Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response

June 13, 2012 updated by: G. Harvey Anderson, University of Toronto

The Effects of Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response in Healthy Young Men and Women

The purpose of this protocol is to study the effects of fluid milk products on satiety, food intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and food intake and on blood glucose before and after a meal. A fixed volume approach is based on the commercially available serving size. Experiment 2 will examine equicaloric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a glucose drink and water (control) the treatments in order to investigate macronutrient composition on satiety and food intake and on blood glucose before and after the meal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • Canada
    • 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

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • Non-smoking
  • Aged 20-30 years
  • Body mass index between 20 and 24.9 kg/m2

Exclusion Criteria:

  • Diabetes
  • Medication
  • 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: Water
Other: Dietary intervention
Dietary treatments with beverages
Experimental: Chocolate milk
Other: Dietary intervention
Dietary treatments with beverages
Experimental: Milk
Other: Dietary intervention
Dietary treatments with beverages
Experimental: Infant formula
Other: Dietary intervention
Dietary treatments with beverages
Experimental: Soy beverage
Other: Dietary intervention
Dietary treatments with beverages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Food intake
Time Frame: 30 minute
30 minute

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood glucose
Time Frame: 0, 10, 20, 30, 50, 80, 110, 140 and 170 minutes
0, 10, 20, 30, 50, 80, 110, 140 and 170 minutes

Collaborators and Investigators

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

Sponsor

University of Toronto

Collaborators

Natural Sciences and Engineering Research Council, Canada
Mondelēz International, Inc.
Dairy Farmers of Ontario

Investigators

  • Principal Investigator: Harvey Anderson, Ph.D., 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, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Milk Study - Experiment 1
  • DFO_24235

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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