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)

De Montfort University

Status: Not yet enrolling

Conditions: Asthma Management; Time Restricted Eating

Treatments: Other: Habitual Diet (HD) and Early Time-Restricted Eating (eTRE); Other: Early Time-Restricted Eating (eTRE) and Habitual Diet (HD)

Study type: Interventional

Funder types: Other

Identifiers

NCT07345572

LSREF2568554

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

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

Active Comparator group

Description:

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.

Treatment:

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

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

Active Comparator group

Description:

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.

Treatment:

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