH. The effect of duration of exercise at the ventilation threshold on subjective appetite and short-term food intake in 9 to 14 year old boys and girls. Int J Behav Nutr Phys Act. 2009 Oct 9;6:66. doi: 10.1186/1479-5868-6-66.

    PMID: 19818131BACKGROUND

  • Hunschede S, Kubant R, Akilen R, Thomas S, Anderson GH. Decreased Appetite after High-Intensity Exercise Correlates with Increased Plasma Interleukin-6 in Normal-Weight and Overweight/Obese Boys. Curr Dev Nutr. 2017 Feb 28;1(3):e000398. doi: 10.3945/cdn.116.000398. eCollection 2017 Mar.

    PMID: 29955695DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Harvey Anderson

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Investigator

Study Record Dates

First Submitted

May 27, 2015

First Posted

December 2, 2015

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CA(1)