Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Response, Food Intake and Satiety in Children

Obesity Prevention Clinical Trial

Official title:

The Effect of Fluid Dairy Products Consumed Before and Within a Pizza Meal on Glycemic Regulation, Food Intake and Satiety in Normal Weight and Overweight/Obese Children

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

• Diabetes Prevention
• Obesity Prevention

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