Food Intake RegulationNCT01888991
Substrate Oxidation Does Not Affect Short Term Food Intake in Healthy Boys and Men
A study testing Glucose Preload and Exercise Intervention in people with Food Intake Regulation and Substrate Oxidation, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effect of substrate oxidation, expressed by RER, on food intake regulation and net energy balance. Read more about this study
- Who is it for?
- Ages 9 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Food Intake Regulation, Substrate Oxidation
- What is being tested?
- Glucose Preload and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Aug 2012
- 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 29 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Born at full term
- Men Age:20-29 years/BMI: 20-25
- Boys Age 9-11/BMI percentile: 15th to 85th:
Who cannot join
- Smokers
- Dieters
- Individuals with lactose intolerance, allergies to milk and dairy products
- Individuals with gastrointestinal problems
- Individuals with diabetes or other metabolic diseases
- Individuals scoring ≥ 11 on an Eating Habit Questionnaire
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: Substrate Oxidation Does Not Affect Short Term Food Intake in Healthy Boys and Men.
The purpose of this study is to investigate the effect of substrate oxidation, expressed by RER, on food intake regulation and net energy balance.
Read the detailed description
The relationship between substrate oxidation as measured by respiratory exchange ratio (RER) and food intake is undefined. This study is examining the effects of three modulators of substrate oxidation (RER), a glucose preload, exercise and age food intake regulation and net energy balance in normal-weight boys (9-12 y) and men (20-30 y).
Subjects (15 boys, 15 men) were measured in random order with treatments of beverages of either water or glucose followed by either moderate exercise or rest for 40 min. Measures included RER via indirect calorimetry, energy expenditure, subjective appetite, food intake measured at an ad libitum pizza meal and net energy balance as the sum of the calories of the glucose preload + calories from the pizza lunch minus energy expended at exercise or rest.
- Conditions
- Food Intake Regulation, Substrate Oxidation
- Being tested
- Glucose Preload and Exercise Intervention
- Keywords
- Glucose, Exercise, Metabolic flexibility, Substrate Oxidation, Food intake
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose Preload and Exercise InterventionOther
A glucose preload and exercise were administered to examine the modulate substrate oxidation
| Study group | Role | What they receive |
|---|---|---|
| water with resting condition | No intervention | Not described |
| glucose with resting condition | Experimental | Not described Receives: Other: Glucose Preload and Exercise Intervention |
| water with exercise condition | Experimental | Not described Receives: Other: Glucose Preload and Exercise Intervention |
| glucose with exercise condition | Experimental | Not described Receives: Other: Glucose Preload and Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Intake
Energy intake from the ad libitum the pizza meal at 60 min was calculated based on the weight consumed and the compositional information provided by the manufacturer.
Measured: 60 - 90 min in the study
Secondary outcomes (1)
Net Energy Balance
Will be calculated from the energy consumed by the glucose preload and the pizza meal minus energy expended at the exercise.
Measured: 0-90 min in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
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 Food Intake RegulationStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- Harvey Anderson, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888991
- Sponsor's protocol ID
- CIHR kids_26570
- Other IDs
- CIHR MOP-111250
- Status last verified
- Jun 2013
- First submitted
- 22 Jun 2013
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22530879Bellissimo 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 17537539Bozinovski 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, 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 25603432
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Oxidation Does Not Affect Short Term Food Intake in Healthy Boys and Men.
- ClinicalTrials.gov ID
- NCT01888991
- Acronym / sponsor ID
- CIHR kids_26570
- Conditions
- Food Intake Regulation, Substrate Oxidation
- Keywords
- Glucose, Exercise, Metabolic flexibility, Substrate Oxidation, Food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Jun 2013 (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 purpose of this study is to investigate the effect of substrate oxidation, expressed by RER, on food intake regulation and net energy balance.
Detailed description
The relationship between substrate oxidation as measured by respiratory exchange ratio (RER) and food intake is undefined. This study is examining the effects of three modulators of substrate oxidation (RER), a glucose preload, exercise and age food intake regulation and net energy balance in normal-weight boys (9-12 y) and men (20-30 y).
Subjects (15 boys, 15 men) were measured in random order with treatments of beverages of either water or glucose followed by either moderate exercise or rest for 40 min. Measures included RER via indirect calorimetry, energy expenditure, subjective appetite, food intake measured at an ad libitum pizza meal and net energy balance as the sum of the calories of the glucose preload + calories from the pizza lunch minus energy expended at exercise or rest.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| water with resting condition | No intervention | – |
| glucose with resting condition | Experimental | Other: Glucose Preload and Exercise Intervention |
| water with exercise condition | Experimental | Other: Glucose Preload and Exercise Intervention |
| glucose with exercise condition | Experimental | Other: Glucose Preload and Exercise Intervention |
Who may qualify
- Ages
- 9 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Born at full term
- Men Age:20-29 years/BMI: 20-25
- Boys Age 9-11/BMI percentile: 15th to 85th:
Key exclusion criteria (6 listed)
- Smokers
- Dieters
- Individuals with lactose intolerance, allergies to milk and dairy products
- Individuals with gastrointestinal problems
- Individuals with diabetes or other metabolic diseases
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 |
|---|---|---|
| Glucose Preload and Exercise InterventionA glucose preload and exercise were administered to examine the modulate substrate oxidation | Other | glucose with exercise condition, glucose with resting condition, water with exercise condition |
Primary outcome
Food Intake
Time frame: 60 - 90 min in the study
Energy intake from the ad libitum the pizza meal at 60 min was calculated based on the weight consumed and the compositional information provided by the manufacturer.
1 secondary outcome
Net Energy Balance
Time frame: 0-90 min in the study
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 Jun 2013.
- 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 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.
- 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 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.
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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, Ph.D. 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 Glucose Preload and Exercise Intervention in people with Food Intake Regulation and Substrate Oxidation, 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 3 inclusion and 6 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 Jun 2013. 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: 60 - 90 min in the study). 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 NCT01888991, 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 28 Jun 2013; AzTrials last refreshed its copy on 27 Oct 2026.