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Идёт набор NCT06546033

Intermittent Fasting and Mediterranean Diet in Patient With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis Intermittent Fasting

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: application of different types of diet.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Intermittent Fasting. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Determination of the Effects of Intermittent Fasting and Mediterranean Diet on Quality of Life, Circadian Rhythm and Appetite Markers in Patient With Multiple Sclerosis

Обзор

When the literature was reviewed, there is no study in which the effects of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients were evaluated and the two diet types were comparatively examined in terms of all these parameters.

Подробное описание

Multiple Sclerosis (MS) is the most common chronic inflammatory disease affecting young adults between the ages of 20-40 years, which causes irreversible neurological damage and symptoms and is influenced by genetic and environmental factors on the Central Nervous System. Depression that may occur in MS patients leads to decreased motivation and negatively affects the quality of life. At the same time, depression may be accompanied by sleep disorders, anxiety, fatigue and eating disorders. Nutrition is recognised as one of the possible risk factors for the development of MS and has potential applications in the management and treatment of the disease. When the literature was reviewed, there is no study evaluating the effect of intermittent fasting and Mediterranean diet on quality of life, sleep, circadian rhythm and appetite hormones leptin and ghrelin levels in MS patients and comparing the two diet types in terms of all these parameters.

Вмешательства

  • Другое application of different types of diet
    application of different types of diet

Первичные конечные точки

  • Biochemical parameter [Срок оценки: baseline- 3 months]
Вторичные конечные точки (3)
  • The Morning and Evening Questionnaire [Срок оценки: baseline- 3 months]
  • Pittsburgh Sleep Quality Index [Срок оценки: baseline- 3 months]
  • Multiple Sclerosis Quality of Life-MuSiQoL [Срок оценки: baseline- 3 months]

Критерии участия

Критерии включения

  • To apply to the neurology outpatient clinic, to be a female between the ages of 18-65 who has been diagnosed with MS by a physician
  • Not being in the attack period
  • Not being in menopause Not being diagnosed with any autoimmune system disease other than -MS that may adversely affect the study,
  • Not following the Mediterranean diet and intermittent fasting programmes in the last three months,
  • Not being diagnosed with an eating behaviour disorder,
  • Not having any communication problems,
  • Signing the informed consent form,
  • Brain MRI within the last three months,
  • Not to be pregnant and lactating
  • No physical disability No history of cancer
  • Body Mass Index between 18,5 kg/m2- 29,9 kg/m2,
  • Not losing 5% and/or more body weight in the last month

Критерии исключения

  • Having a diagnosis of autoimmune system disease that may adversely affect working outside of -MS,
  • To be in the attack period-Being under 18 years of age and over 65 years of age
  • Being in menopause-Mediterranean diet and intermittent fasting feeding programmes within the last three months,
  • Diet therapy that has an effect on the autoimmune system within the last three months,
  • Being diagnosed with eating behaviour disorder,
  • Having any communication problems,- Not signing the informed consent form,
  • Failure to adapt to the work during the working period, to be in a situation/behaviour that may adversely affect the work,
  • To have applied any nutritional intervention during the last three months prior to the study,
  • Taking supplements such as selenium, zinc, iron, vitamin D and/or B12, which may affect the course of the study,
  • To have received cancer treatment and / or to be receiving cancer treatment,
  • Other neurological diseases (e.g. Parkinson's, epilepsy, Alzheimer's),
  • Diagnosed with a disease lasting more than 4 months in the last 12 months and other specialised dietary / compositionally different dietary patterns (e.g. high protein, ketogenic, low energy content < 1000 kcal/day),
  • Body Mass Index <18.5 kg/m2 or >30 kg/m2
  • Losing 5% and/or more body weight in the last month,
  • Having a physical disability

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Nigde Omer Halisdemir University — Niğde

Идентификаторы

NCT: NCT06546033 · 2024-7/286

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗