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 (eTRE)

August 11, 2026 updated by: Nouf Alotaibi, De Montfort University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • England
      • Leicester, England, United Kingdom
        • Recruiting
        • Health and Life Science
        • Contact:
        • Principal Investigator:
          • Mariasole Da Boit, Phd
        • Sub-Investigator:
          • Eleni Karasouli, Phd
        • Sub-Investigator:
          • Martin Grootveld

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.
Other Names:
  • eTRE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
A spirometry test will be conducted to gather information about lung function parameters.
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
A spirometry test will be conducted to gather information about lung function parameters.
At baseline and after 1 week in each study arm

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)
Time Frame: 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.
At baseline and after 1 week in each study arm
Blood for health biomarkers
Time Frame: At baseline and after 1 week in each study arm
Changes 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.
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
The Asthma Quality of Life Questionnaire (AQLQ) will be given to assess changes in quality of life in individuals with asthma.
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
The PROMIS Global Health v1.2 will be given to assess changes in quality of life for individuals without asthma.
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
A 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.
After 1 week of eTRE
Urinary Biomarker Profile
Time Frame: At baseline and after 1 week in each study arm
The urinary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Results will be summarized descriptively.
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
Salivary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Metabolomic features will be summarized descriptively.
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
Asthma Control Questionnaire will be given to individuals with asthma to assess their asthma control.
At baseline and after 1 week in each study arm

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic Data
Time Frame: At baseline
Demographic data such as age, sex and ethnicity.
At baseline
A Food Diary Record
Time Frame: During the 7-day intervention period (any 3 days)
A food diary will be given to record and keep track of participants' diet over three consecutive or non-consecutive days, selected by the participants during the 7 days intervention period.
During the 7-day intervention period (any 3 days)
Adherence Monitoring
Time Frame: Before eTRE
All participants will be given an adherence log to fill out daily as we aim to monitor their adherence. The participant will be reminded every day by email to fill out the log and ensure their adherence to the intervention.
Before eTRE
Body weight in kilograms (Kg)
Time Frame: At baseline and after 1 week in each study arm
Calibrated electronic scales will be used to measure body weight in kilograms.
At baseline and after 1 week in each study arm
Height in centimeters (cm)
Time Frame: At baseline and after 1 week in each study arm
A stadiometer will be used to measure height in centimeters.
At baseline and after 1 week in each study arm
Changes in physical activity levels using International Physical Activity Questionnaire (IPAQ)
Time Frame: At baseline
IPAQ questionnaire will be given to individuals with and without asthma to assess their physical activity levels.
At baseline
Chronotype assessment using the Morningness-Eveningness Questionnaire (MEQ)
Time Frame: At baseline
Morningness-Eveningness Questionnaire will be given to individuals with and without asthma to identify their chronotypes.
At baseline
Body Mass Index (BMI)
Time Frame: At baseline and after 1 week in each study arm
BMI will be calculated using the formula BMI = body weight [kg]/ (height [m])2.
At baseline and after 1 week in each study arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
De Montfort University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King Saud Bin Abdulaziz University for Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LSREF2568554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to institutional policy related to participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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