- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305107
High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition
The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
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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
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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
Sponsor
Investigators
- Study Director: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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