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NCT Number: NCT07345572

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

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.

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Key information

Conditions

Asthma Management Asthma Behavior Bronchial Diseases Fasting Feeding Behavior Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Intermittent Fasting Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Time Restricted Eating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Life Science

Leicester, England, United Kingdom

Location contact

Eleni Karasouli, Phd

SUB_INVESTIGATOR

Mariasole Da Boit, Phd

PRINCIPAL_INVESTIGATOR

Martin Grootveld

SUB_INVESTIGATOR

Nouf Alotaibi

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)

Other

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

Habitual Diet (HD) and Early Time-Restricted Eating (eTRE)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Demographic Data

    Time frame: At baseline

    Demographic data such as age, sex and ethnicity.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nouf N Alotaibi

CONTACT

[email protected]

+447852689959

Sponsors and collaborators

Lead sponsor

De Montfort University

Other

Collaborators

  • King Saud Bin Abdulaziz University for Health Sciences

Registry information

Official study title

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

Acronym: eTRE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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