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Clinical Trials/NCT02147496
NCT02147496CompletedPhase 1

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

University of Toronto1 site in 1 country57 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
57
Locations
1
Primary Endpoint
Food intake

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Investigator)

Eligibility Criteria

Ages
9 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Born at term

Exclusion Criteria

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

Arms & Interventions

2% M.F. Milk

Experimental

Dietary treatment: 2% m.f. milk

Intervention: Dietary Intervention (Other)

1% M.F. Chocolate Milk

Experimental

Dietary treatment: 1% m.f. chocolate milk

Intervention: Dietary Intervention (Other)

1.5% M.F. Drinkable Yogurt

Experimental

Dietary treatment: 1.5% m.f. drinkable yogurt

Intervention: Dietary Intervention (Other)

Tropical Punch

Experimental

Dietary treatment: fruit-flavoured beverage

Intervention: Dietary Intervention (Other)

Water

Experimental

Dietary treatment: calorie-free control

Intervention: Dietary Intervention (Other)

Outcomes

Primary Outcomes

Food intake

Time Frame: 60 minute

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

Secondary Outcomes

  • Blood glucose(0, 30, 60, 85, 115, and 145 minute)
  • Appetite hormones(0, 30, 60, 85, 115, and 145 minute)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

G. Harvey Anderson

Professor

University of Toronto

Study Sites (1)

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