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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07345572
Acronym
eTRE
Enrollment
36
Registered
2026-01-15
Start date
2026-02-25
Completion date
2027-07-01
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Management, Time Restricted Eating

Keywords

Asthma, time restricted eating, inflammatory markers, oxidative stress markers, pulmonary function parameters, quality of life, adherence

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.

Interventions

OTHEREarly 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.

OTHERHabitual 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.

Sponsors

De Montfort University
Lead SponsorOTHER
King Saud Bin Abdulaziz University for Health Sciences
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Lung Function Parameters, FEV1 in Liters (L)At baseline and after 1 week in each study armA spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FVC in Liters (L)At baseline and after 1 week in each study armA spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FEV1/ FVC ratioAt baseline and after 1 week in each study armA spirometry test will be conducted to gather information about lung function parameters.

Secondary

MeasureTime frameDescription
Blood for health biomarkersAt baseline and after 1 week in each study armChanges in plasma-based health biomarkers will be assessed from acellular plasma extracted from venous blood samples to explore physiological responses to the intervention. Biomarker results will be summarized descriptively.
Urinary Biomarker ProfileAt baseline and after 1 week in each study armThe urinary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Results will be summarized descriptively.
Salivary Metabolomic ProfileAt baseline and after 1 week in each study armSalivary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Metabolomic features will be summarized descriptively.
Changes in Quality of Life using Asthma Quality of Life Questionnaire (AQLQ)At baseline and after 1 week in each study armThe Asthma Quality of Life Questionnaire (AQLQ) will be given to assess changes in quality of life in individuals with asthma.
Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)At baseline and after 1 week in each study armFractional exhaled nitric oxide (FeNO) test will be conducted to gather information about airway inflammation.
Changes in Quality of Life using PROMIS Global Health v1.2At baseline and after 1 week in each study armThe PROMIS Global Health v1.2 will be given to assess changes in quality of life for individuals without asthma.
Changes in asthma control using Asthma Control Questionnaire (ACQ)At baseline and after 1 week in each study armAsthma Control Questionnaire will be given to individuals with asthma to assess their asthma control.
Semi-structured interview for assessing quality of life and acceptability of interventions.After 1 week of eTREA semi-structured interview will be conducted among participants with mild asthma who are assigned to the eTRE group to assess the challenges they faced and their experiences after the eTRE intervention.

Countries

United Kingdom

Contacts

CONTACTNouf N Alotaibi
P2876983@my365.dmu.ac.uk+447852689959

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026