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CompletedNCT03305107Updated Aug 10, 2018

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

An interventional study of Exercise and Chocolate Milk and Exercise and Water in Glycemic Response and Cognitive Function, sponsored by Toronto Metropolitan University. Completed at 1 site in Canada. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-10.

Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glycemic Response
  • Cognitive Function

Keywords

  • Child
  • Exercise
  • Chocolate milk
  • Blood glucose
  • Cognition
  • Appetite
  • Emotions
  • Cortisol
03

Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Food sensitivities, allergies, or dietary restrictions
  • Health, learning, emotional, or behavioural problems
  • Receiving any medications
  • Non-habitual breakfast eater (\<5 days/week)
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

    Other: Exercise and 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

    Other: Exercise and Water

  • Experimental
    Sitting and Chocolate Milk

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

    Other: Sitting and Chocolate Milk

  • Experimental
    Sitting and Water

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

    Other: Sitting and Water

Interventions

  • OtherExercise and Chocolate Milk

    High intensity interval exercise Chocolate Milk

  • OtherExercise and Water

    High intensity interval exercise Water

  • OtherSitting and Chocolate Milk

    Sitting Chocolate Milk

  • OtherSitting and Water

    Sitting Water

05

What researchers measure

Primary outcomes

  1. Change from baseline Glycemic Response

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

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

  2. Change from baseline verbal declarative memory

    Cognitive function test of verbal declarative memory

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. Change from baseline salivary cortisol response

    Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)

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

  2. Change form baseline Subjective Appetite

    100-mm Visual Analogue Scales (VAS) will be used to assess appetite

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

  3. Change from baseline aggression

    100-mm Visual Analogue Scales (VAS) will be used to assess aggression

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

  4. Change from baseline anger

    100-mm Visual Analogue Scales (VAS) will be used to assess anger

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

  5. Change from baseline excitement

    100-mm Visual Analogue Scales (VAS) will be used to assess excitement

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

  6. Change from baseline disappointment

    100-mm Visual Analogue Scales (VAS) will be used to assess disappointment

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

  7. Change from baseline happiness

    100-mm Visual Analogue Scales (VAS) will be used to assess happiness

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

  8. Change from baseline upset

    100-mm Visual Analogue Scales (VAS) will be used to assess upset

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

  9. Change form baseline frustration

    100-mm Visual Analogue Scales (VAS) will be used to assess frustration

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

  10. Change from baseline alertness

    100-mm Visual Analogue Scales (VAS) will be used to assess alertness

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

  11. Change from baseline sadness

    100-mm Visual Analogue Scales (VAS) will be used to assess sadness

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

  12. Change from baseline tension

    100-mm Visual Analogue Scales (VAS) will be used to assess tension

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

  13. Change from baseline exhaustion

    100-mm Visual Analogue Scales (VAS) will be used to assess exhaustion

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

  14. Change from baseline sleepiness

    100-mm Visual Analogue Scales (VAS) will be used to assess sleepiness

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

06

Study locations

1 site
  • School of Nutrition, Ryerson University
    Toronto, Ontario M5B 2K3, Canada
07

References and documents

Publications

  • 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. PubMed 32814852 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03305107
Lead sponsor
Toronto Metropolitan University
Responsible party
Nick Bellissimo (Study Director, Toronto Metropolitan University) — Principal investigator
First posted
Oct 9, 2017
Start date
Jul 8, 2017
Primary completion
Dec 31, 2017
Completion
May 31, 2018
Last update
Aug 10, 2018

Study contacts

Nick Bellissimo, PHD
study director · School of Nutrition, Ryerson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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