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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02147496
Other study ID # DFC kids 25804
Secondary ID DFC Kids Milk St
Status Completed
Phase Phase 1/Phase 2
First received December 9, 2013
Last updated May 21, 2014
Start date September 2011
Est. completion date January 2013

Study information

Verified date May 2014
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Years to 14 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Dietary Intervention


Locations

Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University of Toronto Dairy Farmers of Canada, The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Subjective Appetite 0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites No
Primary Food intake The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal. 60 minute No
Secondary Blood glucose 0, 30, 60, 85, 115, and 145 minute No
Secondary Appetite hormones Insulin, total ghrelin, glucagon-like peptide-1, and peptide YY 0, 30, 60, 85, 115, and 145 minute No
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