Back to resultsSugars-containing Beverage and Food Intake in Children
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
water with Sucralose
water with HFCS
water with glucose
water with sucrose
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity focused on measuring boys, obesity, glucose, sucrose, high-fructose corn syrup-55
Eligibility Criteria
Inclusion Criteria:
- Healthy, boy, born at full term and normal birth weight
Exclusion Criteria:
- Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties
Sites / Locations
- Department of Applied Human Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Calorie-free control
HFCS-55 drink
Glucose drink
Sucrose drink
Arm Description
Calorie-free control
HFCS-55 drink
Glucose drink
Sucrose drink
Outcomes
Primary Outcome Measures
Food intake (kcal)
Secondary Outcome Measures
Subjective appetite (mm)
Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.
Full Information
NCT ID
NCT01717716
First Posted
October 23, 2012
Last Updated
October 26, 2012
Sponsor
Toronto Metropolitan University
Collaborators
Mount Saint Vincent University
1. Study Identification
Unique Protocol Identification Number
NCT01717716
Brief Title
Sugars-containing Beverage and Food Intake in Children
Official Title
Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake in Normal Weight 9-14 Year Old Boys
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Toronto Metropolitan University
Collaborators
Mount Saint Vincent University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
boys, obesity, glucose, sucrose, high-fructose corn syrup-55
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calorie-free control
Arm Type
Experimental
Arm Description
Calorie-free control
Arm Title
HFCS-55 drink
Arm Type
Experimental
Arm Description
HFCS-55 drink
Arm Title
Glucose drink
Arm Type
Experimental
Arm Description
Glucose drink
Arm Title
Sucrose drink
Arm Type
Experimental
Arm Description
Sucrose drink
Intervention Type
Dietary Supplement
Intervention Name(s)
water with Sucralose
Intervention Type
Dietary Supplement
Intervention Name(s)
water with HFCS
Intervention Type
Dietary Supplement
Intervention Name(s)
water with glucose
Intervention Type
Dietary Supplement
Intervention Name(s)
water with sucrose
Primary Outcome Measure Information:
Title
Food intake (kcal)
Time Frame
measured at 60 minutes after the treatment
Secondary Outcome Measure Information:
Title
Subjective appetite (mm)
Description
Subjective appetite (in mm) by visual analogue scale will be determined at 0, 15, 30, 45, 60 and 90 minutes.
Time Frame
0-90 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, boy, born at full term and normal birth weight
Exclusion Criteria:
Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Bellissimo, PhD
Organizational Affiliation
Toronto Metropolitan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Applied Human Nutrition
City
Bedford
State/Province
Nova Scotia
Country
Canada
12. IPD Sharing Statement
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Sugars-containing Beverage and Food Intake in Children
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