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Набор скоро начнётся NCT07345572

Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With Mild Controlled Asthma Compared to Healthy Adults

Без фазы С лечением Asthma Management Time Restricted Eating

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 (eTRE) and Habitual Diet (HD), Habitual Diet (HD) and Early Time-Restricted Eating (eTRE).
Кому может быть актуально
Состояния в реестре: Asthma Management, Time Restricted Eating. 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
Великобритания
Следующий шаг
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Официальное название

Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With and Without Asthma

Обзор

This study aims to explore how early time-restricted eating (eTRE) - where all daily meals are eaten within a specific time window - affects health and quality of life in adults. The researchers will compare results between adults with mild, well-controlled asthma and adults without asthma (the control group). Participants can continue to eat their normal food; only the timing of meals will change.

Подробное описание

During the study, participants will be asked to:

* Follow an early time-restricted eating schedule for one week and their usual eating schedule for another week while keeping to their usual diet and physical activity. * Attend four visits to the research facility on campus. * Provide saliva, blood, and urine samples for health marker analysis. * Complete breathing tests (spirometry and FeNO) to measure lung function. * Complete short questionnaires about physical activity and quality of life. * Take part in a short interview about their asthma symptoms and quality of life. * Keep a brief food diary each week. * Provide details of any medications they currently take.

Вмешательства

  • Другое Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)
    The participants who are assigned to eTRE will be asked to eat from 8 am to 4 pm without restriction on the quantity or amount of food and fast for the rest of the time except for drinking water for one week. After two weeks washout period, participants will be asked to follow their habitual diet for one week.
  • Другое Habitual Diet (HD) and Early Time-Restricted Eating (eTRE)
    The participants will be asked to follow their habitual diet for one week. After two weeks washout period, the participants will be assigned to eTRE and asked to eat from 8 am to 4 pm without restriction on the quantity or amount of food and fast for the rest of the time except for drinking water for one week.

Первичные конечные точки

  • Lung Function Parameters, FEV1 in Liters (L) [Срок оценки: At baseline and after 1 week in each study arm]
  • Lung Function Parameters, FVC in Liters (L) [Срок оценки: At baseline and after 1 week in each study arm]
  • Lung Function Parameters, FEV1/ FVC ratio [Срок оценки: At baseline and after 1 week in each study arm]
  • Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb) [Срок оценки: At baseline and after 1 week in each study arm]
Вторичные конечные точки (7)
  • Blood for health biomarkers [Срок оценки: At baseline and after 1 week in each study arm]
  • Urinary Biomarker Profile [Срок оценки: At baseline and after 1 week in each study arm]
  • Salivary Metabolomic Profile [Срок оценки: At baseline and after 1 week in each study arm]
  • Changes in Quality of Life using Asthma Quality of Life Questionnaire (AQLQ) [Срок оценки: At baseline and after 1 week in each study arm]
  • Changes in Quality of Life using PROMIS Global Health v1.2 [Срок оценки: At baseline and after 1 week in each study arm]
  • Changes in asthma control using Asthma Control Questionnaire (ACQ) [Срок оценки: At baseline and after 1 week in each study arm]
  • Semi-structured interview for assessing quality of life and acceptability of interventions. [Срок оценки: After 1 week of eTRE]

Критерии участия

Критерии включения

  • Adults between 18 and 65 years old.
  • Control group: individuals without asthma
  • Asthma group: Have already been diagnosed with controlled mild asthma.
  • Not following any diet regimen.
  • Able to read the information pack and give consent in English.

Критерии исключения

  • Moderate to severe asthma
  • Pregnant
  • Smoking
  • Systemic corticosteroids.
  • History of recent respiratory disease, current chest infection, and collapsed lung.
  • History of recent surgery (last 2 months), including thoracic, abdominal, and eye surgery.
  • Being diagnosed with cardiovascular diseases, e.g., unstable angina, a heart attack, uncontrolled high blood pressure, stroke, and aneurysm.
  • Broken ribs or neck vertebrae.
  • Cancer.
  • History of autoimmune diseases
  • Being diagnosed with an eating disorder.
  • Overnight shift work

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Великобритания · 1 центр
  • Health and Life Science — Leicester

Идентификаторы

NCT: NCT07345572 · LSREF2568554

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗