Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With and Without Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Lung Function Parameters, FEV1 in Liters (L)
研究概览
简要总结
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 (non-asthma group). Participants can continue to eat their normal food; only the timing of meals will change.
详细描述
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.
- 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, chronotype, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 65 years old.
- •Non asthma 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.
排除标准
- •Moderate to severe asthma
- •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.
- •History of autoimmune diseases
- •Being diagnosed with an eating disorder.
- •Overnight shift work
研究组 & 干预措施
Habitual Diet (HD) and early Time Restricted Eating (eTRE)
The participants will be asked to follow their habitual diet for one week. After a minimum of 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.
干预措施: Habitual Diet (HD) and Early Time-Restricted Eating (eTRE) (Other)
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 a minimum of two weeks washout period, participants will be asked to follow their habitual diet for one week.
干预措施: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) (Other)
结局指标
主要结局
Lung Function Parameters, FEV1 in Liters (L)
时间窗: At baseline and after 1 week in each study arm
A spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FVC in Liters (L)
时间窗: At baseline and after 1 week in each study arm
A spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FEV1/ FVC ratio
时间窗: At baseline and after 1 week in each study arm
A spirometry test will be conducted to gather information about lung function parameters.
Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)
时间窗: At baseline and after 1 week in each study arm
Fractional exhaled nitric oxide (FeNO) test will be conducted to gather information about airway inflammation.
次要结局
- Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)(At baseline and after 1 week in each study arm)
- Changes in Quality of Life using Asthma Quality of Life Questionnaire (AQLQ)(At baseline and after 1 week in each study arm)
- Changes in Quality of Life using PROMIS Global Health v1.2(At baseline and after 1 week in each study arm)
- Semi-structured interview for assessing quality of life and acceptability of interventions.(After 1 week of eTRE)
- Blood for health biomarkers(At baseline and after 1 week in each study arm)
- Urinary Biomarker Profile(At baseline and after 1 week in each study arm)
- Salivary Metabolomic Profile(At baseline and after 1 week in each study arm)
- Changes in asthma control using Asthma Control Questionnaire (ACQ)(At baseline and after 1 week in each study arm)
研究者
Nouf Alotaibi
Principal Investigator
De Montfort University