Variation in the Impact of Coffee on the Metabolic Rate
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Caffeine content.
- Кому может быть актуально
- Состояния в реестре: Healthy. Базовые параметры: 18 лет — 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female.
Подробное описание
The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS).
Вмешательства
- Другое Caffeine content
Participants will drink the same volume of coffee with different amounts of caffeine.
Первичные конечные точки
- Resting energy expenditure [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Urine metabolites [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Expired gases [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
Вторичные конечные точки (11)
- Body temperature [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Electrocardiogram (ECG) [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Blood samples [Срок оценки: Baseline : empty stomach On the first moring of experiment.]
- Blood pressure [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Height [Срок оценки: On the first moring of experiment, it lasts 5 minutes.]
- Body weight [Срок оценки: On the first moring of experiment, it lasts 5 minutes.]
- Fat mass [Срок оценки: On the second moring of experiment, it lasts 10 minutes.]
- Fat free mass [Срок оценки: On the first moring of experiment, it lasts 5 minutes.]
- Bone mass [Срок оценки: On the first moring of experiment, it lasts 10 minutes.]
- Heart rate [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
- Body water, extracellular fluid and intracelluar fluid [Срок оценки: On the first moring of experiment, it lasts 0.5 hours and 3 hours.]
Критерии участия
Критерии включения
Healthy adults 18-40 years old
Критерии исключения
Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc.
People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc.
Those who have recently lost weight for various medical reasons ( like cancer, etc.).
People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Фундаментальное исследование
Центры проведения
Китай · 1 центр
- Shenzhen Institute of Advanced Technology — Шэньчжэнь
Идентификаторы
NCT: NCT06432504 · SIAT IRB 221115H0629