Fasting, IntermittentNCT06865014
Cognitive and Psychomotor Skills and Behavioural Changes During Ramadan in Women
An observational study of Fasting, Intermittent and Food Habits, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This study will observe the participants fasting during the month ramadan. Descriptive characteristics and assessments of sleep, food consumption, body composition, cognitive skills, anticipation time, and physical activity will be conducted before, during and after ramadan. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Fasting, Intermittent, Food Habits, Sleep
- What is being tested?
- Intermittent Ramadan Fasting
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2025to 10 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Adult
Study population: Twenty two healthy, moderately active young women who regularly fast during the month Ramadan will be the participants in this study.
Who may be able to join
- Voluntariness: Participants must be willing to participate in the study voluntarily and provide informed consent.
- Absence of any health issues
- No chronic sleep problems
- No use of sleep medication
- Fasting throughout the study period during the month Ramadan
Who cannot join
- Complications During the Intervention: Participants who experience any complications during the month Ramadan while fasting.
- Irregular fasting behavior during Ramadan
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University, Faculty of Sport Sciences,
Bolu, 14030
About this study
Official title: Changes in Sleep Patterns, Dietary Intake, Cognitive Skills, Anticipation Time and Physical Activity Levels During Ramadan in Healthy Young Women
This study will observe the participants fasting during the month ramadan. Descriptive characteristics and assessments of sleep, food consumption, body composition, cognitive skills, anticipation time, and physical activity will be conducted before, during and after ramadan.
Read the detailed description
The aim of this is investigating the changes in sleep patterns, dietary intake, cognitive skills, anticipation time and physical activity levels during Ramadan in healthy young women.
After giving information about the research, participants' descriptive characteristics such as age, height, body weight, body fat percentage, and chronotype (Morningness-Eveningness Questionnaire) will be determined and recorded. Participants' sleep patterns (Actigraphy and Pittsburgh Sleep Quality Index), food consumption (BEBIS), cognitive skills (Stroop test, Letter digit test), anticipation time (Bassin Anticipation Timer), and physical activity levels (International Physical Activity Questionnaire) will be assessed before Ramadan (Pre-R), in the first week of Ramadan (FW-R), in the last week of Ramadan (LW-R) and after Ramadan (Post-R). Additionally, body composition measurements will be taken in Pre-R, LW-R and Post-R. The completion of questionnaires and scales will be conducted individually in a quiet environment. Sleep records will be obtained using an actigraphy device in the participants' own sleep environments. Other measurements will be conducted at the University Performance and Exercise Physiology Laboratory under controlled temperature (22-24°C) and humidity (50-60%).
- Conditions
- Fasting, Intermittent, Food Habits, Sleep
- Being tested
- Intermittent Ramadan Fasting
- Keywords
- Physical Fitness, Body Composition, Cognitive Skills, Ramadan Fasting, Anticipation Time
- Medical subject headings
- Intermittent Fasting, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Ramadan FastingOther
Intermittent fasting during the month Ramadan
| Study group | Role | What they receive |
|---|---|---|
| Ramadan Intermittent Fasting Group | Twenty two healthy, moderately active young women who regularly fast during Ramadan. Receives: Other: Intermittent Ramadan Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy
Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Body weight measurement
Test that involves measuring body weight using medical scales
Measured: Pre-test, following one month mid-test and following another one month post-test
Body fat percentage
Includes determination of body fat percentage using a bioelectrical impedance analyzer
Measured: Pre-test, following one month mid-test and following another one month post-test
Food consumption assessment
Participants will be asked to record their food and liquid intake in detail for three consecutive days (two weekdays and one weekend day). All data will then be entered into the nutrition data system, and total energy intake, carbohydrate amount (CHO), protein, fat, and liquid consumption will be calculated.
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Stroop test
The Stroop test reflects mainly the frontal lobe activity. The Stroop effect demonstrates an individual's ability to shift perceptual setup according to changing demands, suppress habitual response patterns, and perform unconventional actions, which are primarily related to frontal lobe activity. The test also measures information processing speed.
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Letter Digit Substitution Test
The Letter Digit Substitution Test is an adapted matching test developed to measure information processing speed. The test contains a key containing nine letters of the alphabet and the numbers 1 to 9. Then there are randomly arranged letters and participants will be asked to match the random letters with the appropriate number indicated by the key.
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Anticipation time measurement
The anticipation time will be measured using the 50575 model of the Bassin Anticipation Timer. The sensitivity of the device will be set to 0.001 seconds, with the anticipation device's speed set to 11 mph (4.9 m/s) and the delay time set to 0-2 seconds. Each participant will undergo 20 measurements per session. Measurements will be manually recorded on the anticipation time measurement sheet.
The test position for all participants will be standing vertically in front of the anticipation device, with the motion light approaching them. The participant will stand at the end of the device, using their dominant hand to press the stop button at sternum height with one hand. The researcher will hide the start command button behind them to ensure participants cannot see when the test begins. After each trial is recorded, the next trial will be conducted. The fixed anticipation time error (SzSh) and absolute anticipation time error (SzMh) will be automatically calculated.
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Physical activity level assessment
The International Physical Activity Questionnaire (IPAQ) will be used to determine their level of physical activity levels. The questionnaire consists of sections that inquire about vigorous physical activity, moderate physical activity, and walking activities of at least 10 minutes duration over the past seven days.
Measured: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Secondary outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index assesses various sleep-related factors, including sleep latency, sleep duration, sleep efficiency, and daytime sleepiness. It is a 19-item self-report questionnaire. Each item is scored from 0 to 3, and the total score ranges from 0 to 57. Higher scores indicate poorer sleep quality.
Measured: Pre-test, following one month mid-test and following another one month post-test
Chronotype assessment
Morningness-Eveningness Questionnaire (MEQ) will be used to assess Chronotype. The form consists of 19 questions, each offering four possible answers. Participants receive different scores based on their responses: questions 3, 4, 5, 6, 7, 8, 9, 13, 14, 15, and 16 are scored between 1 and 4, questions 1, 2, 10, 17, and 18 are scored between 1 and 5, questions 11 and 19 are scored between 0 and 6, and question 12 is scored between 0 and 5. The scores range from 16 to 86, with lower scores indicating evening types and higher scores indicating morning types. Based on the total score, individuals are classified as evening types (16-41 points), intermediate types (42-58 points), and morning types (59-86 points).
Measured: Only once in the pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start23 Feb 2025
- Primary completion15 Mar 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting, IntermittentStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümid Karlı, Abant Izzet Baysal University
- Investigators
- Umid Karli, PhD, Principal investigator, Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865014
- Sponsor's protocol ID
- BAIBU-SBF-UK-02
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Sleep Patterns, Dietary Intake, Cognitive Skills, Anticipation Time and Physical Activity Levels During Ramadan in Healthy Young Women
- ClinicalTrials.gov ID
- NCT06865014
- Acronym / sponsor ID
- BAIBU-SBF-UK-02
- Conditions
- Fasting, Intermittent, Food Habits, Sleep
- Keywords
- Physical Fitness, Body Composition, Cognitive Skills, Ramadan Fasting, Anticipation Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 23 Feb 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will observe the participants fasting during the month ramadan. Descriptive characteristics and assessments of sleep, food consumption, body composition, cognitive skills, anticipation time, and physical activity will be conducted before, during and after ramadan.
Detailed description
The aim of this is investigating the changes in sleep patterns, dietary intake, cognitive skills, anticipation time and physical activity levels during Ramadan in healthy young women.
After giving information about the research, participants' descriptive characteristics such as age, height, body weight, body fat percentage, and chronotype (Morningness-Eveningness Questionnaire) will be determined and recorded. Participants' sleep patterns (Actigraphy and Pittsburgh Sleep Quality Index), food consumption (BEBIS), cognitive skills (Stroop test, Letter digit test), anticipation time (Bassin Anticipation Timer), and physical activity levels (International Physical Activity Questionnaire) will be assessed before Ramadan (Pre-R), in the first week of Ramadan (FW-R), in the last week of Ramadan (LW-R) and after Ramadan (Post-R). Additionally, body composition measurements will be taken in Pre-R, LW-R and Post-R. The completion of questionnaires and scales will be conducted individually in a quiet environment. Sleep records will be obtained using an actigraphy device in the participants' own sleep environments. Other measurements will be conducted at the University Performance and Exercise Physiology Laboratory under controlled temperature (22-24°C) and humidity (50-60%).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramadan Intermittent Fasting Group | – | Other: Intermittent Ramadan FastingTwenty two healthy, moderately active young women who regularly fast during Ramadan. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Twenty two healthy, moderately active young women who regularly fast during the month Ramadan will be the participants in this study.
Key inclusion criteria (5 listed)
- Voluntariness: Participants must be willing to participate in the study voluntarily and provide informed consent.
- Absence of any health issues
- No chronic sleep problems
- No use of sleep medication
- Fasting throughout the study period during the month Ramadan
Key exclusion criteria (2 listed)
- Complications During the Intervention: Participants who experience any complications during the month Ramadan while fasting.
- Irregular fasting behavior during Ramadan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Ramadan FastingIntermittent fasting during the month Ramadan | Other | Ramadan Intermittent Fasting Group |
Primary outcome
Actigraphy
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography
Body weight measurement
Time frame: Pre-test, following one month mid-test and following another one month post-test
Test that involves measuring body weight using medical scales
Body fat percentage
Time frame: Pre-test, following one month mid-test and following another one month post-test
Includes determination of body fat percentage using a bioelectrical impedance analyzer
Food consumption assessment
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Participants will be asked to record their food and liquid intake in detail for three consecutive days (two weekdays and one weekend day). All data will then be entered into the nutrition data system, and total energy intake, carbohydrate amount (CHO), protein, fat, and liquid consumption will be calculated.
Stroop test
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
The Stroop test reflects mainly the frontal lobe activity. The Stroop effect demonstrates an individual's ability to shift perceptual setup according to changing demands, suppress habitual response patterns, and perform unconventional actions, which are primarily related to frontal lobe activity. The test also measures information processing speed.
Letter Digit Substitution Test
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
The Letter Digit Substitution Test is an adapted matching test developed to measure information processing speed. The test contains a key containing nine letters of the alphabet and the numbers 1 to 9. Then there are randomly arranged letters and participants will be asked to match the random letters with the appropriate number indicated by the key.
Anticipation time measurement
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
The anticipation time will be measured using the 50575 model of the Bassin Anticipation Timer. The sensitivity of the device will be set to 0.001 seconds, with the anticipation device's speed set to 11 mph (4.9 m/s) and the delay time set to 0-2 seconds. Each participant will undergo 20 measurements per session. Measurements will be manually recorded on the anticipation time measurement sheet. The test position for all participants will be standing vertically in front of the anticipation device, with the motion light approaching them. The participant will stand at the end of the device, using their dominant hand to press the stop button at sternum height with one hand. The researcher will hide the start command button behind them to ensure participants cannot see when the test begins. After each trial is recorded, the next trial will be conducted. The fixed anticipation time error (SzSh) and absolute anticipation time error (SzMh) will be automatically calculated.
Physical activity level assessment
Time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
The International Physical Activity Questionnaire (IPAQ) will be used to determine their level of physical activity levels. The questionnaire consists of sections that inquire about vigorous physical activity, moderate physical activity, and walking activities of at least 10 minutes duration over the past seven days.
2 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-test, following one month mid-test and following another one month post-test
Chronotype assessment
Time frame: Only once in the pre-test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umid Karli, PhD principal investigator
Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, Intermittent and Food Habits, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphy (time frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.