Effect of Timed-Restricted Eating on Metabolic Health
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: Early time restricted eating, Late time restricted eating.
- Кому может быть актуально
- Состояния в реестре: Obesity, Non-Alcoholic Fatty Liver Disease, Insulin Resistance. Базовые параметры: 50 лет — 75 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
- Нидерланды
- 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
The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
Обзор
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
Подробное описание
Obesity is an alarming global health issue, with increasing prevalence. Obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (IHTG), multiorgan insulin resistance and type 2 diabetes mellitus. In addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, IHTG and type 2 diabetes mellitus. Time restricted eating (TRE) is a form of intermittent fasting, in which the daily eating period is restricted. The beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.
Вмешательства
- Поведенческое Early time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the early-TRE group is between 7 AM - 5 PM - Поведенческое Late time restricted eating
Subjects will follow an isocaloric diet, designed by a dietician. The eating window for the late-TRE group is between 10 AM - 8 PM
Первичные конечные точки
- Insulin Sensitivity [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
Вторичные конечные точки (12)
- Change in plasma insulin [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in plasma glucose [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in intrahepatic fat [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in beta cell function (C-peptide) [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in insulin aignaling [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Change in glucose variability [Срок оценки: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2]
- De novo lipogenesis [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Immunological markers [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Physical activity [Срок оценки: Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2]
- Functional brain activity [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Psychological factor - Food Craving [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
- Psychological factor - Eating behaviour [Срок оценки: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2]
Критерии участия
Критерии включения
- Ability to provide informed consent;
- BMI > 30kg/m\^2;
- Insulin resistance, as defined by fasting plasma insulin > 62 pmol/L and/or prediabetes, as defined by fasting plasma glucose > 5.3 and < 7.0 mmol/L;
- Stable weight for 3 months prior to study inclusion
- For women, 1 year after last menstrual cycle
Критерии исключения
- Use of any medication, except for those related to treatment of metabolic syndrome;
- Any medical condition interfering with study outcomes or design;
- History of any psychiatric disorder, including eating disorders;
- Performing shift work
- Performing intensive sports (>3 hours/week);
- Smoking;
- Drugs abuse or alcohol abuse (>3 units/day);
- Contraindication for MRI;
- Known lactose/gluten intolerance;
- Known soy, egg, milk or peanut allergy;
- Childhood onset of obesity
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
- Лечение
Центры проведения
Нидерланды · 1 центр
- Amsterdam UMC, location AMC — Amsterdam
Идентификаторы
NCT: NCT06061042 · NL79197.018.21