NCT01717703

Brief Summary

The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
Last Updated

October 30, 2012

Status Verified

October 1, 2012

Enrollment Period

2 years

First QC Date

October 23, 2012

Last Update Submit

October 29, 2012

Conditions

Obesity

Keywords

prevention

Outcome Measures

Primary Outcomes (1)

  • Food intake (kcal)

    60 min after the treatment

Secondary Outcomes (1)

  • Subjective appetite (in mm)

    0-90 min

Study Arms (4)

Water Control

EXPERIMENTAL

Water Control

Dietary Supplement: Water

Fruit drink

EXPERIMENTAL

Fruit drink

Dietary Supplement: Fruit drink

Cola

EXPERIMENTAL

Cola

Dietary Supplement: Cola

1% chocolate milk

EXPERIMENTAL

1% chocolate milk

Dietary Supplement: 1% chocolate milk

Interventions

WaterDIETARY_SUPPLEMENT
Water Control
Fruit drinkDIETARY_SUPPLEMENT
Fruit drink
ColaDIETARY_SUPPLEMENT
Cola
1% chocolate milkDIETARY_SUPPLEMENT
1% chocolate milk

Eligibility Criteria

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

You may qualify if:

  • healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight

You may not qualify if:

  • restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Applied Human Nutrition

Bedford, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

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
Assisstant Professor

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 30, 2012

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

CA(1)