- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02147496
Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children
May 21, 2014 updated by: G. Harvey Anderson, University of Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 3E2
- University of Toronto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
- Born at term
Exclusion Criteria:
- Diabetes
- Medications
- Lactose-intolerance or allergies to milk
- Breakfast skippers and those on an energy restricted diet
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2% M.F. Milk
Dietary treatment: 2% m.f.
milk
|
|
|
Experimental: 1% M.F. Chocolate Milk
Dietary treatment: 1% m.f.
chocolate milk
|
|
|
Experimental: 1.5% M.F. Drinkable Yogurt
Dietary treatment: 1.5% m.f.
drinkable yogurt
|
|
|
Experimental: Tropical Punch
Dietary treatment: fruit-flavoured beverage
|
|
|
Experimental: Water
Dietary treatment: calorie-free control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake
Time Frame: 60 minute
|
The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal.
|
60 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood glucose
Time Frame: 0, 30, 60, 85, 115, and 145 minute
|
0, 30, 60, 85, 115, and 145 minute
|
|
|
Appetite hormones
Time Frame: 0, 30, 60, 85, 115, and 145 minute
|
Insulin, total ghrelin, glucagon-like peptide-1, and peptide YY
|
0, 30, 60, 85, 115, and 145 minute
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subjective Appetite
Time Frame: 0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites
|
0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harvey Anderson, PhD, University of Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
May 21, 2014
First Posted (Estimate)
May 26, 2014
Study Record Updates
Last Update Posted (Estimate)
May 26, 2014
Last Update Submitted That Met QC Criteria
May 21, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DFC kids 25804
- DFC Kids Milk Study 491336
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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