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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDe Montfort University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

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

    Other intervention

    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 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 intervention

    The 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

36 Participants
are divided into 2 treatment groups
Group A: Habitual Diet (HD) and early Time Restricted Eating (eTRE)Active comparator 1 intervention
Group B: early Time Restricted Eating (eTRE) and Habitual Diet (HD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lung Function Parameters, FEV1 in Liters (L)

A spirometry test will be conducted to gather information about lung function parameters.

Time frame
At baseline and after 1 week in each study arm
2

Lung Function Parameters, FVC in Liters (L)

A spirometry test will be conducted to gather information about lung function parameters.

Time frame
At baseline and after 1 week in each study arm
3

Lung Function Parameters, FEV1/ FVC ratio

A spirometry test will be conducted to gather information about lung function parameters.

Time frame
At baseline and after 1 week in each study arm

Secondary outcomes

1

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.

Time frame
At baseline and after 1 week in each study arm
2

Urinary Biomarker Profile

The urinary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Results will be summarized descriptively.

Time frame
At baseline and after 1 week in each study arm
3

Salivary Metabolomic Profile

Salivary metabolomics profile will be assessed to explore changes in metabolites associated with the intervention. Metabolomic features will be summarized descriptively.

Time frame
At baseline and after 1 week in each study arm
4

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.

Time frame
At baseline and after 1 week in each study arm

Other outcomes

1

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.

Time frame
During the 7-day intervention period (any 3 days)
2

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.

Time frame
Before eTRE
3

Demographic Data

Demographic data such as age, sex and ethnicity.

Time frame
At baseline
4

Body weight in kilograms (Kg)

Calibrated electronic scales will be used to measure body weight in kilograms.

Time frame
At baseline and after 1 week in each study arm

Sponsors and contacts

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De Montfort University

Lead sponsor

King Saud Bin Abdulaziz University for Health Sciences

Collaborator