NCT01025557

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

1.7 years

First QC Date

December 2, 2009

Last Update Submit

June 13, 2012

Conditions

Diabetes PreventionObesity Prevention

Keywords

Food intakeBlood glucoseMilk

Outcome Measures

Primary Outcomes (1)

  • Food intake

    30 minute

Secondary Outcomes (1)

  • Blood glucose

    0, 10, 20, 30, 50, 80, 110, 140 and 170 minutes

Study Arms (5)

Chocolate milk

EXPERIMENTAL
Other: Dietary intervention

Milk

EXPERIMENTAL
Other: Dietary intervention

Infant formula

EXPERIMENTAL
Other: Dietary intervention

Soy beverage

EXPERIMENTAL
Other: Dietary intervention

Water

EXPERIMENTAL
Other: Dietary intervention

Interventions

Dietary interventionOTHER

Dietary treatments with beverages

Chocolate milkInfant formulaMilkSoy beverageWater

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Harvey Anderson, Ph.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

May 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

CA(1)