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Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) (CogniDo-GI)

3. května 2016 aktualizováno: Research Institute of Child Nutrition, Dortmund
The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The The Cognition Intervention Study Dortmund Continued (Coco) connected this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon. The present study the Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) examines the influence of the gylcemic index of lunch on cognitive performance of school children in the afternoon.

Přehled studie

Detailní popis

Glucose is the main fuel of the human brain. However, which impact the glycemic index of lunch has on cognitive performance is not clear. A recently published review by Philippou and Constantinou suggested cautiously that a low-GI meal may favor cognitive functions in adults, but note that their findings are inconclusive due to differences in study design, study sample (e.g. size, age), time of testing and the cognitive domain being examined. Because of cerebral particularities, children may react highly sensitive to variations of glycose supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school.

As prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the mid-morning is standardized. The intervention is integrated in everyday school life: 9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. lunch with a high GI-rice or a low GI-rice and a water beverage, 12.45 p.m. to 13.15 p.m. regular lunch break, 13.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning.

Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.

Typ studie

Intervenční

Zápis (Očekávaný)

200

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Dortmund, Německo, 44225
        • Nábor
        • Germany Research Institute of Child Nutrition
        • Kontakt:
          • Mathilde Kersting, Professor
          • Telefonní číslo: 023179221018
          • E-mail: kersting@fke-do.de

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

10 let až 14 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • all fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child

Exclusion Criteria:

  • Metabolic diseases or special diet

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Dietary: high GI lunch
High GI-rice lunch ad libitum on test day 1 and low GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
High GI: High-GI rice lunch ad libitum on test day 1 and low GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
Experimentální: Dietary: low GI lunch
Low GI-rice lunch ad libitum on test day 1 and high GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
Low-GI: Low GI-rice lunch ad libitum on test day 1 and high GI-rice lunch on test day 2. Water at libitum was constantly available on both days.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Shifting: Change of total reaction time for a) [ms]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out

Measuring global task-switching costs by a three-part computer trial.

a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

participants were tested on two test days (T1 and T2) with one week wash out
Shifting: Change of total reaction time for b) [ms
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out

Measuring global task-switching costs by a three-part computer trial.

a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

participants were tested on two test days (T1 and T2) with one week wash out
Shifting: Change of total switch-costs [ms
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out

Measuring global task-switching costs by a three-part computer trial.

a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

participants were tested on two test days (T1 and T2) with one week wash out
updating: change of ratio of missing [%]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
participants were tested on two test days (T1 and T2) with one week wash out
updating: change of ratio of false alarms [%]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
participants were tested on two test days (T1 and T2) with one week wash out
updating: change of mean reaction time [ms]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
participants were tested on two test days (T1 and T2) with one week wash out
tonic alertness: change of mean reaction time [ms]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. Mean reaction time
participants were tested on two test days (T1 and T2) with one week wash out
tonic alertness: change of deviation of reaction time [ms]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. Deviation of reaction time
participants were tested on two test days (T1 and T2) with one week wash out
tonic alertness:change of numbers of omission errors [n]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of omission errors.
participants were tested on two test days (T1 and T2) with one week wash out
tonic alertness:change of numbers of commission errors [n]
Časové okno: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of comission errors.
participants were tested on two test days (T1 and T2) with one week wash out

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Studijní židle: Mathilde Kersting, Prof, Research Institut of Child Nutrition

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2016

Primární dokončení (Očekávaný)

1. června 2016

Dokončení studie (Očekávaný)

1. prosince 2016

Termíny zápisu do studia

První předloženo

28. dubna 2016

První předloženo, které splnilo kritéria kontroly kvality

3. května 2016

První zveřejněno (Odhad)

5. května 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

5. května 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. května 2016

Naposledy ověřeno

1. května 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • COG0416DO

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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