Diabetes PreventionPhase 1/2NCT02147496
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
A Phase 1/2 study testing Dietary Intervention in people with Diabetes Prevention and Obesity Prevention, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- Dietary Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jan 2013
- Phase
- Phase 1/2
- 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
- Born at term
Who cannot join
- Diabetes
- Medications
- Lactose-intolerance or allergies to milk
- Breakfast skippers and those on an energy restricted diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Regulation, Food Intake and Satiety in Normal Weight and Overweight/Obese Children
The purpose of this study is to examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F. yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and tropical punch consumed before and with a pizza meal 60 min later on food intake, blood glucose, and appetite hormone response.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- Dietary Intervention
- Keywords
- Food intake, Appetite, Blood glucose, Insulin, Dairy, Milk
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| 2% M.F. Milk | Experimental | Dietary treatment: 2% m.f. milk Receives: Other: Dietary Intervention |
| 1% M.F. Chocolate Milk | Experimental | Dietary treatment: 1% m.f. chocolate milk Receives: Other: Dietary Intervention |
| 1.5% M.F. Drinkable Yogurt | Experimental | Dietary treatment: 1.5% m.f. drinkable yogurt Receives: Other: Dietary Intervention |
| Tropical Punch | Experimental | Dietary treatment: fruit-flavoured beverage Receives: Other: Dietary Intervention |
| Water | Experimental | Dietary treatment: calorie-free control Receives: Other: Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal.
Measured: 60 minute
Secondary outcomes (2)
Blood glucose
Measured: 0, 30, 60, 85, 115, and 145 minute
Appetite hormones
Insulin, total ghrelin, glucagon-like peptide-1, and peptide YY
Measured: 0, 30, 60, 85, 115, and 145 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes PreventionStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada, The Hospital for Sick Children
- 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
- NCT02147496
- Sponsor's protocol ID
- DFC kids 25804
- Other IDs
- DFC Kids Milk Study 491336
- Status last verified
- May 2014
- First submitted
- 9 Dec 2013
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Regulation, Food Intake and Satiety in Normal Weight and Overweight/Obese Children
- ClinicalTrials.gov ID
- NCT02147496
- Acronym / sponsor ID
- DFC kids 25804
- Conditions
- Diabetes Prevention, Obesity Prevention
- Keywords
- Food intake, Appetite, Blood glucose, Insulin, Dairy, Milk
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada, The Hospital for Sick Children
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 May 2014 (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 examine the effects of fluid dairy products on blood glucose and insulin, satiety and energy intake in normal weight and overweight/obese children in the age range of 9-14 y. Experiment 1: The specific objective is to examine the effects of isocaloric and isovolumetric amounts of 2% M.F. milk, 1% M.F. chocolate milk, 1.5% M.F. yogurt drink, tropical punch and water consumed before and within a pizza meal 60 min later on appetite and food intake. Experiment 2 will compare the effects of 2% M.F. milk and tropical punch consumed before and with a pizza meal 60 min later on food intake, blood glucose, and appetite hormone response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2% M.F. Milk | Experimental | Other: Dietary InterventionDietary treatment: 2% m.f. milk |
| 1% M.F. Chocolate Milk | Experimental | Other: Dietary InterventionDietary treatment: 1% m.f. chocolate milk |
| 1.5% M.F. Drinkable Yogurt | Experimental | Other: Dietary InterventionDietary treatment: 1.5% m.f. drinkable yogurt |
| Tropical Punch | Experimental | Other: Dietary InterventionDietary treatment: fruit-flavoured beverage |
| Water | Experimental | Other: Dietary InterventionDietary treatment: calorie-free control |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy
- Born at term
Key exclusion criteria (4 listed)
- Diabetes
- Medications
- Lactose-intolerance or allergies to milk
- Breakfast skippers and those on an energy restricted diet
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 Intervention | Other | 1% M.F. Chocolate Milk, 1.5% M.F. Drinkable Yogurt, 2% M.F. Milk, Tropical Punch, Water |
Primary outcome
Food intake
Time frame: 60 minute
The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal.
2 secondary outcomes
Blood glucose
Time frame: 0, 30, 60, 85, 115, and 145 minute
Appetite hormones
Time frame: 0, 30, 60, 85, 115, and 145 minute
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 26 May 2014.
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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 Phase 1/2 study testing Dietary Intervention in people with Diabetes Prevention and Obesity Prevention, 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 2 inclusion and 4 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 26 May 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 minute). 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 26 May 2014.