Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body WeightHIENCT01196364
Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake in Boys
A study testing Dietary Supplement: water with noncalorie sweetener and Activity: With noncalorie sweetener or glucose in people with Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys. Read more about this study
- Who is it for?
- Ages 9 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight
- What is being tested?
- Dietary Supplement: water with noncalorie sweetener and Activity: With noncalorie sweetener or glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Sep 2009
- 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 9 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy boys with no emotional, behavioral or learning problems
Who cannot join
- Girls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake After a Glucose Drink in Normal Weight Boys
The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys.
Read the detailed description
The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).
- Conditions
- Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight
- Being tested
- Dietary Supplement: water with noncalorie sweetener, Activity: With noncalorie sweetener or glucose
- Keywords
- Girls
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: water with noncalorie sweetenerOther
Activity: With noncalorie sweetener or glucoseOther
| Study group | Role | What they receive |
|---|---|---|
| Sedentary activity, noncaloric beverage | Experimental | Not described Receives: Other: Dietary Supplement: water with noncalorie sweetener |
| Sedentary activity, glucose beverage | Experimental | Not described Receives: Other: Dietary Supplement: water with noncalorie sweetener |
| Exercise activity, noncaloric beverage | Experimental | Not described Receives: Other: Activity: With noncalorie sweetener or glucose |
| Exercise activity, glucose beverage | Experimental | Not described Receives: Other: Activity: With noncalorie sweetener or glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
food intake (kcal)
Measured: at 30-35 min after the treatment
Secondary outcomes (1)
Subjective appetite
Measured: 0-80 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body WeightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Harvey G. Anderson, PhD., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196364
- Sponsor's protocol ID
- CIHR-Kids21595_EXR2
- Other IDs
- CIHR
- Acronym
- HIE
- Status last verified
- Sep 2010
- First submitted
- 3 Sep 2010
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19818131Bellissimo N, Desantadina MV, Pencharz PB, Berall GB, Thomas SG, Anderson GH. A comparison of short-term appetite and energy intakes in normal weight and obese boys following glucose and whey-protein drinks. Int J Obes (Lond). 2008 Feb;32(2):362-71. doi: 10.1038/sj.ijo.0803709. Epub 2007 Aug 14.
PubMed 17700578Bellissimo N, Thomas SG, Goode RC, Anderson GH. Effect of short-duration physical activity and ventilation threshold on subjective appetite and short-term energy intake in boys. Appetite. 2007 Nov;49(3):644-51. doi: 10.1016/j.appet.2007.04.004. Epub 2007 Apr 22.
PubMed 17537539
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake After a Glucose Drink in Normal Weight Boys
- ClinicalTrials.gov ID
- NCT01196364
- Acronym / sponsor ID
- HIE / CIHR-Kids21595_EXR2
- Conditions
- Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight
- Keywords
- Girls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Sep 2010 (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.
The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys.
Detailed description
The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sedentary activity, noncaloric beverage | Experimental | Other: Dietary Supplement: water with noncalorie sweetener |
| Sedentary activity, glucose beverage | Experimental | Other: Dietary Supplement: water with noncalorie sweetener |
| Exercise activity, noncaloric beverage | Experimental | Other: Activity: With noncalorie sweetener or glucose |
| Exercise activity, glucose beverage | Experimental | Other: Activity: With noncalorie sweetener or glucose |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy boys with no emotional, behavioral or learning problems
Key exclusion criteria (1 listed)
- Girls
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 |
|---|---|---|
| Dietary Supplement: water with noncalorie sweetener | Other | Sedentary activity, glucose beverage, Sedentary activity, noncaloric beverage |
| Activity: With noncalorie sweetener or glucose | Other | Exercise activity, glucose beverage, Exercise activity, noncaloric beverage |
Primary outcome
food intake (kcal)
Time frame: at 30-35 min after the treatment
1 secondary outcome
Subjective appetite
Time frame: 0-80 min
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 8 Sep 2010.
- 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.
- Background: PubMed 17700578Bellissimo N, Desantadina MV, Pencharz PB, Berall GB, Thomas SG, Anderson GH. A comparison of short-term appetite and energy intakes in normal weight and obese boys following glucose and whey-protein drinks. Int J Obes (Lond). 2008 Feb;32(2):362-71. doi: 10.1038/sj.ijo.0803709. Epub 2007 Aug 14.
- Background: PubMed 17537539Bellissimo N, Thomas SG, Goode RC, Anderson GH. Effect of short-duration physical activity and ventilation threshold on subjective appetite and short-term energy intake in boys. Appetite. 2007 Nov;49(3):644-51. doi: 10.1016/j.appet.2007.04.004. Epub 2007 Apr 22.
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 G. Anderson, PhD. 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 Dietary Supplement: water with noncalorie sweetener and Activity: With noncalorie sweetener or glucose in people with Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight, 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 8 Sep 2010. 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 (kcal) (time frame: at 30-35 min after the treatment). 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 NCT01196364, which also lists 3 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 8 Sep 2010.