NCT03305107

Brief Summary

The purpose of this study is to determine the separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

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

July 8, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

September 29, 2017

Last Update Submit

August 9, 2018

Conditions

Keywords

ChildExerciseChocolate milkBlood glucoseCognitionAppetiteEmotionsCortisol

Outcome Measures

Primary Outcomes (4)

  • Change from baseline Glycemic Response

    Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline verbal declarative memory

    Cognitive function test of verbal declarative memory

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline working memory

    The n-back test consists of 2 levels, 1-back and 2-back, where letters are presented on the screen one at a time. During the 1-back level, participants need to determine if the presented letter is the same as the one letter presented 1 before it or not (by selected 'match' or 'no match' on the side of the screen) and during 2-back need to do determine if it is the same letter as the one presented 2 letters prior.

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline executive functioning

    The Stroop test consists of one word appearing on the screen written in either blue, red, yellow or green. There are 24 congruent trials where the presented word is the name of the colour it is written it (i.e. 'red' appearing in the colour red), 24 incongruent trials where the word written is a colour word different from the one it is written in (i.e. 'red' appearing in the colour green), and 10 neutral trials where non-colour words appear (i.e. 'tape' appearing in yellow). The participant is asked to tap the corresponding colour that the word is written in as quickly as possible.

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

Secondary Outcomes (14)

  • Change from baseline salivary cortisol response

    baseline (-20 min), and 10 and 30 min post-drink consumption

  • Change form baseline Subjective Appetite

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline aggression

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline anger

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • Change from baseline excitement

    baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

  • +9 more secondary outcomes

Study Arms (4)

Exercise and Chocolate Milk

EXPERIMENTAL

Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Children will then drink 240mL of chocolate milk

Other: Exercise and Chocolate Milk

Exercise and Water

EXPERIMENTAL

Children will exercise on a cycle ergometer with a 3-min warm-up, 7 repeated bouts of 60-sec exercise at 90% of peak power output and 60-second recovery, and a 3-min cool down. Children will then drink 240mL of water

Other: Exercise and Water

Sitting and Chocolate Milk

EXPERIMENTAL

Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk

Other: Sitting and Chocolate Milk

Sitting and Water

EXPERIMENTAL

Children will quietly sit for 20 minutes Children will then drink 240mL of water

Other: Sitting and Water

Interventions

High intensity interval exercise Chocolate Milk

Exercise and Chocolate Milk

High intensity interval exercise Water

Exercise and Water

Sitting Chocolate Milk

Sitting and Chocolate Milk

Sitting Water

Sitting and Water

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • be between 9 and 13 years of age
  • be healthy, and have been born at term
  • not be taking any medications
  • not have allergies to dairy or gluten.

You may not qualify if:

  • Food sensitivities, allergies, or dietary restrictions
  • Health, learning, emotional, or behavioural problems
  • Receiving any medications
  • Non-habitual breakfast eater (\<5 days/week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

Location

Related Publications (1)

  • Kucab M, Bellissimo N, Prusky C, Brett NR, Totosy de Zepetnek JO. Effects of a high-intensity interval training session and chocolate milk on appetite and cognitive performance in youth aged 9-13 years. Eur J Clin Nutr. 2021 Jan;75(1):172-179. doi: 10.1038/s41430-020-00718-z. Epub 2020 Aug 19.

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseWaterSitting Position

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsPosture

Study Officials

  • Nick Bellissimo, PHD

    School of Nutrition, Ryerson University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 9, 2017

Study Start

July 8, 2017

Primary Completion

December 31, 2017

Study Completion

May 31, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations