- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07611877
Ecklonia Cava Supplementation and Cycling Performance
Acute Ecklonia Cava Supplementation Fails to Enhance Performance in Trained Cyclists
The goal of this clinical trial (randomised, double-blind, placebo-controlled crossover study) is to investigate whether supplementation with Ecklonia cava, a natural extract derived from brown seaweed, affects exercise performance and physiological responses in trained cyclists.
The main questions it aims to answer are:
Does Ecklonia cava supplementation improve cycling performance, including power output during steady-state exercise and short maximal sprints? Does Ecklonia cava supplementation influence physiological responses to exercise, such as blood glucose, blood lactate, heart rate, and oxygen consumption?
Researchers will compare Ecklonia cava supplementation to a placebo (a look-alike substance with no active ingredients) to determine whether the supplement has any effect on performance or physiological responses.
In this crossover design, all participants will receive both the Ecklonia cava supplement and the placebo on separate occasions, with a washout period between conditions.
Participants will:
Ingest either Ecklonia cava or a placebo 30 minutes before exercise testing Complete a 60-minute cycling protocol at a moderate intensity Perform repeated short-duration maximal sprint efforts following the steady-state exercise Attend laboratory testing sessions under both supplement and placebo conditions Undergo measurements of physiological responses, including blood glucose, blood lactate, heart rate, oxygen consumption, and respiratory exchange ratio Have exercise performance assessed through measures of power output during cycling
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
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Kingston upon Thames, Соединенное Королевство, KT1 2EE
- Department of Applied and Human Sciences
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- experienced in cycling (defined as completing at least four hours of cycle training per week with a minimum of two years of experience)
Exclusion Criteria:
- Smoker
- cardiovascular disease
- anti-hypertensive medication
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Добавка плацебо
|
Placebo Supplementation
|
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Экспериментальный: Ecklonia Cava Supplementation
|
Ecklonia Cava Supplementation
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Peak Power Output During Sprint Performance (Watts)
Временное ограничение: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Peak power output achieved during 20-second maximal sprint efforts performed following a fixed-intensity (55% Wmax) 60-minute cycling protocol
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Mean Power Output During Sprint Performance (Watts)
Временное ограничение: Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Mean power output recorded during repeated 20-second maximal sprint efforts following steady-state cycling
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Immediately after the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Blood Lactate Concentration During Sprint Cycling (mmol/L)
Временное ограничение: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
Blood lactate concentration measured following each repeated sprint efforts (3)
|
Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
|
Blood Glucose Concentration During Sprint Cycling (mmol/L)
Временное ограничение: Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
Blood glucose concentration measured following repeated sprint efforts
|
Repeated sprint cycling (3) completed immediately after the 60-minute submaximal cycling protocol, a blood sample taken 2 minutes after each sprint cycling bout. Following each 30-minute supplementation protocol.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Heart Rate During Submaximal Cycling (beats per minute)
Временное ограничение: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
|
Average heart rate measured during a 60-minute steady-state cycling protocol performed at 55% maximal power output
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation (each condition)
|
|
Blood Lactate Concentration During Submaximal Cycling (mmol/L)
Временное ограничение: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Blood lactate concentration measured during steady-state cycling at 55% maximal power output
|
Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Blood Glucose Concentration During Submaximal Cycling (mmol/L)
Временное ограничение: Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Blood glucose concentration measured during steady-state cycling at 55% maximal power output
|
Every 20-minutes during the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
|
Oxygen Consumption (VO₂) During Submaximal Cycling (ml/kg/min)
Временное ограничение: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Oxygen consumption measured using indirect calorimetry during steady-state cycling
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory Exchange Ratio (RER) During Submaximal Cycling
Временное ограничение: During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
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Respiratory exchange ratio measured during steady-state cycling using expired gas analysis
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During the 60-minute submaximal cycling protocol, 30 minutes after supplementation
|
Соавторы и исследователи
Спонсор
Соавторы
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1501 (CSL Behring)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .