High-intensity Interval Exercise and Chocolate Milk on Blood Glucose and Cognition
9. august 2018 oppdatert av: Nick Bellissimo, Ryerson University
The Effects of High-intensity Interval Exercise and Chocolate Milk on Glycemic Control and Cognitive Function in Children.
The purpose of this study is to determine the separate and combined effects of high-intensity interval exercise and chocolate milk on glycemic response, cognitive function, subjective appetite, and salivary cortisol among children aged 9-13 year old children.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Twenty children 9-13 years of age will be recruited for this study.
On four separate mornings, after a 10 hour overnight fast, each child will consume a standardized breakfast (including orange juice, a strawberry breakfast bar and a pear fruit cup) at home.
Using a 2x2 factorial design, 2 hours after breakfast consumption, each participant will arrive in the lab (T=-20 min) and participate in high-intensity interval exercise or sit quietly for 20 min, followed by a treatment drink of chocolate milk or water (control) consumption in 10 min.
During high-intensity interval exercise treatment, 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.
Blood glucose will be measured via finger-prick at baseline (-20 min), 10, 30, 60, and 90 min.
Cognitive functions will be measured using a battery of cognitive tests which assess verbal declarative memory, working memory, and executive functioning, and will be measured at baseline, 10. 30.
60, and 90 min.
Subjective appetite and emotions will be measured using a 100-mm visual analogue scale (VAS) at baseline, 10, 30, 60, and 90 min.
Salivary cortisol will be assessed from saliva samples collected using the passive drool method, and will be collected at baseline, 10 and 30 min.
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
9 år til 13 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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
|
|
Eksperimentell: Sitting and Chocolate Milk
Children will quietly sit for 20 minutes Children will then drink 240mL of chocolate milk
|
Sitting Chocolate Milk
|
|
Eksperimentell: Sitting and Water
Children will quietly sit for 20 minutes Children will then drink 240mL of water
|
Sitting Water
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline Glycemic Response
Tidsramme: 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
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
|
|
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.
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
|
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
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline aggression
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 aggression
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
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
|
|
Change from baseline disappointment
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 disappointment
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline happiness
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 happiness
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
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
|
|
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
|
|
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
|
|
Change from baseline sadness
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 sadness
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline tension
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 tension
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline exhaustion
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 exhaustion
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
|
Change from baseline sleepiness
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 sleepiness
|
baseline (-20 min), and 10, 30, 60, and 90 min post-drink consumption
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Nick Bellissimo, PHD, School of Nutrition, Ryerson University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. juli 2017
Primær fullføring (Faktiske)
31. desember 2017
Studiet fullført (Faktiske)
31. mai 2018
Datoer for studieregistrering
Først innsendt
29. september 2017
Først innsendt som oppfylte QC-kriteriene
6. oktober 2017
Først lagt ut (Faktiske)
9. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. august 2018
Sist bekreftet
1. august 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- REB2017- 088
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Kognitiv funksjon
-
Incyte CorporationTilgjengeligSTAT1 Gain-of-Function sykdom
-
Massachusetts General HospitalTilbaketrukketADHD | Executive Function Deficits (EFD-er)
-
Massachusetts General HospitalThe American Professional Society of ADHD and Related Disorders (APSARD)FullførtAttention Deficit Hyperactivity Disorder (ADHD) | Executive Function Deficits (EFD)Forente stater
-
Thammasat UniversityNational Research Council of ThailandFullførtBarn med spastisk diplegi, mellom 2 og 10 år | Gross Motor Function Classification System (GMFCS) nivå I, II og IIIThailand