- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02763371
Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) (CogniDo-GI)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
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
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
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
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
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
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
Vyšetřovatelé
- Studijní židle: Mathilde Kersting, Prof, Research Institut of Child Nutrition
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
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)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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 .
Klinické studie na Kognitivní funkce
-
Incyte CorporationDostupnýSTAT1 Gain-of-Function Disease
-
Faeth TherapeuticsUkončenoPokročilý pevný nádor | Mutace PIK3CA | PTEN Loss of Function MutationSpojené státy