- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Szczegółowy opis
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ontario
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Toronto, Ontario, Kanada, M5B 2K3
- School of Nutrition, Ryerson University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change from baseline Glycemic Response
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
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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
Ramy czasowe: 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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change from baseline salivary cortisol response
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- REB2017- 088
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Funkcja poznawcza
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