NCT02147496

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

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, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

December 9, 2013

Last Update Submit

May 21, 2014

Conditions

Keywords

Food intakeAppetiteBlood glucoseInsulinDairyMilk

Outcome Measures

Primary Outcomes (1)

  • Food intake

    The amount of food (grams) and energy (kcal) consumed ad libidum with the test meal.

    60 minute

Secondary Outcomes (2)

  • Blood glucose

    0, 30, 60, 85, 115, and 145 minute

  • Appetite hormones

    0, 30, 60, 85, 115, and 145 minute

Other Outcomes (1)

  • Subjective Appetite

    0, 10, 20, 30, 60, 85, 95, 105, 115, and 145 minuites

Study Arms (5)

2% M.F. Milk

EXPERIMENTAL

Dietary treatment: 2% m.f. milk

Other: Dietary Intervention

1% M.F. Chocolate Milk

EXPERIMENTAL

Dietary treatment: 1% m.f. chocolate milk

Other: Dietary Intervention

1.5% M.F. Drinkable Yogurt

EXPERIMENTAL

Dietary treatment: 1.5% m.f. drinkable yogurt

Other: Dietary Intervention

Tropical Punch

EXPERIMENTAL

Dietary treatment: fruit-flavoured beverage

Other: Dietary Intervention

Water

EXPERIMENTAL

Dietary treatment: calorie-free control

Other: Dietary Intervention

Interventions

1% M.F. Chocolate Milk1.5% M.F. Drinkable Yogurt2% M.F. MilkTropical PunchWater

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • Born at term

You may not qualify if:

  • Diabetes
  • Medications
  • 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

Conditions

Insulin Resistance

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Harvey Anderson, PhD

    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 9, 2013

First Posted

May 26, 2014

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations