The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
The Acute Effects of Fortified Nutritional Supplementation on Cognition, Memory, & Achievement
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Regular breakfast consumption is linked to improved cognitive performance in school-aged children. However, the acute benefits of defined nutrient consumption on brain and cognitive health are not well understood, particularly in preadolescent children. One factor that may relate to brain health and learning in children is the contribution of carbohydrates to the digestion rate of a meal (and associated effects on post-prandial glycemia).
The effects of differentially absorbed carbohydrates on brain and cognition are unknown, especially when ingested via a fortified nutritional beverage providing a balanced array of nutrients. The aim of this study is to investigate the acute, transient effect of nutrient supplementation with varied carbohydrate systems in preadolescent children (i.e., 9-10 years).
Participants will be randomized to receive one of three treatment nutritional formulations containing carbohydrates with varying absorption rates along with a non-caloric placebo. Participants will perform a cognitive battery in the fasted condition, shortly after treatment ingestion, and an hour after ingestion. Group differences in performance will be contrasted to assess the effects of different carbohydrate types on children's cognitive function following an overnight fast.
Findings from this study will inform our understanding of the macronutrient profile of breakfast that may potentially improve children's cognitive performance in the morning.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Illinois
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Urbana, Illinois, Соединенные Штаты, 61801
- Department of Kinesiology and Community Health
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Parental/guardian consent.
- Participants must be between the ages of 9-10 years old at the time of testing age
- Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- Participants must have an IQ > 85 (IQ < 85).
Exclusion Criteria:
- Prior diagnosis of cognitive or physical disability, including ADHD (severe asthma, epilepsy, and dependence upon a wheelchair/walking aid, and ADHD Rating Scale score below 85%).
- Use of anti-psychotic, anti-depressant, anti-anxiety medication, as well as those medications used for ADD/ADHD (use of any anti-psychotic, anti-depressant, anti-anxiety, and ADD/ADHD medications).
- Early pubertal status, as measured by a modified test of the Tanner Staging System (onset of puberty as determined by Tanner).
- Lactose intolerance
- Allergies to milk and/or soy
- Adherence to a strict vegan diet
Учебный план
Как устроено исследование?
Детали дизайна
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: SLOW Carbohydrate
Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response.
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Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
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Экспериментальный: MEDIUM Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response.
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Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
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Экспериментальный: FAST Carbohydrate
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response.
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Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
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Плацебо Компаратор: Non-Caloric Placebo
Non-caloric placebo consisting of artificial sweeteners
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Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Cognitive Control at 15 minutes Postprandial
Временное ограничение: 15 minutes Postprandial
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Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 15 minutes and baseline/fasted (within 2 hours of wake-time) performance.
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15 minutes Postprandial
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Change in Cognitive Control at 70 minutes Postprandial
Временное ограничение: 70 minutes Postprandial
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Performance will be assessed using the difference in inverse efficiency (during a modified flanker task) between performance at 70 minutes and baseline/fasted (within 2 hours of wake-time).
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70 minutes Postprandial
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Relational Memory at 30 minutes Postprandial
Временное ограничение: 30 minutes Postprandial
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Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 30 minutes postprandial.
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30 minutes Postprandial
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Change in Relational Memory at 85 minutes Postprandial
Временное ограничение: 85 minutes Postprandial
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Performance will be assessed using the difference in number of swap errors (during a spatial reconstruction task) by calculating the difference between number of errors performed at baseline/fasted (within 2 hours of wake-time) from number of errors at 85 minutes postprandial.
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85 minutes Postprandial
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Charles Hillman, PhD, University of Illinois at Urbana-Champaign
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 12641
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования SLOW Carbohydrate
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