ObesityNCT01272427
Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children
A study testing water with glucose, water and whey protein and water with noncaloric sweetener in people with Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. 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 with glucose, water and whey protein and water with noncaloric sweetener
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Feb 2013
- 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
- children with no emotional, behavioral or learning problems
Who cannot join
- underweight children
- children with emotional, behavioral or learning problems
- children who dislike foods in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Glucose, Whey Protein and Time to the Next Meal on Food Intake and Subjective Appetite in Normal Weight and Overweight/Obese Children
The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.
- Conditions
- Obesity
- Being tested
- water with glucose, water and whey protein, water with noncaloric sweetener
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water with glucoseDietary supplement
0.75 g/kg body weight of glucose added to water
water and whey proteinDietary supplement
0.75 g/kg body weight of whey protein added to water
water with noncaloric sweetenerDietary supplement
0.15 g of sucralose added to water
| Study group | Role | What they receive |
|---|---|---|
| noncaloric beverage | Experimental | noncaloric sweetened beverage administered 30 min prior to mealtime Receives: Dietary Supplement: water with noncaloric sweetener |
| noncaloric beverage (60 min) | Experimental | noncaloric sweetened beverage administered 60 min prior to mealtime Receives: Dietary Supplement: water with noncaloric sweetener |
| glucose beverage | Experimental | glucose beverage administered 30 min prior to mealtime Receives: Dietary Supplement: water with glucose |
| glucose beverage (60 min) | Experimental | glucose beverage administered 60 min prior to mealtime Receives: Dietary Supplement: water with glucose |
| whey protein beverage | Experimental | whey protein beverage administered 30 min prior to mealtime Receives: Dietary Supplement: water and whey protein |
| whey protein beverage (60 min) | Experimental | whey protein beverage administered 60 min prior to mealtime Receives: Dietary Supplement: water and whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake (kcal)
Measured: 30 and 60 min after the treatment
Secondary outcomes (1)
subjective appetite
Measured: 0-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionFeb 2013
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.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- 36 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, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272427
- Sponsor's protocol ID
- FoodIntakeKids_21595
- Status last verified
- Feb 2013
- First submitted
- 6 Jan 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucose, Whey Protein and Time to the Next Meal on Food Intake and Subjective Appetite in Normal Weight and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT01272427
- Acronym / sponsor ID
- FoodIntakeKids_21595
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jan 2011 (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 that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| noncaloric beverage | Experimental | Dietary Supplement: water with noncaloric sweetenernoncaloric sweetened beverage administered 30 min prior to mealtime |
| noncaloric beverage (60 min) | Experimental | Dietary Supplement: water with noncaloric sweetenernoncaloric sweetened beverage administered 60 min prior to mealtime |
| glucose beverage | Experimental | Dietary Supplement: water with glucoseglucose beverage administered 30 min prior to mealtime |
| glucose beverage (60 min) | Experimental | Dietary Supplement: water with glucoseglucose beverage administered 60 min prior to mealtime |
| whey protein beverage | Experimental | Dietary Supplement: water and whey proteinwhey protein beverage administered 30 min prior to mealtime |
| whey protein beverage (60 min) | Experimental | Dietary Supplement: water and whey proteinwhey protein beverage administered 60 min prior to mealtime |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children with no emotional, behavioral or learning problems
Key exclusion criteria (3 listed)
- underweight children
- children with emotional, behavioral or learning problems
- children who dislike foods in study
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 glucose0.75 g/kg body weight of glucose added to water | Dietary supplement | glucose beverage, glucose beverage (60 min) |
| water and whey protein0.75 g/kg body weight of whey protein added to water | Dietary supplement | whey protein beverage, whey protein beverage (60 min) |
| water with noncaloric sweetener0.15 g of sucralose added to water | Dietary supplement | noncaloric beverage, noncaloric beverage (60 min) |
Primary outcome
Food intake (kcal)
Time frame: 30 and 60 min after the treatment
1 secondary outcome
subjective appetite
Time frame: 0-120 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 15 Feb 2013.
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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, 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 water with glucose, water and whey protein and water with noncaloric sweetener in people with 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 3 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 15 Feb 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 (kcal) (time frame: 30 and 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 15 Feb 2013.