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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
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Experimenteel: 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
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Experimenteel: Sitting and Chocolate Milk
Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk
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Sitting Chocolate Milk
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Experimenteel: Sitting and Water
Children will quietly sit for 20 minutes Children will then drink 240mL of water
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Sitting Water
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline Glycemic Response
Tijdsspanne: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Blood samples will be collected via finger-prick method to assess glycemic response (blood glucose, mmol/L)
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline verbal declarative memory
Tijdsspanne: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Cognitive function test of verbal declarative memory
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline working memory
Tijdsspanne: 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.
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline executive functioning
Tijdsspanne: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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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.
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change from baseline salivary cortisol response
Tijdsspanne: baseline (-20 min), and 10 and 30 min post-drink consumption
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Saliva samples will be collected via passive drool method to assess salivary cortisol response (ug/dL)
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baseline (-20 min), and 10 and 30 min post-drink consumption
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Change form baseline Subjective Appetite
Tijdsspanne: 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 appetite
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline aggression
Tijdsspanne: 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 aggression
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline anger
Tijdsspanne: 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 anger
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline excitement
Tijdsspanne: 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
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline disappointment
Tijdsspanne: 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 disappointment
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline happiness
Tijdsspanne: 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 happiness
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline upset
Tijdsspanne: 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 upset
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change form baseline frustration
Tijdsspanne: 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
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline alertness
Tijdsspanne: 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 alertness
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline sadness
Tijdsspanne: 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
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline tension
Tijdsspanne: 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 tension
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline exhaustion
Tijdsspanne: 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 exhaustion
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline sleepiness
Tijdsspanne: 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 sleepiness
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- REB2017- 088
Plan Individuele Deelnemersgegevens (IPD)
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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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