Impact of Intermittent Fasting on Sleep and Quality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversité Libre de Bruxelles
About this trial
The goal of this clinical trial is to investigate the impact of intermittent fasting on sleep, quality of life and fatigue among healthy volunteers. The main questions aim to answer:
Whether intermittent fasting would allow participants to experience an improvement in their sleep quality, duration and latency? Whether intermittent fasting would ameliorate participants' quality of life and reduce chronic fatigue symptoms? Researchers will compare the two most prevailing fasting windows of intermittent diet including an early morning feeding window (8 a.m.-4 p.m.) and a late feeding window (12 p.m.-8 p.m.) to see if there is a difference among these feeding windows on sleep and quality of life.
Participants will:
* Be divided into two groups (group A and group B) that will alternate their fasting windows. * Group A will start with intermittent fasting over a feeding period from 12 p.m. to 8 p.m. for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 8 a.m. to 4 p.m. * Group B will follow intermittent fasting over a feeding period from 8 a.m. to 4 p.m for one month, then a two weeks period of usual eating habits (washout period) and finally one month of intermittent fasting with a feeding period from 12 p.m. to 8 p.m. * At enrollment, at the end of each month of intermittent fasting and at the end of washout period participants will be asked to complete some questionnaires and will be submitted to anthropometric measurements using impedance scales. * Participants will be asked to complete an electronic 24 hour recall diary using the Automated Self-Administered 24h Dietary Assessment (ASA24) Tool software once per week every week during study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects
Adult subjects - age: between 18 and 65 years old
Subjects with a BMI between 18.5 and 29.9 kg/m²
Male and female subjects
Disqualifiers
Subjects < 18 years old
Subjects with Diabetes Mellitus (type 1 and type 2)
Pregnant and/or breastfeeding and/or postpartum women
Underweight subjects (BMI < 18.5)
Trial design
Design model
Crossover
Treatments tested in this trial
Intermittent Fasting - Late feeding window
Other interventionIntermittent fasting is an eating pattern that consists of alternating periods of fasting of varying duration with periods of eating. In the present study, all participants will follow a time-restricted feeding/eating (TRF/E) that restricts all dietary intake to an 8- hour daily eating window. There will be two different feeding periods. The first window will allow a feeding period from12 p.m. to 8 p.m. (late feeding window).
Intermittent Fasting - Early feeding window
Other interventionIntermittent fasting is an eating pattern that consists of alternating periods of fasting of varying duration with periods of eating. In the present study, all participants will follow a time-restricted feeding/eating (TRF/E) that restricts all dietary intake to an 8- hour daily eating window. There will be two different feeding periods. The second window will allow a feeding period from 8 a.m. to 4 p.m (early feeding window).
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Intermittent Fasting - Group AActive comparator 2 interventions
Group B: Intermittent Fasting - Group BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Impact of intermittent fasting on sleep
The primary outcome of this study will be to investigate the impact of intermittent fasting on sleep including sleep quality, efficiency, duration, and sleep latency among healthy individuals. This will be carried out using the Pittsburgh Sleep Quality Index (PSQI) : a standardized self-report questionnaire assessing the subjective sleep quality, sleep efficiency (percentage of time spent in bed actually asleep), sleep duration, and sleep latency (time taken to fall asleep) over the last month. It consists of 19 items, resulting in a total score of 0 to 21. Scores above 5 can be used as an indicator of poor sleep quality.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)2
Impact of intermittent fasting on quality of life
The second objective will be to explore the impact of intermittent fasting on participants' quality of life using the validated questionnaire Short Form Health 36 (SF-36) that objectively measures quality of life by covering eight domains of health. Sf-36 assesses eight scales: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, energy/fatigue, social functioning, general mental health (emotional well-being), and role limitations due to emotional health, measured by 36 questions. All scores are recoded with a maximum score of 100. A higher score indicates a better quality of life.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)3
Impact of intermittent fasting on fatigue
Another primary outcome that will be explored is the impact of intermittent fasting on symptoms of fatigue. This will be carried out using the Fatigue Assessment Scale (FAS), a 10-item scale assessing symptoms of chronic fatigue. Each item of the FAS is answered using a 5-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Total scores range from 10 to 50 with higher scores indicating higher levels of fatigue.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)Secondary outcomes
1
Impact of intermittent fasting on physical activity
The impact of intermittent fasting on physical activity will be eamined using the Global Physical Activity Questionnaire (GPAQ). It collects information on physical activity participation in three domains including activity at work, travel to and from places and recreational activities as well as sedentary behaviour, comprising 16 questions.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)2
Effect of intermittent fasting on Body Mass Index
Anthropometric measurements including weight in kilograms and height in centimeters will be carried out and combined in order to report Body Mass Index (BMI) in kg/m\^2.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)3
Impact of Intermittent fasting on total energy intake
Data concerning total energy intake (kilocalories/day) will be analyzed. Subjects will be asked to use the ASA24 (Automated Self-Administered 24h Dietary Assessment Tool) software once per week, which is a 24-hour food diary. Its purpose is to collect detailed and accurate information on all foods, beverages, and supplements (vitamins, minerals, medicinal plants, etc.) consumed by the subject during the last 24 hours.
Time frame
All participants will complete the ASA24 24-hour recall diary once per week for the total 10-week duration of the study (10 times in total). The participants will choose the day during the week that they want to recall their diet.4
Effect of intermittent fasting on Muscle Mass
Anthropometric measurements including muscle mass estimation in kilograms will be carried out in order to observe any possible changes on body composition.
Time frame
In total 4 times: at baseline assessment (day 1), at the end of the first month of intermittent fasting (day 28), at the end of the washout period (day 42), at the end of second month of intermittent fasting (day 70)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov