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

NCT07345572 | Not Yet Recruiting

• 1 other identifier: LSREF2568554
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Time Restricted Eating; Asthma Management

Keywords

Asthma; time restricted eating; inflammatory markers; oxidative stress markers; pulmonary function parameters; quality of life; adherence

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Blood for health biomarkers

  At baseline and after 1 week in each study arm

• Urinary Biomarker Profile

  At baseline and after 1 week in each study arm

• Salivary Metabolomic Profile

  At baseline and after 1 week in each study arm

• Changes in Quality of Life using Asthma Quality of Life Questionnaire (AQLQ)

  At baseline and after 1 week in each study arm

• Changes in Quality of Life using PROMIS Global Health v1.2

  At baseline and after 1 week in each study arm

Other Outcomes (7)

• A Food Diary Record

  During the 7-day intervention period (any 3 days)

• Adherence Monitoring

  Before eTRE

• Demographic Data

  At baseline

Study Arms (2)

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 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)

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 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)

Interventions

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.

Habitual Diet (HD) and early Time Restricted Eating (eTRE)

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.

Also known as: eTRE

early Time Restricted Eating (eTRE) and Habitual Diet (HD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• De Montfort University: lead
• King Saud Bin Abdulaziz University for Health Sciences: collaborator

Study Sites (1)

Health and Life Science

Leicester, England, United Kingdom

Location

MeSH Terms

Conditions

Intermittent Fasting; Asthma

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Nouf N Alotaibi

CONTACT

+447852689959; P2876983@my365.dmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 15, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)