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Completed

NCT Number: NCT03305107

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

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.

Completed

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Key information

Conditions

Glycemic Response Behavior Cognitive Function Motor Activity

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nutrition, Ryerson University

Toronto, Ontario, M5B 2K3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise and Chocolate Milk

Other

High intensity interval exercise Chocolate Milk

Exercise and Water

Other

High intensity interval exercise Water

Sitting and Chocolate Milk

Other

Sitting Chocolate Milk

Sitting and Water

Other

Sitting Water

Primary outcomes

  1. 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)

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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