- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Ontario
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Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline Glycemic Response
Tidsramme: 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)
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline verbal declarative memory
Tidsramme: 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
Tidsramme: 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
|
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Change from baseline executive functioning
Tidsramme: 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.
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baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline salivary cortisol response
Tidsramme: 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
Tidsramme: 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
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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
Tidsramme: 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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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Change from baseline anger
Tidsramme: 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
Tidsramme: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Change form baseline frustration
Tidsramme: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
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Change from baseline alertness
Tidsramme: 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
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Change from baseline sadness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- REB2017- 088
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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