An interventional study of Early Time-Restricted Eating (eTRE) and Habitual Diet (HD) and Habitual Diet (HD) and Early Time-Restricted Eating (eTRE) in Asthma Management and Time Restricted Eating, sponsored by De Montfort University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by De Montfort University · Not applicable, Interventional, and Other
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.
During the study, participants will be asked to:
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
Also known as: 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.
Lung Function Parameters, FEV1 in Liters (L)
A spirometry test will be conducted to gather information about lung function parameters.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and after 1 week in each study arm
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 1 week of eTRE
A Food Diary Record
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.
Time frame: During the 7-day intervention period (any 3 days)
Adherence Monitoring
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.
Time frame: Before eTRE
Demographic Data
Demographic data such as age, sex and ethnicity.
Time frame: At baseline
Body weight in kilograms (Kg)
Calibrated electronic scales will be used to measure body weight in kilograms.
Time frame: At baseline and after 1 week in each study arm
Height in centimeters (cm)
A stadiometer will be used to measure height in centimeters.
Time frame: At baseline and after 1 week in each study arm
Changes in physical activity levels using International Physical Activity Questionnaire (IPAQ)
IPAQ questionnaire will be given to individuals with and without asthma to assess their physical activity levels.
Time frame: At baseline
Chronotype assessment using the Morningness-Eveningness Questionnaire (MEQ)
Morningness-Eveningness Questionnaire will be given to individuals with and without asthma to identify their chronotypes.
Time frame: At baseline
Body Mass Index (BMI)
BMI will be calculated using the formula BMI = body weight \[kg\]/ (height \[m\])2.
Time frame: At baseline and after 1 week in each study arm
Plan to share: No — IPD will not be shared due to institutional policy related to participant confidentiality.
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