- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02763371
Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) (CogniDo-GI)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Dortmund, 독일, 44225
- 모병
- Germany Research Institute of Child Nutrition
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연락하다:
- Mathilde Kersting, Professor
- 전화번호: 023179221018
- 이메일: kersting@fke-do.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Shifting: Change of total reaction time for a) [ms]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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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
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Shifting: Change of total reaction time for b) [ms
기간: 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
기간: 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
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updating: change of ratio of missing [%]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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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.
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participants were tested on two test days (T1 and T2) with one week wash out
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updating: change of ratio of false alarms [%]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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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.
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participants were tested on two test days (T1 and T2) with one week wash out
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updating: change of mean reaction time [ms]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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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.
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participants were tested on two test days (T1 and T2) with one week wash out
|
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tonic alertness: change of mean reaction time [ms]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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measures the level of alertness in response to a simple visual stimulus.
Mean reaction time
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participants were tested on two test days (T1 and T2) with one week wash out
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tonic alertness: change of deviation of reaction time [ms]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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measures the level of alertness in response to a simple visual stimulus.
Deviation of reaction time
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participants were tested on two test days (T1 and T2) with one week wash out
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tonic alertness:change of numbers of omission errors [n]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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measures the level of alertness in response to a simple visual stimulus.
subsidiary outcome is the numbers of omission errors.
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participants were tested on two test days (T1 and T2) with one week wash out
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tonic alertness:change of numbers of commission errors [n]
기간: participants were tested on two test days (T1 and T2) with one week wash out
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measures the level of alertness in response to a simple visual stimulus.
subsidiary outcome is the numbers of comission errors.
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participants were tested on two test days (T1 and T2) with one week wash out
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공동 작업자 및 조사자
수사관
- 연구 의자: Mathilde Kersting, Prof, Research Institut of Child Nutrition
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- COG0416DO
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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