Influence of Tea Consumption on Human Glycemic Response
Обзор исследования
Статус
Условия
Подробное описание
This study aims to investigate the effects of tea and food consumption on postprandial metabolic responses, specifically focusing on blood glucose (glycemia) and blood lipid levels. The primary objective is to generate scientifically grounded insights that can inform consumer education and product communication regarding the metabolic impacts of tea and food intake. The study will recruit healthy male volunteers of Chinese ethnicity, aged 21 to 60 years inclusive. Eligible participants will be required to attend seven study visits: (1) an initial screening session, (2) a 2-hour Oral Glucose Tolerance Test (OGTT), and (3-7) five 3-hour intervention sessions.
During the screening, participants will undergo body composition measurement, and a blood draw to confirm eligibility. Participants will also be provided with standardized dinner meals to be consumed the day before each subsequent visits as their last meal of the day before an overnight fast. In the OGTT session, participants will fast overnight. They will be cannulated and consume a glucose beverage; blood samples will be collected at seven timepoints over two hours to analyze for glucose, insulin, lipids, and other metabolic biomarkers. Each of the five intervention sessions will also require overnight fasting. Participants will consume either: one of two tea beverages, each tea beverage with a standardized meal, or the meal alone. Participants will be cannulated and blood will be drawn at nine timepoints over three hours per session. They will also complete satiety questionnaires at each timepoint. Blood samples will be analyzed for glucose, insulin, lipid panel, hormones, and other metabolic biomarkers to evaluate the postprandial effects of the interventions.
The findings are expected to clarify whether tea modulates postprandial glycemic and lipid responses compared to typical intake conditions. Results may support evidence-based communication about tea's metabolic effects and inform future product development and consumer guidance.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Singapore, Сингапур
- National University of Singapore, Department of Food Science & Technology
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Male
- Chinese ethnicity
- Ages 21-60 years old (inclusive)
- Healthy
- Weigh at least 50kg
- Must be English-literate and able to give informed consent in English
- Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria:
- Female
- A current smoker, or has smoked in the past 2 years
- Fasting glucose >= 7 mmol/L
- History of type 1/type 2 diabetes
- Regular use of medication that may affect glucose metabolism (e.g., steroids)
- Being diagnosed with cancer, heart disease, stroke, renal failure, serious mental or physical illnesses at the time of recruitment
- History of food allergies to test products (milk tea) i.e. milk allergies, or lactose intolerance
- History of food allergies to any of the ready made meals (such as soy, peanuts, eggs, shellfish etc)
- Have donated blood of more than 500 mL within 8 weeks of study enrolment
- Any other conditions, which, in the opinion of the Investigator would make the subject unsuitable for inclusion or could interfere with the subject participating in or completing the study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Tea Type #1
In this intervention, participants will be cannulated and required to consume a specific tea beverage #1.
Blood will be drawn through the cannula at 9 different timepoints (0, 15, 30, 45, 60, 90, 120, 150, 180 min) to test for glucose, insulin, lipids, and other metabolic biomarkers.
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This is a specific tea variety #1 that will be consumed by participants.
It contains milk, a small amount of sugar, and will be served cold with ice.
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Экспериментальный: Tea Type #2
In this intervention, participants will be cannulated and required to consume a specific tea beverage #2.
Blood will be drawn through the cannula at 9 different timepoints (0, 15, 30, 45, 60, 90, 120, 150, 180 min) to test for glucose, insulin, lipids, and other metabolic biomarkers.
|
This is a specific tea variety #1 that will be consumed by participants.
It contains milk, a small amount of sugar, and will be served cold with ice.
|
|
Экспериментальный: Tea Type #1 + Standardized Meal
In this intervention, participants will be cannulated and required to consume a specific tea beverage #1 and a standardized meal.
Blood will be drawn through the cannula at 9 different timepoints (0, 15, 30, 45, 60, 90, 120, 150, 180 min) to test for glucose, insulin, lipids, and other metabolic biomarkers.
|
This is a specific tea variety #1 that will be consumed by participants.
It contains milk, a small amount of sugar, and will be served cold with ice.
This is a ready to eat meal that can be purchased off the shelves in local stores.
The same meal is used for several study arms to serve as a standardization on the nutritional content consumed.
|
|
Экспериментальный: Tea Type #2 + Standardized Meal
In this intervention, participants will be cannulated and required to consume a specific tea beverage #2 and a standardized meal.
Blood will be drawn through the cannula at 9 different timepoints (0, 15, 30, 45, 60, 90, 120, 150, 180 min) to test for glucose, insulin, lipids, and other metabolic biomarkers.
|
This is a specific tea variety #1 that will be consumed by participants.
It contains milk, a small amount of sugar, and will be served cold with ice.
This is a ready to eat meal that can be purchased off the shelves in local stores.
The same meal is used for several study arms to serve as a standardization on the nutritional content consumed.
|
|
Экспериментальный: Standardized Meal
In this intervention, participants will be cannulated and required to consume a standardized meal.
Blood will be drawn through the cannula at 9 different timepoints (0, 15, 30, 45, 60, 90, 120, 150, 180 min) to test for glucose, insulin, lipids, and other metabolic biomarkers.
|
This is a ready to eat meal that can be purchased off the shelves in local stores.
The same meal is used for several study arms to serve as a standardization on the nutritional content consumed.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Changes in laboratory analysis of blood glucose and insulin measurements at 9 timepoints over 3 hours for each session
Временное ограничение: Approximately 16 weeks from enrolment to the end of study
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Approximately 16 weeks from enrolment to the end of study
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Mei Hui Liu, PhD, National University of Singapore
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
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
- NUS-IRB-2025-906
Планирование данных отдельных участников (IPD)
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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.
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