Cognitive Function Clinical Trial
Official title:
The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.
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 |
Verified date | August 2018 |
Source | Ryerson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Canada | School of Nutrition, Ryerson University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ryerson University |
Canada,
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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