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| Name | Class |
|---|---|
| King Saud Bin Abdulaziz University for Health Sciences | OTHER |
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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.
During the study, participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Urinary Biomarker Profile |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nouf N Alotaibi | Contact | +447852689959 | P2876983@my365.dmu.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health and Life Science | Leicester | England | United Kingdom |
IPD will not be shared due to institutional policy related to participant confidentiality.
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| 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. |
|
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 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 |
| 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 |
| 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 |
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 |
| Demographic Data | Demographic data such as age, sex and ethnicity. | At baseline |
| 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 |
| ID | Term |
|---|---|
| D000093763 | Intermittent Fasting |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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