Меню
Идёт набор NCT07447505

Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting

Без фазы С лечением Glycemic Response; Satiety Fasting, Time Restricted Dietary Intervention Postprandial Glucose

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: High-Protein, High-Fiber Meal, Low-Protein, Low-Fiber Meal.
Кому может быть актуально
Состояния в реестре: Glycemic Response; Satiety, Fasting, Time Restricted, Dietary Intervention, Postprandial Glucose. Базовые параметры: от 18 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
Саудовская Аравия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effect of a High-Protein, High-Fiber Pre-Fast Meal on Satiety and Glycemic Profiles During Fasting: A Randomized Crossover Study

Обзор

This randomized crossover study investigates the effect of consuming a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours in healthy adults. Participants will complete two dietary conditions in a randomized order: a standardized high-protein, high-fiber pre-fast meal and a low-protein, low-fiber pre-fast meal guided by dietary instructions. Each condition will be followed for two consecutive days and separated by a three-day washout period. Outcomes include subjective appetite sensations during fasting hours, glycemic profiles assessed using continuous glucose monitoring (CGM), and exploratory analyses examining the association between glucose dynamics and appetite sensations.

Подробное описание

This study is a randomized crossover interventional trial conducted in healthy adults to evaluate the effect of a high-protein, high-fiber pre-fast meal on subjective satiety and glycemic responses during fasting hours.

Each participant will complete two study conditions in a randomized sequence: a high-protein, high-fiber pre-fast meal condition and a low-protein, low-fiber pre-fast meal condition. Each condition will be followed for two consecutive days and separated by a three-day washout period to minimize potential carryover effects.

During the high-protein, high-fiber condition, participants will consume a standardized pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g). Meals will be provided in pre-measured portions by the research team.

During the low-protein, low-fiber condition, participants will receive standardized written dietary instructions, including a list of foods to avoid, to guide consumption of a low-protein, low-fiber pre-fast meal. No calorie restriction will be applied in either study condition.

Subjective appetite sensations, including hunger, fullness, desire to eat, and prospective food consumption, will be assessed using visual analogue-type scales at predefined time points across the fasting day. Glycemic profiles will be continuously assessed using continuous glucose monitoring (CGM).

Exploratory analyses will examine temporal associations between CGM-derived glucose levels and glucose trends and subjective appetite sensations across the study day.

Вмешательства

  • Другое High-Protein, High-Fiber Meal
    Participants consume a standardized high-protein, high-fiber pre-fast meal consisting of oats (40 g), Greek yogurt (160 g), peanut butter (16 g), dried cranberries (10 g), and almonds (6 g) for two consecutive days.
  • Другое Low-Protein, Low-Fiber Meal
    Participants follow standardized written dietary instructions, including a list of foods to avoid, to consume a low-protein, low-fiber pre-fast meal for two consecutive days. No calorie restriction is applied.

Первичные конечные точки

  • Daytime Satiety During Fasting Hours [Срок оценки: Assessed at baseline prior to the pre-fast meal, 30 and 60 minutes post-meal, mid-afternoon (approximately 4:00 PM), and 30 minutes prior to breaking the fast during each intervention condition.]
Вторичные конечные точки (2)
  • Glycemic Profiles During Fasting (CGM) [Срок оценки: Assessed on Day 1 and Day 2 of each intervention period during the fasting window from completion of the pre-fast meal until breaking the fast.]
  • Post-Meal CGM Glucose Response [Срок оценки: 0-120 minutes after the pre-fast meal during each intervention condition.]

Критерии участия

Критерии включения

  • Adults aged 18 years and older
  • Willingness to comply with study procedures, including fasting and continuous glucose monitoring
  • Ability to provide informed consent

Критерии исключения

  • Diagnosed diabetes mellitus or known metabolic disease
  • History of cardiovascular, gastrointestinal, or endocrine disorders that may affect study outcomes
  • Use of medications known to affect glucose metabolism or appetite
  • Pregnancy or lactation
  • Known allergy or intolerance to any study meal components (oats, dairy, peanuts, nuts, cranberries)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Саудовская Аравия · 1 центр
  • King Faisal University — Al-Ahsa

Идентификаторы

NCT: NCT07447505 · KFU-2026-ETHICS3958

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗