NCT02197195

Brief Summary

The purpose of the study is to understand the role chocolate milk compared to a fruit drink, with and without exercise, on glycaemic regulation and subjective appetite in children. The investigators hypothesize that chocolate milk in combination with exercise will have the greatest effect attenuating glycaemic response. Blood glucose will be measured by finger prick following drink consumption (0 min) and exercise or sitting (15 min), and at 65 minutes. Subjective appetite will be measured at 0, 20, 35, 50 and 65 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

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

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

July 20, 2014

Last Update Submit

July 20, 2014

Conditions

Glycemic ControlSubjective Appetite

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose (mmol/L)

    Blood Glucose (mmol/L) determined by fingerprick glucometer reading

    at baseline (0), 20 and 65 minutes

Secondary Outcomes (1)

  • Subjective Appetite (mm)

    0 - 65 mins

Study Arms (4)

Chocolate Milk Beverage

EXPERIMENTAL

Chocolate milk beverage and sitting quietly

Dietary Supplement: Chocolate Milk

Chocolate Milk Beverage and Exercise

EXPERIMENTAL

Chocolate milk beverage and exercising

Dietary Supplement: Chocolate MilkBehavioral: Exercise

Fruit Drink Beverage

EXPERIMENTAL

Fruit drink beverage and sitting quietly

Dietary Supplement: Fruit Drink

Fruit Drink Beverage and Exercise

EXPERIMENTAL

Fruit drink beverage and exercising

Dietary Supplement: Fruit DrinkBehavioral: Exercise

Interventions

Chocolate MilkDIETARY_SUPPLEMENT
Chocolate Milk BeverageChocolate Milk Beverage and Exercise
Fruit DrinkDIETARY_SUPPLEMENT
Fruit Drink BeverageFruit Drink Beverage and Exercise
ExerciseBEHAVIORAL
Chocolate Milk Beverage and ExerciseFruit Drink Beverage and Exercise

Eligibility Criteria

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

You may qualify if:

  • Healthy, boy, born at full term and normal birth weight

You may not qualify if:

  • Girls, have significant learning, behavioral, or emotional difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryerson University

Toronto, Ontario, KHS344, Canada

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Assistant Professor, School of Nutrition

Study Record Dates

First Submitted

July 20, 2014

First Posted

July 22, 2014

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

CA(1)