Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With and Without Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- De Montfort University
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Lung Function Parameters, FEV1 in Liters (L)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) (Other)
Outcomes
Primary Outcomes
Lung Function Parameters, FEV1 in Liters (L)
Time Frame: 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)
Time Frame: 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
Time Frame: At baseline and after 1 week in each study arm
A spirometry test will be conducted to gather information about lung function parameters.
Secondary Outcomes
- 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)
Investigators
Nouf Alotaibi
Principal Investigator
De Montfort University