- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197195
Sugars-sweetened Beverages and Exercise on Glycaemic Response and Subjective Appetite in Children
July 20, 2014 updated by: Nick Bellissimo, Ryerson University
The Role of Chocolate Milk and Fruit Drink on Subjective Appetite and Glycaemic Response With or Without Exercise in Normal Weight 9-14 Year Old Boys
The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children.
The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response.
Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes.
Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
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, KHS344
- Ryerson University
-
-
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
Male
Description
Inclusion Criteria:
- Healthy, boy, born at full term and normal birth weight
Exclusion Criteria:
- Girls, have significant learning, behavioral, or emotional difficulties
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: Chocolate Milk Beverage
Chocolate milk beverage and sitting quietly
|
|
Experimental: Chocolate Milk Beverage and Exercise
Chocolate milk beverage and exercising
|
|
Experimental: Fruit Drink Beverage
Fruit drink beverage and sitting quietly
|
|
Experimental: Fruit Drink Beverage and Exercise
Fruit drink beverage and exercising
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Glucose (mmol/L)
Time Frame: at baseline (0), 20 and 65 minutes
|
Blood Glucose (mmol/L) determined by fingerprick glucometer reading
|
at baseline (0), 20 and 65 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Appetite (mm)
Time Frame: 0 - 65 mins
|
Subjective appetite (in mm) determined by visual analogue scale will be determined at 0, 20, 35, 50 and 65 minutes.
|
0 - 65 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
July 20, 2014
First Submitted That Met QC Criteria
July 20, 2014
First Posted (Estimate)
July 22, 2014
Study Record Updates
Last Update Posted (Estimate)
July 22, 2014
Last Update Submitted That Met QC Criteria
July 20, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- REB 2013-251
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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