- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03643315
Determinants of Post-Exercise Eating Patterns (DEEP)
Determinants of Post-Exercise Eating Patterns / Alternative Title (Cover): Effect of Pre-meal Activities on Blood Pressure in Healthy Adults
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Singapore, Сингапур, Singapore 11760
- Рекрутинг
- Clinical Nutrition Research Centre
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Контакт:
- Aaron Sim, PhD
- Номер телефона: 64074046
- Электронная почта: aaron_sim@sics.a-star.edu.sg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Male
- Inactive (< 90 min of moderate-intensity exercise a week)
- BMI: 23 and above
- Age between 21 to 40 years
- Normal fasting blood glucose levels equal to or less than 5.9 mmol/L
- Non-smoker
- No know allergies or intolerance to food
- Not on any prescribed medication
- No physical disabilities and/or restrictions; not averse to exercising on a stationary bike or treadmill running
- No aversion to blood sampling procedures (e.g. finger prick, cannulation)
Exclusion Criteria:
- Female,
- Smoker,
- Fasting blood glucose > 5.9 mmol/L,
- Resting blood pressure > 140/90 mmHg,
Any major medical/health conditions including
- Diabetes,
- Metabolic disease
- Hypertension,
- Cardiovascular disease,
- Thyroid disorders,
- G6PD deficiency.
- Allergic or intolerant to foods presented in the study.
- Physical disabilities and/or restrictions.
- Individuals that are adverse to exercising on a stationary exercise bike or treadmill.
- Adverse to blood sampling procedures (i.e. cannulation, finger pricks, venepuncture).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Exercise and Meal (EX)
The EX protocol will involve a 30 minute acute bout of high intensity intermittent exercise on a stationary exercise bike followed by an ad-libitum test meal.
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30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
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Экспериментальный: No-Exercise and Meal (NEX)
The NEX protocol will involve a 30 minute period of rest (to match the exercise period in EX) where participants will be provided a video/movie.
Following this, participants will be provided ad-libitum access to a test meal (as per EX energy intake assessment protocol)
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30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Ad-libitum amount of food consumed in response to experimental condition: exercise or rest (no exercise).
Временное ограничение: 3 hours
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Participants' eating behaviour will be assessed by measuring the total amount of the test meal consumed in each experimental condition.
The test meal will be provided ad-libitum (i.e.
there will be non-restricted access)
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3 hours
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Appetite-related blood hormone concentration in response to experimental conditions.
Временное ограничение: 3 hours
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Venous blood will be sampled for the measurement of a range of appetite-related hormones including Active Ghrelin (pg/ml), Glucagon-like Peptide-1 (GLP-1) (pg/ml), Pancreatic YY (PYY) (pg/ml), Pancreatic Polypeptide (PP) (pg/ml), periodically through the experimental sessions.
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3 hours
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Metabolic blood variable concentration in response to experimental conditions
Временное ограничение: 3 hours
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Venous blood will be sampled for the measurement of metabolic blood variables blood insulin (mmol/L) and blood glucose (mmol/L) periodically through the experimental sessions.
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3 hours
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Subjective ratings of hunger in response to experimental conditions
Временное ограничение: 3 hours
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Self-reported subjective ratings of hunger will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales.
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3 hours
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Subjective ratings of satiation (fullness) in response to experimental conditions
Временное ограничение: 3 hours
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Self-reported subjective ratings of satiation (fullness) will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales
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3 hours
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Subjective ratings of desire to eat in response to experimental conditions
Временное ограничение: 3 hours
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Self-reported subjective ratings of desire to eat will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales
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3 hours
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Subjective ratings of prospective food consumption in response to experimental conditions
Временное ограничение: 3 hours
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Self-reported subjective ratings of prospective food consumption will be assessed periodically through the experimental session.
Assessed via 100-point visual analogue scales.
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3 hours
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Free-living energy intake (1 day post-experiment) in response to experimental conditions
Временное ограничение: 1 day
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1 day free-living energy intake (self-report)
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1 day
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Free-living physical activity levels intake (1 day post-experiment) in response to experimental conditions
Временное ограничение: 1 day
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1 day free-living physical activity levels (physical activity monitors)
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1 day
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Self-reported tendencies of compensatory health beliefs
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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Influence of self-reported tendencies of compensatory health beliefs on the relationship between experimental conditions and study outcomes. Scale to be used: Compensatory Health Belief (CHB) Scale, CHB Subscales: Substance use, Eating/sleeping habits, Stress and Weight regulation, Ratings on a 5-point agreement scale. Greater scores (summed) indicate greater tendency for an individual to hold compensatory beliefs (for the particular domain/subscale or collectively). |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported tendencies of licensing/reward beliefs
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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Influence of self-reported tendencies of licensing eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes. Scale to be used: Post-Exercise Licensing (PEL)Scale. Ratings on a 7 point agreement scale. Greater scores (averaged) indicate a greater tendency to reward/license in response to exercise. |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported tendencies and motives of compensatory eating behaviour in response to exercise
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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Influence of self-reported tendencies and motives of compensatory eating behaviour in response to exercise on the relationship between experimental conditions and study outcomes Scale to be used: Compensatory Eating Motives Questionnaire (CEMQ) Subscales: Eating for Reward, Eating for Recovery, Eating for Relief (4 point frequency scale) Greater scores (summation of outcome of respective subscales) indicate greater tendency to compensate due to particular motive (respective subscales). |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported assessment of motivation (regulation) to exercise
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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To examine the influence of self-reported motivation to exercise on the relationship between experimental conditions and study outcomes. Scale involve: Behavioural Regulation in Exercise Questionnaire (BREQ) measures the stages of the self-determination contin. Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for exercise behaviour to be regulated by particular construct (respective subscale). |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported assessment of motivation to eat healthily
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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To examine the influence of self-reported motivation to adopt healthy eating behaviour on the relationship between experimental conditions and study outcomes. Scale involve: Regulation of Eating Behavioural Scale (REBS). Subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation. Greater scores (averaged of outcome of respective subscale/items) indicate greater tendency for eating behaviour to be regulated by particular construct (respective subscale). |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported attitudes towards eating behaviour as assessed by the Three Factor Eating Behaviour Questionnaire (TFEQ-R18)
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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Influence of self-reported attitudes towards eating on the relationship between experimental conditions and study outcomes. Scale involve: Three Factor Eating Behaviour Questionnaire (TFEQ-R18) Subscales: Dietary Restraint, Uncontrolled Eating, Emotional Eating Greater scores (averaged outcome of respective subscale/items) indicate greater likelihood of the behaviour (of construct measure by respective subscales). |
Assessed at start of study - through study completion - up to 4-5 weeks
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Self-reported weight-related behaviour change status as assessed by the Physical Activity Stages of Change Questionnaire
Временное ограничение: Assessed at start of study - through study completion - up to 4-5 weeks
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Influence of self-reported weight-related behaviour change status on the relationship between experimental conditions and study outcomes. Scale involve: Physical Activity Stages of Change Questionnaire. Scores (based on scoring algorithm) will indicate participants' current stage of motivational readiness for change specific to physical activity. Greater score (1-5 representing five stages of change) indicates physical activity status and intent to be active. |
Assessed at start of study - through study completion - up to 4-5 weeks
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
Ключевые слова
Другие идентификационные номера исследования
- 2017/01034
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF)
Will be made available to other researchers upon request
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. .
Клинические исследования Exercise and Meal (EX)
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University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityЗавершенныйДетское ожирениеФранция