- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07631663
Satiety Evaluation of Mature Okra Flour-incorporated Biscuit (MOFB)
Evaluating the Impact of Mature Okra Flour-Incorporated Biscuits (MOFB) on Perceived Satiety Through the Satiety Labeled Intensity Magnitude (SLIM) Scale and Metabolomic Approach
This study aims to evaluate whether eating biscuits made with mature okra flour can help young adults feel fuller (enhance satiety) and change certain blood markers compared to eating standard biscuits.
Mature okra is a nutrient-dense agricultural by-product that is often discarded due to its tough texture. For this study, mature okra pods are dried and ground into a flour, which is then used to replace 10% of the wheat flour in a custom biscuit formulation.
Participants will take part in a single-blind, randomised trial where they will consume either the okra-incorporated biscuits or the standard control biscuits on separate occasions. Researchers will measure participants' perceived fullness over 165 minutes using a visual rating scale. Blood samples will also be collected at specific intervals during this time to evaluate blood glucose levels, appetite-related hormones, and metabolic responses.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Chee Yee Tan
- Номер телефона: +60134904250
- Электронная почта: cheeyee721@gmail.com
Учебное резервное копирование контактов
- Имя: Mohd Redzwan Sabran, PhD
- Номер телефона: +60397692766
- Электронная почта: mohdredzwan@upm.edu.my
Места учебы
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Selangor
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Serdang, Selangor, Малайзия, 43400
- Рекрутинг
- Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)
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Контакт:
- Chee Yee Tan
- Номер телефона: +60134904250
- Электронная почта: cheeyee721@gmail.com
-
Главный следователь:
- Mohd Redzwan Sabran, PhD
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Младший исследователь:
- Chee Yee Tan
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Young adults aged between 18 and 39 years.
- Normal Body Mass Index (BMI).
Exclusion Criteria:
- Smokers.
- Pregnant or lactating women.
- Individuals with daily medication prescriptions for chronic metabolic conditions, cardiovascular management, or hormonal regulation.
Use of daily medications/supplements that influence appetite regulation, metabolic signalling, or systemic metabolomic profiles, including:
- Hormonal contraceptives, glucocorticoids, and oral/injectable anti-obesity medications (e.g., GLP-1 agonists).
- Antihypertensives and lipid-lowering agents (statins).
- Chronic Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
- Daily fibre supplements.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Mature Okra Flour-incorporated Biscuit (MOFB) Group
Young adult participants assigned to this group will consume the functional biscuit formulation incorporated with mature okra flour.
Perceived satiety, metabolomic profiles, and appetite signalling will be assessed post-ingestion.
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Standard biscuit formulation manufactured where 10% of the wheat flour is substituted with mature okra flour, designed to enhance the nutritional profile while maintaining acceptable sensory scores.
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Активный компаратор: Control Biscuit Group
Young adult participants assigned to this group will consume the standard control biscuit formulation made with 100% wheat flour.
Perceived satiety, metabolomic profiles, and appetite signalling will be assessed post-ingestion.
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Standard biscuit formulation manufactured using 100% wheat flour, designed to match the sensory profile and appearance of the experimental biscuit without the inclusion of mature okra flour.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Satiety Response
Временное ограничение: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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The satiety response after biscuit consumption will be determined by the Satiety Labeled Intensity Magnitude (SLIM) scale.
The SLIM scale consists of a 100mm vertical line with labelled phrases to indicate satiety: "greatest imaginable fullness", "extremely full", "very full", "moderately full", "slightly full", "neither hungry nor full", "slightly hungry", "moderately hungry", "very hungry", and "extremely hungry", and "greatest imaginable hunger".
The first satiety survey is filled before breakfast (time 0), and the remaining surveys at 15, 45, 75, 105, 135 and 165 min later.
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Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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Change in Plasma Insulin Concentration
Временное ограничение: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of insulin will be measured using an enzyme-linked immunosorbent assay (ELISA) kit.
This metric evaluates metabolic responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Active Glucagon-Like Peptide-1 (GLP-1) Concentration
Временное ограничение: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of active GLP-1 will be measured using an enzyme-linked immunosorbent assay (ELISA) kit.
This metric evaluates anorexigenic hormone responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Plasma Peptide YY (PYY3-36) Concentration
Временное ограничение: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of PYY3-36 will be measured using an enzyme-linked immunosorbent assay (ELISA) kit.
This metric evaluates anorexigenic hormone responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Plasma Cholecystokinin (CCK) Concentration
Временное ограничение: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of CCK will be determined using a radioimmunoassay (RIA) kit.
This metric evaluates anorexigenic hormone responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Change in Active Ghrelin Concentration
Временное ограничение: Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Plasma concentration of active ghrelin will be measured using an enzyme-linked immunosorbent assay (ELISA) kit.
This metric evaluates orexigenic hormone responses to the biscuit interventions.
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Fasting state (0 minutes), 75 minutes, and 165 minutes post-consumption
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Changes in Metabolite Profiles
Временное ограничение: Fasting state (0 minutes) and 165 minutes post-consumption
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For metabolomic analysis, the blood samples will be taken in the fasting state (0 min) and after the last satiety survey (165 min).
Metabolites will be quantified by Liquid Chromatography-Mass Spectrometry (LC-MS) analysis, and the serum samples will be prepared according to In Vitro Diagnostics Research (IVDr) standard operating procedures.
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Fasting state (0 minutes) and 165 minutes post-consumption
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Blood Glucose Response
Временное ограничение: Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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The capillary blood glucose will be measured using the finger-prick method during the fasting state (time 0), and at 15, 45, 75, 105, 135 and 165 min later.
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Baseline (0 minutes) and post-consumption at 15, 45, 75, 105, 135, and 165 minutes
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Ad Libitum Energy Intake at a Subsequent Meal
Временное ограничение: At the end of the satiety evaluation session (165 minutes post-biscuit consumption)
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Following the 165-minute satiety evaluation session, participants will be served an ad libitum meal consisting of fried rice and requested to consume as much as they want until comfortably full.
The weight of the food consumed will be calculated by subtracting the remaining food weight from the initial served weight using a digital weighing scale (accurate to 1.0 g).
Total energy intake will be calculated by multiplying the weight of the food consumed by the specific caloric content of the fried rice (expressed in kilocalories).
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At the end of the satiety evaluation session (165 minutes post-biscuit consumption)
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Mohd Redzwan Sabran, PhD, Universiti Putra Malaysia
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
Другие идентификационные номера исследования
- JKEUPM-2025-1085
- GP-IPS/2024/9813100 (Другой номер гранта/финансирования: Universiti Putra Malaysia)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
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. .