Appetitive BehaviorNCT03295968
IL-6 in Exercise-Induced Anorexia
A study testing High Intensity Exercise/Ibuprofen in people with Appetitive Behavior and Pediatric Obesity, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Pediatric Obesity
- What is being tested?
- High Intensity Exercise/Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Oct 2016
- 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 13 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 yrs, healthy, male
Who cannot join
- female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys
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
- Being tested
- High Intensity Exercise/Ibuprofen
- Medical subject headings
- Appetitive Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Exercise/IbuprofenOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Water and Rest | No intervention | Not described |
| Water and High Intensity Exercise | Experimental | Not described Receives: Other: High Intensity Exercise/Ibuprofen |
| Ibuprofen and Rest | Experimental | Not described Receives: Other: High Intensity Exercise/Ibuprofen |
| Ibuprofen and High Intensity Exercise | Experimental | Not described Receives: Other: High Intensity Exercise/Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-120min
Appetite Biomarkers
Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
Measured: 0-120min
Inflammatory and Stress Biomarkers
Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.
Measured: 0-120min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295968
- Sponsor's protocol ID
- REB32277
- Status last verified
- Sep 2017
- First submitted
- 22 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.Participant's identities will be kept confidential. Records will be kept in a locked filing cabinet in the Fitzgerald building at 150 College Street, room 437. Access will be restricted to those directly involved with the project, such as the investigator and the co-investigators. Following recruitment and attainment of informed consent, participants will be given an ID # which will be used on all forms and data analysis. Informed consent forms will be kept in a locked cabinet in a locked office, contain participant names. Research records will be identified by initials, ID number, test and date. Results identified by date and ID number will only be entered on password-protected personal computers kept in locked laboratories or offices at the University of Toronto. Any electronic data will be held on encrypted computers and USB sticks for the same period of time.
Publications
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.
PubMed 22810957Anderson 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.
PubMed 26773031Banks 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.
PubMed 11377145Banks 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.
PubMed 21669216Blundell 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.
PubMed 25614205Blundell 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.
PubMed 10906542
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of IL-6 in Exercise-Induced Anorexia in Normal-weight Boys
- ClinicalTrials.gov ID
- NCT03295968
- Acronym / sponsor ID
- REB32277
- Conditions
- Appetitive Behavior, Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 Sep 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 13-18 yrs, healthy, male
Key exclusion criteria (1 listed)
- female, heamatophobia, following a diete, diagnosed with diabetes or other metabolic diseases, scoring ≥11 on an Eating Habit Questionnaire
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 |
|---|---|---|
| High Intensity Exercise/IbuprofenHIEX, 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. | Other | Ibuprofen and High Intensity Exercise, Ibuprofen and Rest, Water and High Intensity Exercise |
Primary outcome
Food Intake
Time frame: 100-120 min
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.
Visual Analog Scale Appetite Scores
Time frame: 0-120min
Visual Analog Scales were employed to assess subjective appetite based on the following questionnaires: Determination to Eat, Hunger, Fullness and Prospective Food Consumption.
Appetite Biomarkers
Time frame: 0-120min
Active Ghrelin, Blood Glucose, Insulin, Peptide-YY and Glucagon-like peptide-1 were determined as appetite biomarkers.
Inflammatory and Stress Biomarkers
Time frame: 0-120min
Interleukin-6, Tumor necrosis factor alpha and cortisol were determined as appetite biomarkers.
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 28 Sep 2017.
- Background: PubMed 22810957Almada 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.
- Background: PubMed 26773031Anderson 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.
- Background: PubMed 11377145Banks 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.
- Background: PubMed 21669216Banks 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.
- Background: PubMed 25614205Blundell 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.
- Background: PubMed 10906542Blundell 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.Participant's identities will be kept confidential. Records will be kept in a locked filing cabinet in the Fitzgerald building at 150 College Street, room 437. Access will be restricted to those directly involved with the project, such as the investigator and the co-investigators. Following recruitment and attainment of informed consent, participants will be given an ID # which will be used on all forms and data analysis. Informed consent forms will be kept in a locked cabinet in a locked office, contain participant names. Research records will be identified by initials, ID number, test and date. Results identified by date and ID number will only be entered on password-protected personal computers kept in locked laboratories or offices at the University of Toronto. Any electronic data will be held on encrypted computers and USB sticks for the same period of time.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Exercise/Ibuprofen in people with Appetitive Behavior and Pediatric 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 28 Sep 2017. 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?
Food Intake (time frame: 100-120 min). The study lists 4 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 NCT03295968, which also lists 6 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 28 Sep 2017.