Fasting Effects on Metabolism and Immunity Study in Human
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: Fasting.
- Кому может быть актуально
- Состояния в реестре: Fasting. Базовые параметры: 18 лет — 65 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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Официальное название
Study on the Effect and Mechanism of Fasting on Human Metabolism and Immunity
Обзор
This study aims to investigate the effects of 1-week fasting but not prohibiting water drink on human immune function, metabolic indicators, and brain function in human, and to explore the underlying mechanisms of these changes from a multi-omics perspective and/or other ways.
Подробное описание
As a historic practice, fasting has a place in religion, culture and modern medicine. In recent years, studies have found that moderate food interruption can positively affect metabolism, immunity, and brain function. It can promote cellular autophagy, improve insulin sensitivity, reduce inflammation, and may protect brain health. Intermittent fasting is thought to improve metabolic health, reduce the risk of obesity and type 2 diabetes, and promote cellular self-repair by regulating signaling pathways. Food fasting also improves insulin sensitivity, reduces blood glucose, reduces inflammatory markers, and improves fat oxidation rate, contributing in the prevention and treatment of metabolic diseases. Moreover, food fasting can regulate immune cell function, reduce chronic inflammation, and may regulate immune function by affecting gut microbiota diversity. In terms of brain function, fasting may improve cognitive function by promoting neuroplasticity and enhancing neuroprotective mechanisms. However, most of the existing studies focus on animal experiments, lack large-scale human clinical trials, and the mechanism of feeding is not completely clear. This study will explore the effects of complete fasting for 1 week (but can feel free to drink water) on human immune function, metabolic indicators and brain function in human, and analyze its change mechanism from a multi-omics perspective and/or other ways, so as to provide new data support for understanding the biological mechanism of fasting, and promote its application in disease prevention and treatment.
Вмешательства
- Другое Fasting
One-week fasting without limit of water drink (Participants can feel free to drink water )
Первичные конечные точки
- The change of cytokine levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of metabolite levels in subjects' blood (and/or urine/stool) samples from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
Вторичные конечные точки (7)
- The change in concentration of intestinal flora species,rate of change in bacterial diversity,abundance of functional genes in subjects' stool samples from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of brain function from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of blood lipid levels from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of homocysteine levels from T1 to T2, T3, T4, and T5 [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of insulin levels in subjects' blood samples from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of thyroid function level from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
- The change of body fat percentage from T1 to T2, T3, T4, and T5. [Срок оценки: T1 (Baseline/Pre-fasting): Day 0; T2 (End of one week fasting): Day 8; T3 (End of one week re-feeding): Day 15; T4 (End of four weeks re-feeding): Day 36; T5 (End of twelve weeks re-feeding): Day 92.]
Критерии участия
Критерии включения
- Age 18-65 years old, gender is not limited;
- BMI≥18.5;
- Can tolerate a certain degree of hunger;
- Can voluntarily sign written informed consent.
Критерии исключения
- Women planning pregnancy, pregnancy and breastfeeding;
- Previous liver disease, chronic kidney disease, heart disease and cerebrovascular disease;
- Suffering from acute infectious diseases or chronic wasting diseases;
- Have used antibiotic drugs in the past 3 months, and have used prebiotic or probiotic supplements or products in the past month;
- Participate in other clinical investigators within 3 months before enrollment in this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Китай · 1 центр
- Xuanwu Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT06779201 · fasting