ObesityNCT01717703
Sugars-sweetened Commercial Beverages on Short-term Food Intake
A study testing Water, Fruit drink and Cola in people with Obesity, run by Toronto Metropolitan University at 1 site in Canada.
Trial summary
The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Water, Fruit drink and Cola
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jan 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight
Who cannot join
- restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sugars-Sweetened Commercial Beverages on Short-Term Food Intake Regulation in Normal Weight and Overweight/Obese 9-14 Year Old Boys and Girls
The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterDietary supplement
Fruit drinkDietary supplement
ColaDietary supplement
1% chocolate milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Water Control | Experimental | Water Control Receives: Dietary Supplement: Water |
| Fruit drink | Experimental | Fruit drink Receives: Dietary Supplement: Fruit drink |
| Cola | Experimental | Cola Receives: Dietary Supplement: Cola |
| 1% chocolate milk | Experimental | 1% chocolate milk Receives: Dietary Supplement: 1% chocolate milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake (kcal)
Measured: 60 min after the treatment
Secondary outcomes (1)
Subjective appetite (in mm)
Subjective appetite by visual analogue scale (mm) measured at 0, 15, 30, 45, 60 and 90 minutes.
Measured: 0-90 min
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 startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 55 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717703
- Sponsor's protocol ID
- REB 2009-020-001
- Status last verified
- Oct 2012
- First submitted
- 23 Oct 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
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
- Effect of Sugars-Sweetened Commercial Beverages on Short-Term Food Intake Regulation in Normal Weight and Overweight/Obese 9-14 Year Old Boys and Girls
- ClinicalTrials.gov ID
- NCT01717703
- Acronym / sponsor ID
- REB 2009-020-001
- Conditions
- Obesity
- Keywords
- prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Mount Saint Vincent University
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (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 of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Water Control | Experimental | Dietary Supplement: WaterWater Control |
| Fruit drink | Experimental | Dietary Supplement: Fruit drinkFruit drink |
| Cola | Experimental | Dietary Supplement: ColaCola |
| 1% chocolate milk | Experimental | Dietary Supplement: 1% chocolate milk1% chocolate milk |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight
Key exclusion criteria (1 listed)
- restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments
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 | Dietary supplement | Water Control |
| Fruit drink | Dietary supplement | Fruit drink |
| Cola | Dietary supplement | Cola |
| 1% chocolate milk | Dietary supplement | 1% chocolate milk |
Primary outcome
Food intake (kcal)
Time frame: 60 min after the treatment
1 secondary outcome
Subjective appetite (in mm)
Time frame: 0-90 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 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.
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 Water, Fruit drink and Cola in people with 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: 60 min 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.