- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272427
Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children
February 13, 2013 updated by: G. Harvey Anderson, University of Toronto
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
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
- Department of Nutritional Sciences
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children with no emotional, behavioral or learning problems
Exclusion Criteria:
- underweight children
- children with emotional, behavioral or learning problems
- children who dislike foods in study
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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: noncaloric beverage
noncaloric sweetened beverage administered 30 min prior to mealtime
|
0.15 g of sucralose added to water
|
Experimental: noncaloric beverage (60 min)
noncaloric sweetened beverage administered 60 min prior to mealtime
|
0.15 g of sucralose added to water
|
Experimental: glucose beverage
glucose beverage administered 30 min prior to mealtime
|
0.75 g/kg body weight of glucose added to water
|
Experimental: glucose beverage (60 min)
glucose beverage administered 60 min prior to mealtime
|
0.75 g/kg body weight of glucose added to water
|
Experimental: whey protein beverage
whey protein beverage administered 30 min prior to mealtime
|
0.75 g/kg body weight of whey protein added to water
|
Experimental: whey protein beverage (60 min)
whey protein beverage administered 60 min prior to mealtime
|
0.75 g/kg body weight of whey protein added to water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Food intake (kcal)
Time Frame: 30 and 60 min after the treatment
|
30 and 60 min after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subjective appetite
Time Frame: 0-120 min
|
0-120 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
January 6, 2011
First Submitted That Met QC Criteria
January 6, 2011
First Posted (Estimate)
January 7, 2011
Study Record Updates
Last Update Posted (Estimate)
February 15, 2013
Last Update Submitted That Met QC Criteria
February 13, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- FoodIntakeKids_21595
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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