High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition

August 9, 2018 updated by: Nick Bellissimo, Ryerson University

The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.

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.

Study Overview

Detailed Description

Twenty children 9-13 years of age will be recruited for this study. On four separate mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home. Using a 2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20 min, followed by a treatment drink of chocolate milk or water (control) consumption in 10 min. During high-intensity interval exercise treatment, 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. Blood glucose will be measured via finger-prick at baseline (-20 min), 10, 30, 60, and 90 min. Cognitive functions will be measured using a battery of cognitive tests which assess verbal declarative memory, working memory, and executive functioning, and will be measured at baseline, 10. 30. 60, and 90 min. Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS) at baseline, 10, 30, 60, and 90 min. Salivary cortisol will be assessed from saliva samples collected using the passive drool method, and will be collected at baseline, 10 and 30 min.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B 2K3
        • School of Nutrition, Ryerson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise and Chocolate Milk

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

High intensity interval exercise Chocolate Milk
Experimental: Exercise and Water

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

High intensity interval exercise Water
Experimental: Sitting and Chocolate Milk
Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk
Sitting Chocolate Milk
Experimental: Sitting and Water
Children will quietly sit for 20 minutes Children will then drink 240mL of water
Sitting Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Glycemic Response
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline salivary cortisol response
Time Frame: baseline (-20 min), and 10 and 30 min post-drink consumption
Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)
baseline (-20 min), and 10 and 30 min post-drink consumption
Change form baseline Subjective Appetite
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess appetite
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline aggression
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess aggression
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline anger
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess anger
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline excitement
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess excitement
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline disappointment
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess disappointment
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline happiness
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess happiness
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline upset
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess upset
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change form baseline frustration
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess frustration
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline alertness
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess alertness
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sadness
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess sadness
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline tension
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess tension
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline exhaustion
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess exhaustion
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
Change from baseline sleepiness
Time Frame: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
100-mm Visual Analogue Scales (VAS) will be used to assess sleepiness
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Nick Bellissimo, PHD, School of Nutrition, Ryerson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2017

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (Actual)

October 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • REB2017- 088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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