ObesityNCT02619461
The Acute Effect of Exercise on Appetite Appetite-regulating Hormones and Inflammation in Children
A study testing Exercise in people with Obesity, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 11 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
Who cannot join
- Dieters and individuals with lactose intolerance, allergies to milk and dairy products and gastrointestinal problems will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of High Intensity Exercise on Appetite, Appetite-regulating Hormones, and Bio-markers of Inflammation and Stress in Lean and Obese Boys
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.
Read the detailed description
In summary, exercise does induce a variety of metabolic mechanisms on a central and peripheral level, related to appetite other than solely gut peptides. The literature points towards a rather loose coupling when it comes to high intensity exercise and the suppression of food intake, without a clear explanation of the cause of exercise induced anorexia. This study is aimed to investigate high-intensity exercise and its effects on appetite and satiety hormones, inflammation, stress and eating behaviors on appetite and food intake.
The objective of the current study is to investigate the factors contributing to exercise-induced anorexia in lean and obese children, and maximize its translation into post-exercise suppression of food intake and promotion of negative energy balance particularly in obese children. It is hypothesized that high-intensity exercise would promote a greater suppression of food intake through suppression of appetite ratings via physiological mechanisms depending on stress and inflammation rather than gut peptides.
- Conditions
- Obesity
- Being tested
- Exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise at 70%VO2max on a recumbent bicycle for 30 minutes. Receives: Other: Exercise |
| Control | No intervention | Resting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 4 timpoints during 2 hours during each study intervention.
Secondary outcomes (1)
Biomarkers of Stress
Biomarkers of stress will be assessed such as Cortisol and Adrenalin
Measured: 4 timpoints during 2 hours during each study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey Anderson, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619461
- Sponsor's protocol ID
- HIT_Exercise_Appetite_001
- Status last verified
- Nov 2015
- First submitted
- 27 May 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25603432Tamam 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.
PubMed 22530879Bozinovski 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.
PubMed 19818131Hunschede 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.
PubMed 29955695
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of High Intensity Exercise on Appetite, Appetite-regulating Hormones, and Bio-markers of Inflammation and Stress in Lean and Obese Boys
- ClinicalTrials.gov ID
- NCT02619461
- Acronym / sponsor ID
- HIT_Exercise_Appetite_001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In summary, exercise does induce a variety of metabolic mechanisms on a central and peripheral level, related to appetite other than solely gut peptides. The literature points towards a rather loose coupling when it comes to high intensity exercise and the suppression of food intake, without a clear explanation of the cause of exercise induced anorexia. This study is aimed to investigate high-intensity exercise and its effects on appetite and satiety hormones, inflammation, stress and eating behaviors on appetite and food intake.
The objective of the current study is to investigate the factors contributing to exercise-induced anorexia in lean and obese children, and maximize its translation into post-exercise suppression of food intake and promotion of negative energy balance particularly in obese children. It is hypothesized that high-intensity exercise would promote a greater suppression of food intake through suppression of appetite ratings via physiological mechanisms depending on stress and inflammation rather than gut peptides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseExercise at 70%VO2max on a recumbent bicycle for 30 minutes. |
| Control | No intervention | –Resting |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 11 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
Key exclusion criteria (1 listed)
- Dieters and individuals with lactose intolerance, allergies to milk and dairy products and gastrointestinal problems will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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. | Other | Exercise |
Primary outcome
Appetite as assessed via visual analog scales
Time frame: Timeperiod of 2 hours during each study intervention.
Appetite will be assessed via visual analog scales. Each item will be scored from 0-100; 0 not hungry; 100 very hungry
Biomarkers of appetite
Time frame: 4 timpoints during 2 hours during each study intervention.
Biomarkers of appetite will be assessed such as A. Ghrelin; GLP-1; PYY and Leptin
Biomarkers of Inflammation
Time frame: 4 timpoints during 2 hours during each study intervention.
Biomarkers of inflammation will be assessed such as IL-6; IL-1beta; TNF-alpha; CRP
1 secondary outcome
Biomarkers of Stress
Time frame: 4 timpoints during 2 hours during each study intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 25603432Hunschede 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.
- Background: PubMed 22530879Tamam 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.
- Background: PubMed 19818131Bozinovski 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.
- Derived from this study: PubMed 29955695Hunschede 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvey Anderson principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appetite as assessed via visual analog scales (time frame: Timeperiod of 2 hours during each study intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619461, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.