- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07932769
Effect of Meal Sequence and Eating Speed on Blood Glucose After Eating Western Breakfast Among Healthy Young Adults
Impact of Meal Sequence and Eating Speed on Postprandial Glycemic Response of an Isocaloric Western Breakfast Among Healthy Young Adults
The goal of this clinical trial is to investigate the effects of meal sequence(the order in which carbohydrates/starches and non-starchy vegetables are consumed) and eating speed(slow or fast) on postprandial blood glucose response in healthy young adults (n=22) aged 20-25 years. The main questions it aims to answer are:
- Does consuming carbohydrate-containing foods before or after non-starchy vegetables influence postprandial blood glucose response?
- Does eating a standardized breakfast slowly (over approximately 20 minutes) or quickly (over approximately 10 minutes) affect postprandial blood glucose response?
- Do meal sequence and eating speed together influence postprandial glycemic response? Researchers will compare four breakfast conditions combining two meal sequences (carbohydrate-first and non-starchy vegetable-first) with two eating speeds (slow and fast) to determine their individual and combined effects on postprandial metabolic responses.
Participants will:
- Consume a standardized, isocaloric Western-style breakfast under four different experimental conditions.
- Consume the breakfast in the assigned food order and within the specified eating duration during each experimental visit.
- Attend four experimental visits in a randomized order, with a washout period between visits.
- Provide blood samples before and at 30, 60, 90, and 120 minutes after breakfast consumption to assess blood glucose levels.
- Undergo assessment of serum insulin and triglyceride responses according to the study protocol.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Humaira Ashraf, M.Phil food & nutrition
- Номер телефона: +92 3356312424
- Электронная почта: humairaashraf602@gmail.com
Места учебы
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Punjab Province
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Lahore, Punjab Province, Пакистан
- University of Veterinary and Animal Sciences, Paksitan
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Контакт:
- Sanaullah Iqbal Associate Professor, FSHN,UVAS
- Номер телефона: +923338981489
- Электронная почта: sanaullah.iqbal@uvas.edu.pk
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Контакт:
- Humaira Ashraf M.phil Food and Nutrition
- Номер телефона: +923356312424
- Электронная почта: humairaashraf602@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
Healthy male adults aged 18-25 years, with a BMI of 18.0-24.9 kg/m², without known diseases, regular medication use, or allergies to study food ingredients.
Exclusion Criteria:
Individuals with diabetes or other diagnosed diseases, those using medications, following specific diets, or having dietary restrictions or allergies to study food ingredients will be excluded.
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 |
|---|---|
|
Экспериментальный: Sequence 1: A-B-D-C
Arm 1 - Sequence 1 (A-B-D-C): A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the sequence as :carbohydrate-first with slow eating, carbohydrate-first with fast eating, vegetable-first with fast eating, and vegetable-first with slow eating, in that order, over four weekly visits. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
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Экспериментальный: Sequence 2: B-C-A-D
Arm 2: Sequence 2 (B-C-A-D) A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Experimental arm. Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the following order: carbohydrate-first with fast eating, vegetable-first with slow eating, carbohydrate-first with slow eating, and vegetable-first with fast eating. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
|
Экспериментальный: Sequence 3: C-D-B-A
Arm 3 - Sequence 3 (C-D-B-A): A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables, in the sequence as: vegetable-first with slow eating, vegetable-first with fast eating, carbohydrate-first with fast eating, and carbohydrate-first with slow eating, in that order, over four weekly visits. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
|
Экспериментальный: Sequence 4: D-A-C-B A:
Arm 4: Sequence 4 (D-A-C-B) Experimental arm: A: Carbohydrate-first + slow eating (20 minutes); B: Carbohydrate-first + fast eating (10 minutes) ; C: Vegetable-first + slow eating (20 minutes) ; D: Vegetable-first + fast eating (10 minutes). Participants receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables in the following order: vegetable-first with fast eating, carbohydrate-first with slow eating, vegetable-first with slow eating, and carbohydrate-first with fast eating. |
Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of the standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the carbohydrate-containing portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed slowly over approximately 20 minutes. Participants will receive an Isocaloric breakfast containg toasted white bread, scrambled eggs and stir fired non-starchy vegetables. Participants will consume the non-starchy vegetable portion of a standardized, isocaloric Western-style breakfast first, followed by the remaining meal components. The entire breakfast is to be consumed quickly over approximately 10 minutes. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Postprandial Blood Glucose Incremental Area Under the Curve (iAUC) from 0 to 120 Minutes Across Four Breakfast Conditions
Временное ограничение: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each of the four intervention visits (approximately 4 weeks).
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Measurement details: Blood glucose concentrations measured at baseline (0 minutes) and 30, 60, 90, and 120 minutes after breakfast consumption. The incremental area under the curve (iAUC) will be calculated to compare postprandial glycemic responses across the four conditions. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each of the four intervention visits (approximately 4 weeks).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Postprandial Serum Insulin Response Across Four Breakfast Conditions.
Временное ограничение: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Serum insulin concentrations will be assessed following consumption of each breakfast condition to evaluate differences in postprandial insulin responses associated with meal sequence and eating speed. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
|
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Postprandial Serum Triglyceride Response Across Four Breakfast Conditions
Временное ограничение: At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Serum triglyceride concentrations will be assessed following consumption of each breakfast condition to compare postprandial lipid responses associated with meal sequence and eating speed. |
At baseline and 30, 60, 90, and 120 minutes after breakfast consumption during each intervention visit.
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
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
Ключевые слова
Другие идентификационные номера исследования
- MealSequence-GlycemicResponse
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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