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Not yet recruiting 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

No phase Interventional Asthma Management Time Restricted Eating

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD), Habitual Diet (HD) and Early Time-Restricted Eating (eTRE).
Who it may be relevant to
Registry conditions: Asthma Management, Time Restricted Eating. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 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.

Interventions

  • 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 two weeks washout period, participants will be asked to follow their habitual diet for one week.
  • Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 1 center
  • Health and Life Science — Leicester

Identifiers

NCT: NCT07345572 · LSREF2568554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗