- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02484313
The Effect of Snacks on Glycaemic Regulation in Children
January 21, 2019 updated by: Mount Saint Vincent University
The Effect of Dairy and Non-Dairy Products on Blood Glucose Regulation in Children
Dairy products have a potential to be healthy snack foods for children.
The purpose of this project is to investigate the short-term effects of Greek yogurt, a new popular dairy product on the regulation of glucose homeostasis, satiety and energy intake in normal weight and overweight/obese children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
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
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3M 2J6
- Mount Saint Vincent 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
All
Description
Inclusion Criteria:
- The children must be born at full-term within the normal weight range
Exclusion Criteria:
- food sensitivities or allergies, dietary restrictions, health, learning, emotional or behavioural problems, of if children are receiving medication
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Greek yogurt
25 g available carbohydrates
|
commercially available food products
|
Experimental: Cookies
25 g available carbohydrates
|
commercially available food products
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood glucose
Time Frame: 120 min
|
concentration of blood glucose
|
120 min
|
insulin
Time Frame: 120 min
|
concentration of circulating insulin
|
120 min
|
C-peptide
Time Frame: 120 min
|
concentration of circulating C-peptide
|
120 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food intake (grams and kcal)
Time Frame: 120 min
|
ad libitum food intake at 120 min measured with a test meal (grams consumed converted to kilocalories).
|
120 min
|
Subjective appetite
Time Frame: 0-120 min
|
Four patterns of subjective appetite were measured using 100 mm visual analogue scale (VAS): desire to eat, hunger, fullness, and prospective food consumption at 0 min (immediately before the snack), 15, 30, 45, 60, 90, and immediately before the test meal at 120 min.
The average appetite was calculated.
|
0-120 min
|
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
November 1, 2011
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
April 17, 2015
First Submitted That Met QC Criteria
June 25, 2015
First Posted (Estimate)
June 29, 2015
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 21, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2011-001(2)
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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