About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Moderate to severe asthma
Pregnant
Smoking
Systemic corticosteroids.
Trial design
Crossover
Treatments tested in this trial
Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)
Other interventionThe 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 interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Lung Function Parameters, FEV1 in Liters (L)
A spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FVC in Liters (L)
A spirometry test will be conducted to gather information about lung function parameters.
Lung Function Parameters, FEV1/ FVC ratio
A spirometry test will be conducted to gather information about lung function parameters.
Secondary outcomes
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.
Urinary Biomarker Profile
The urinary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Results will be summarized descriptively.
Salivary Metabolomic Profile
Salivary 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)
The Asthma Quality of Life Questionnaire (AQLQ) will be given to assess changes in quality of life in individuals with asthma.
Other outcomes
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.
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.
Demographic Data
Demographic data such as age, sex and ethnicity.
Body weight in kilograms (Kg)
Calibrated electronic scales will be used to measure body weight in kilograms.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
De Montfort University
Lead sponsor
King Saud Bin Abdulaziz University for Health Sciences
Collaborator