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)

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 (the control group). Participants can continue to eat their normal food; only the timing of meals will change.

Study Overview

• Status: Not yet recruiting
• Conditions: Time Restricted Eating; Asthma Management
• Intervention / Treatment: Other: Habitual Diet (HD) and Early Time-Restricted Eating (eTRE); Other: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)

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 and physical activity.
• 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 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: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nouf N Alotaibi; Phone Number: +447852689959; Email: P2876983@my365.dmu.ac.uk

Study Locations

• United Kingdom
  • England
    • Leicester, England, United Kingdom
      • Health and Life Science
      • Contact: Nouf Alotaibi; Email: P2876983@my365.dmu.ac.uk
      • Principal Investigator: Mariasole Da Boit, Phd
      • Sub-Investigator: Eleni Karasouli, Phd
      • Sub-Investigator: Martin Grootveld

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults between 18 and 65 years old.
• Control 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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 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 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 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

Outcome Measure	Measure Description	Time Frame
Lung Function Parameters, FEV1 in Liters (L)	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)	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	A spirometry test will be conducted to gather information about lung function parameters.	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.	At baseline and after 1 week in each study arm

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	After 1 week of eTRE
Urinary Biomarker Profile	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	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)	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

Outcome Measure	Measure Description	Time Frame
Demographic Data	Demographic data such as age, sex and ethnicity.	At baseline
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.	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.	Before eTRE
Body weight in kilograms (Kg)	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)	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)	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)	Morningness-Eveningness Questionnaire will be given to individuals with and without asthma to identify their chronotypes.	At baseline

Collaborators and Investigators

• Sponsor: De Montfort University
• Collaborators: King Saud Bin Abdulaziz University for Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; quality of life; adherence; time restricted eating; inflammatory markers; oxidative stress markers; pulmonary function parameters
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Behavior; Feeding Behavior; Fasting; Asthma; Intermittent Fasting
• Other Study ID 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