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

May 21, 2014 updated by: G. Harvey Anderson, University of Toronto

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 1

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, M5S 3E2
        • University of Toronto

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:

  • Healthy
  • Born at term

Exclusion Criteria:

  • Diabetes
  • Medications
  • Lactose-intolerance or allergies to milk
  • Breakfast skippers and those on an energy restricted diet

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2% M.F. Milk
Dietary treatment: 2% m.f. milk
Experimental: 1% M.F. Chocolate Milk
Dietary treatment: 1% m.f. chocolate milk
Experimental: 1.5% M.F. Drinkable Yogurt
Dietary treatment: 1.5% m.f. drinkable yogurt
Experimental: Tropical Punch
Dietary treatment: fruit-flavoured beverage
Experimental: Water
Dietary treatment: calorie-free control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food intake
Time Frame: 60 minute
The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal.
60 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: 0, 30, 60, 85, 115, and 145 minute
0, 30, 60, 85, 115, and 145 minute
Appetite hormones
Time Frame: 0, 30, 60, 85, 115, and 145 minute
Insulin, total ghrelin, glucagon-like peptide-1, and peptide YY
0, 30, 60, 85, 115, and 145 minute

Other Outcome Measures

Outcome Measure
Time Frame
Subjective Appetite
Time Frame: 0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites
0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

May 26, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • DFC kids 25804
  • DFC Kids Milk Study 491336

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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