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- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline Glycemic Response
Lasso di tempo: 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
Lasso di tempo: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline salivary cortisol response
Lasso di tempo: 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
|
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Change form baseline Subjective Appetite
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Change from baseline disappointment
Lasso di tempo: 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
Lasso di tempo: 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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline upset
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline sleepiness
Lasso di tempo: 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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- REB2017- 088
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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