- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03917810
Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure
Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.
Each participant will undergo 3 days of each diet:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Обзор исследования
Подробное описание
Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.
It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.
Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.
This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:
- Moderate sugar - reflecting the composition of a typical European diet
- Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
- Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Somerset
-
Bath, Somerset, Соединенное Королевство, BA2 7AY
- University of Bath
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Body mass index 18.5-29.9 kg∙m-2
- Age 18-65 years
- Male
- Able and willing to provide informed consent and safely comply with study procedures
- No anticipated changes in physical activity during the study (e.g. holidays)
Exclusion Criteria:
- Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
- Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
- Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
- Any reported recent (<6 months) change in body mass (±3%)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: MODSUG
Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
|
Состав макронутриентов (в частности, тип и/или количество углеводов) регулируется
|
|
Экспериментальный: LOWSUG
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
|
Состав макронутриентов (в частности, тип и/или количество углеводов) регулируется
|
|
Экспериментальный: LOWCHO
Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
|
Состав макронутриентов (в частности, тип и/или количество углеводов) регулируется
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Physical activity energy expenditure (kj/day or kcal/day)
Временное ограничение: 3 days
|
Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
|
3 days
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time spent in different physical activity intensities (MET categories) (minutes)
Временное ограничение: 3 days
|
Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry
|
3 days
|
|
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
Временное ограничение: 3 days
|
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry
|
3 days
|
|
Energy expended in the postprandial period (kJ or kcal)
Временное ограничение: 3 days
|
Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry
|
3 days
|
|
Fasting blood glucose concentrations
Временное ограничение: 3 days
|
Measures of blood glucose concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood insulin concentrations
Временное ограничение: 3 days
|
Measures of blood insulin concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood triglyceride concentrations
Временное ограничение: 3 days
|
Measures of blood triglyceride concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood non-esterified fatty acid concentrations
Временное ограничение: 3 days
|
Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood lactate concentrations
Временное ограничение: 3 days
|
Measures of blood lactate concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood beta-hydroxybutyrate concentrations
Временное ограничение: 3 days
|
Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood leptin concentrations
Временное ограничение: 3 days
|
Measures of blood leptin concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood fibroblast growth factor-21 concentrations
Временное ограничение: 3 days
|
Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood total cholesterol concentrations
Временное ограничение: 3 days
|
Measures of blood total cholesterol concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood high density lipoprotein concentrations
Временное ограничение: 3 days
|
Measures of blood high density lipoprotein concentrations pre- and post-intervention.
|
3 days
|
|
Fasting blood low density lipoprotein concentrations
Временное ограничение: 3 days
|
Measures of blood low density lipoprotein concentrations pre- and post-intervention.
|
3 days
|
|
Food preference ratings
Временное ограничение: 3 days
|
Food preference ratings determined by computer task measured pre- and post-intervention
|
3 days
|
|
Subjective appetite and mood ratings
Временное ограничение: 3 days
|
Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
|
3 days
|
|
Blood pressure
Временное ограничение: 3 days
|
Blood pressure using an automated sphygmomanometer pre- and post-intervention
|
3 days
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Betts JA, Richardson JD, Chowdhury EA, Holman GD, Tsintzas K, Thompson D. The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults. Am J Clin Nutr. 2014 Aug;100(2):539-47. doi: 10.3945/ajcn.114.083402. Epub 2014 Jun 4.
- Smith HA, Gonzalez JT, Thompson D, Betts JA. Dietary carbohydrates, components of energy balance, and associated health outcomes. Nutr Rev. 2017 Oct 1;75(10):783-797. doi: 10.1093/nutrit/nux045.
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
Ключевые слова
Другие идентификационные номера исследования
- EP 17/18 219
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. .