- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02763371
Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) (CogniDo-GI)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Dortmund, Alemanha, 44225
- Recrutamento
- Germany Research Institute of Child Nutrition
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Contato:
- Mathilde Kersting, Professor
- Número de telefone: 023179221018
- E-mail: kersting@fke-do.de
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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.
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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.
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Experimental: 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.
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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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Shifting: Change of total reaction time for a) [ms]
Prazo: 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
Prazo: 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
Prazo: 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 [%]
Prazo: 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 [%]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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]
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Mathilde Kersting, Prof, Research Institut of Child Nutrition
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- COG0416DO
Plano para dados de participantes individuais (IPD)
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