NCT01272427

Brief Summary

The investigators hypothesize that glucose and whey protein given 30 and 60 min before a pizza meal will exert different effects on food intake in adolescent children, and will depend on pubertal stage. Food intake will be measured at 30 and 60 min following a glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or sweetened noncaloric beverage. Subjective appetite will be measured as well.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

2.9 years

First QC Date

January 6, 2011

Last Update Submit

February 13, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Food intake (kcal)

    30 and 60 min after the treatment

Secondary Outcomes (1)

  • subjective appetite

    0-120 min

Study Arms (6)

noncaloric beverage

EXPERIMENTAL

noncaloric sweetened beverage administered 30 min prior to mealtime

Dietary Supplement: water with noncaloric sweetener

noncaloric beverage (60 min)

EXPERIMENTAL

noncaloric sweetened beverage administered 60 min prior to mealtime

Dietary Supplement: water with noncaloric sweetener

glucose beverage

EXPERIMENTAL

glucose beverage administered 30 min prior to mealtime

Dietary Supplement: water with glucose

glucose beverage (60 min)

EXPERIMENTAL

glucose beverage administered 60 min prior to mealtime

Dietary Supplement: water with glucose

whey protein beverage

EXPERIMENTAL

whey protein beverage administered 30 min prior to mealtime

Dietary Supplement: water and whey protein

whey protein beverage (60 min)

EXPERIMENTAL

whey protein beverage administered 60 min prior to mealtime

Dietary Supplement: water and whey protein

Interventions

water with glucoseDIETARY_SUPPLEMENT

0.75 g/kg body weight of glucose added to water

glucose beverageglucose beverage (60 min)
water and whey proteinDIETARY_SUPPLEMENT

0.75 g/kg body weight of whey protein added to water

whey protein beveragewhey protein beverage (60 min)

0.15 g of sucralose added to water

noncaloric beveragenoncaloric beverage (60 min)

Eligibility Criteria

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

You may qualify if:

  • children with no emotional, behavioral or learning problems

You may not qualify if:

  • underweight children
  • children with emotional, behavioral or learning problems
  • children who dislike foods in study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Sciences

Toronto, Ontario, M5S 3E2, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

WaterGlucoseWhey Proteins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsHexosesMonosaccharidesSugarsCarbohydratesMilk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Harvey Anderson, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2011

First Posted

January 7, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations