Childhood ObesityNCT01717716
Sugars-containing Beverage and Food Intake in Children
A study testing water with Sucralose, water with HFCS and water with glucose in people with Childhood Obesity, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI… 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
- Childhood Obesity
- What is being tested?
- water with Sucralose, water with HFCS and water with glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Sep 2011
- 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, boy, born at full term and normal birth weight
Who cannot join
- Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake in Normal Weight 9-14 Year Old Boys
The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.
- Conditions
- Childhood Obesity
- Being tested
- water with Sucralose, water with HFCS, water with glucose, water with sucrose
- Keywords
- boys, obesity, glucose, sucrose, high-fructose corn syrup-55
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water with SucraloseDietary supplement
water with HFCSDietary supplement
water with glucoseDietary supplement
water with sucroseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Calorie-free control | Experimental | Calorie-free control Receives: Dietary Supplement: water with Sucralose |
| HFCS-55 drink | Experimental | HFCS-55 drink Receives: Dietary Supplement: water with HFCS |
| Glucose drink | Experimental | Glucose drink Receives: Dietary Supplement: water with glucose |
| Sucrose drink | Experimental | Sucrose drink Receives: Dietary Supplement: water with sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake (kcal)
Measured: measured at 60 minutes after the treatment
Secondary outcomes (1)
Subjective appetite (mm)
Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.
Measured: 0-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Saint Vincent University
- Responsible party
- Principal investigator, Nick Bellissimo, Toronto Metropolitan University
- Investigators
- Nick Bellissimo, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717716
- Sponsor's protocol ID
- REB 2010-017-001
- Status last verified
- Oct 2012
- First submitted
- 23 Oct 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake in Normal Weight 9-14 Year Old Boys
- ClinicalTrials.gov ID
- NCT01717716
- Acronym / sponsor ID
- REB 2010-017-001
- Conditions
- Childhood Obesity
- Keywords
- boys, obesity, glucose, sucrose, high-fructose corn syrup-55
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Mount Saint Vincent University
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Oct 2012 (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 is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Calorie-free control | Experimental | Dietary Supplement: water with SucraloseCalorie-free control |
| HFCS-55 drink | Experimental | Dietary Supplement: water with HFCSHFCS-55 drink |
| Glucose drink | Experimental | Dietary Supplement: water with glucoseGlucose drink |
| Sucrose drink | Experimental | Dietary Supplement: water with sucroseSucrose drink |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, boy, born at full term and normal birth weight
Key exclusion criteria (1 listed)
- Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties
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 |
|---|---|---|
| water with Sucralose | Dietary supplement | Calorie-free control |
| water with HFCS | Dietary supplement | HFCS-55 drink |
| water with glucose | Dietary supplement | Glucose drink |
| water with sucrose | Dietary supplement | Sucrose drink |
Primary outcome
Food intake (kcal)
Time frame: measured at 60 minutes after the treatment
1 secondary outcome
Subjective appetite (mm)
Time frame: 0-90 minutes
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 30 Oct 2012.
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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.
Nick Bellissimo, PhD principal investigator
Toronto Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water with Sucralose, water with HFCS and water with glucose in people with Childhood Obesity, run by Toronto Metropolitan University 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 30 Oct 2012. 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: measured at 60 minutes after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2012.