Asthma ManagementeTRENCT07345572
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
A study testing Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) and Habitual Diet (HD) and Early Time-Restricted Eating (eTRE) in people with Asthma Management and Time Restricted Eating, run by De Montfort University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma Management, Time Restricted Eating
- What is being tested?
- Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) and Habitual Diet (HD) and Early Time-Restricted Eating (eTRE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Health and Life Science
Leicester, England
Nouf Alotaibi, P2876983@my365.dmu.ac.uk
Mariasole Da Boit, Phd
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma Management, Time Restricted Eating
- Being tested
- Early Time-Restricted Eating (eTRE) and Habitual Diet (HD), Habitual Diet (HD) and Early Time-Restricted Eating (eTRE)
- Keywords
- Asthma, time restricted eating, inflammatory markers, oxidative stress markers, pulmonary function parameters, quality of life, adherence
- Medical subject headings
- Intermittent Fasting, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)Other
Also called eTRE
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.
Habitual Diet (HD) and Early Time-Restricted Eating (eTRE)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Habitual Diet (HD) and early Time Restricted Eating (eTRE) | Active comparator | 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. Receives: Other: Habitual Diet (HD) and Early Time-Restricted Eating (eTRE) |
| early Time Restricted Eating (eTRE) and Habitual Diet (HD) | Active comparator | 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. Receives: Other: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Function Parameters, FEV1 in Liters (L)
A spirometry test will be conducted to gather information about lung function parameters.
Measured: At baseline and after 1 week in each study arm
Lung Function Parameters, FVC in Liters (L)
A spirometry test will be conducted to gather information about lung function parameters.
Measured: At baseline and after 1 week in each study arm
Lung Function Parameters, FEV1/ FVC ratio
A spirometry test will be conducted to gather information about lung function parameters.
Measured: At baseline and after 1 week in each study arm
Secondary outcomes (8)
Blood for health biomarkers
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.
Measured: At baseline and after 1 week in each study arm
Urinary Biomarker Profile
The urinary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Results will be summarized descriptively.
Measured: At baseline and after 1 week in each study arm
Salivary Metabolomic Profile
Salivary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Metabolomic features will be summarized descriptively.
Measured: At baseline and after 1 week in each study arm
Changes in Quality of Life using Asthma Quality of Life Questionnaire (AQLQ)
The Asthma Quality of Life Questionnaire (AQLQ) will be given to assess changes in quality of life in individuals with asthma.
Measured: At baseline and after 1 week in each study arm
Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)
Fractional exhaled nitric oxide (FeNO) test will be conducted to gather information about airway inflammation.
Measured: At baseline and after 1 week in each study arm
Changes in Quality of Life using PROMIS Global Health v1.2
The PROMIS Global Health v1.2 will be given to assess changes in quality of life for individuals without asthma.
Measured: At baseline and after 1 week in each study arm
Changes in asthma control using Asthma Control Questionnaire (ACQ)
Asthma Control Questionnaire will be given to individuals with asthma to assess their asthma control.
Measured: At baseline and after 1 week in each study arm
Semi-structured interview for assessing quality of life and acceptability of interventions.
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.
Measured: After 1 week of eTRE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start25 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- De Montfort University
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud Bin Abdulaziz University for Health Sciences
- Responsible party
- Principal investigator, Nouf Alotaibi, De Montfort University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345572
- Sponsor's protocol ID
- LSREF2568554
- Acronym
- eTRE
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to institutional policy related to participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Early Time-Restricted Eating on Health Outcomes and Quality of Life in Adults With and Without Asthma
- ClinicalTrials.gov ID
- NCT07345572
- Acronym / sponsor ID
- eTRE / LSREF2568554
- Conditions
- Asthma Management, Time Restricted Eating
- Keywords
- Asthma, time restricted eating, inflammatory markers, oxidative stress markers, pulmonary function parameters, quality of life, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- De Montfort UniversityUniversity, hospital or other
- Collaborators
- King Saud Bin Abdulaziz University for Health Sciences
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Habitual Diet (HD) and early Time Restricted Eating (eTRE) | Active comparator | 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. |
| early Time Restricted Eating (eTRE) and Habitual Diet (HD) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- Moderate to severe asthma
- Pregnant
- Smoking
- Systemic corticosteroids.
- History of recent respiratory disease, current chest infection, and collapsed lung.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)Also: eTREThe 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) |
| 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) |
Primary outcome
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.
8 secondary outcomes
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
Fractional Exhaled Nitric Oxide (FeNO) in parts per billion (ppb)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to institutional policy related to participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) and Habitual Diet (HD) and Early Time-Restricted Eating (eTRE) in people with Asthma Management and Time Restricted Eating, run by De Montfort University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouf N Alotaibi (+447852689959, P2876983@my365.dmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function Parameters, FEV1 in Liters (L) (time frame: At baseline and after 1 week in each study arm). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.