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.
This is a randomized clinical trial focusing on the effect of intermittent fasting on sleep and quality of life among healthy population. More specifically, the first objective 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. The second objective will be to explore the impact of intermittent fasting on participants' quality of life and fatigue using validated questionnaires. The third objective is to compare the effect of the two prevailing fasting windows including early morning feeding window (8 a.m.-4 p.m.) and late feeding window (12 p.m.-8 p.m.) on sleep and quality of life. The investigators expect that intermittent fasting would have a positive effect on sleep and would allow participants to experience an improvement in their sleep during this practice. The investigators also assume that intermittent fasting would have a positive effect on participants' quality of life and fatigue. Moreover, intermittent fasting during the early morning feeding window (8 a.m.-4 p.m.) would have a more positive impact on sleep and quality of life compared to the late feeding window (12 p.m.-8 p.m.) because it would be more aligned with the circadian rhythm. This project will be conducted over a 10-week period. Subjects will be divided into two groups (group A and group B) that will alternate their fasting windows each month. Each group will consist of 36 male and female volunteers, adults, aged between 18 and 65 years old, and with a BMI between 18.5 and 29.9. At recruitment, all subjects will provide their written informed consent prior to enrolling in the study. Once the subject's consent is obtained, the participants will be randomly assigned to Group A or Group B. More specifically, during baseline assessment, the participants will randomly draw an envelope containing a piece of paper labeled Group A or Group B. There will be as many envelopes as there are participants, half containing the Group A paper and the other half containing the Group B paper. Once the subject will be assigned to their group, they will be labeled with a number (ranging from 1 to 36) which will allow us to maintain their anonymity. The study will last 10 weeks in total, with 4 weeks for each window, followed by a 2-week "washout" period where the subjects follow their usual diet between each group of 4 weeks intermittent fasting period. For the first month, group A will follow a feeding period from 12 p.m. to 8 p.m. (known as late feeding window) and group B will follow a feeding period from 8 a.m. to 4 p.m. (known as early feeding window). The following 2 weeks both groups will return to their usual eating habits. For the second month, group A will follow an early feeding window while group B will follow a late feeding window. At enrollment, information concerning baseline characteristics such as age, body mass index (BMI), profession, physical activity, usual eating habits and smoking status, will be collected. During baseline assessment, at the end of each month and at the end of the washout period all participants will complete four validated questionnaires to assess any changes they may have experienced in sleep, quality of life, fatigue, and physical activity. Moreover, during these appointments, anthropometric measurements including height (cm), BMI (kg/m2), muscle mass (kg), visceral mass (kg), fat mass (kg), bone mineral mass (kg), waistline (cm) and waist-hip ratio will be carried out using impedance scales in order to observe any possible changes on body composition. Lastly, participants will be asked verbally to mention if they have experienced any side effects such as headache, vertigo, nausea, vomiting, abdominal pain, changes in bowel movements, fatigue, mood swing. Subjects will also be required to use the Automated Self-Administered 24h Dietary Assessment (ASA24) 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, etc.) consumed by the subject during the last 24 hours. Data concerning total energy intake (kcal/day), protein intake (gr/day), carbohydrates intake (gr/day), fat intake (gr/day), fibers intake (gr/day), amount of water (L/day) and alcohol intake (gr/day) will be analyzed. 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 PSQI - Pittsburgh Sleep Quality Index: 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. 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, with an additional question on health change/transition. All scores will be recoded with a maximum score of 100. A higher score indicates a better quality of life. 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. In addition, the impact of intermittent fasting on physical activity will be examined using the Global Physical Activity Questionnaire (GPAQ). Information concerning participation in physical activity in three areas (work activity, travel to and from places, recreational activities) as well as sedentary behavior will be collecting through 16 questions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
36
Intermittent 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 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).
Libre University, Faculty of Human Motor Sciences, Campus Erasme
Brussels, Belgium
RECRUITINGImpact 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)
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)
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)
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)
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)
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.
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)
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Effect of intermittent fasting on Visceral Mass
Anthropometric measurements including visceral 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)
Effect of intermittent fasting on Fat Mass
Anthropometric measurements including fat 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)
Effect of intermittent fasting on Bone Mineral Mass
Anthropometric measurements including bone mineral 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)
Effect of intermittent fasting on Waistline
Anthropometric measurements including waistline in centimeters 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)
Effect of intermittent fasting on Waist-hip Ratio
Anthropometric measurements including the calculation of waist-hip ratio 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)
Impact of Intermittent fasting on Macronutrient intake
Data concerning macronutrient intake including protein intake (grams/day), carbohydrates intake (grams/day), fat intake (grams/day) and fibers intake (grams/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.
Impact of Intermittent fasting on water intake
Data concerning total amount of water (Liters/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.
Impact of Intermittent fasting on alcohol intake
Data concerning alcohol intake (grams/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.