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Идёт набор NCT06885255

Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome

Без фазы С лечением Metabolic Syndrome Obesity and Obesity-related Medical Conditions

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: Alternate day fasting, Time restricted eating, High-intensity interval training.
Кому может быть актуально
Состояния в реестре: Metabolic Syndrome, Obesity and Obesity-related Medical Conditions. Базовые параметры: 18 лет — 80 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
Германия
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

Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study

Обзор

The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is: Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome? Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.

Вмешательства

  • Другое Alternate day fasting
    Participants are instructed to alternate between consuming 100% of their usual energy intake on one day and only 25% on the following day.
  • Другое Time restricted eating
    Subjects are instructed to limit their energy intake to 8 hours a day and to fast for the remaining 16 hours.
  • Другое High-intensity interval training
    Patients participate in high-intensity interval training.

Первичные конечные точки

  • hsCRP [Срок оценки: From enrollment to the end of intervention at 3 months.]
Вторичные конечные точки (12)
  • inflammatory markers and metabolic markers [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • waist circumference [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • fasting blood glucose [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • triglycerides [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • cholesterol [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • blood pressure [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • cardiometabolic risk profile [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • maximal oxygen uptake [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • liver fat status [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • composition of the intestinal and oral microbiome [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • skin microbiome [Срок оценки: From enrollment to the end of intervention at 3 months.]
  • cortisol [Срок оценки: From enrollment to the end of intervention at 3 months.]

Критерии участия

Критерии включения

  • Written consent to participate in the study.
  • Persons aged 18 years and older.
  • Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.

Критерии исключения

  • Pregnant or nursing individuals.
  • Cardiovascular diseases or orthopedic restrictions that prevent exercise.
  • Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
  • Body weight greater than 200 kg (maximum capacity of training equipment).
  • Individuals with mental illnesses that may impair their ability to understand or participate in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Германия · 1 центр
  • Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen — Erlangen

Идентификаторы

NCT: NCT06885255 · 22-60_2-B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗