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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03305107
Other study ID # REB2017- 088
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 8, 2017
Est. completion date May 31, 2018

Study information

Verified date August 2018
Source Ryerson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 31, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 13 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise and Chocolate Milk
High intensity interval exercise Chocolate Milk
Exercise and Water
High intensity interval exercise Water
Sitting and Chocolate Milk
Sitting Chocolate Milk
Sitting and Water
Sitting Water

Locations

Country Name City State
Canada School of Nutrition, Ryerson University Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Ryerson University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Change from baseline salivary cortisol response 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
Secondary Change form baseline Subjective Appetite 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
Secondary Change from baseline aggression 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
Secondary Change from baseline anger 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
Secondary Change from baseline excitement 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
Secondary Change from baseline disappointment 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
Secondary Change from baseline happiness 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
Secondary Change from baseline upset 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
Secondary Change form baseline frustration 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
Secondary Change from baseline alertness 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
Secondary Change from baseline sadness 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
Secondary Change from baseline tension 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
Secondary Change from baseline exhaustion 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
Secondary Change from baseline sleepiness 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
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