- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Ontario
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Toronto, Ontario, Kanada, M5B 2K3
- School of Nutrition, Ryerson University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Experimentell: 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
|
Experimentell: Sitting and Chocolate Milk
Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk
|
Sitting Chocolate Milk
|
Experimentell: Sitting and Water
Children will quietly sit for 20 minutes Children will then drink 240mL of water
|
Sitting Water
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline Glycemic Response
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
Tidsram: 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
Tidsram: 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
|
Change from baseline executive functioning
Tidsram: 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.
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change from baseline salivary cortisol response
Tidsram: 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
|
Change form baseline Subjective Appetite
Tidsram: 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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Change from baseline aggression
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline anger
Tidsram: 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
Tidsram: 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
|
Change from baseline disappointment
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline happiness
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline upset
Tidsram: 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
|
Change form baseline frustration
Tidsram: 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
|
Change from baseline alertness
Tidsram: 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
|
Change from baseline sadness
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline tension
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline exhaustion
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Change from baseline sleepiness
Tidsram: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- REB2017- 088
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