- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865014
Cognitive and Psychomotor Skills and Behavioural Changes During Ramadan in Women
Changes in Sleep Patterns, Dietary Intake, Cognitive Skills, Anticipation Time and Physical Activity Levels During Ramadan in Healthy Young Women
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bolu, Turkey, 14030
- Bolu Abant İzzet Baysal University, Faculty of Sport Sciences,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Complications During the Intervention: Participants who experience any complications during the month Ramadan while fasting.
- Irregular fasting behavior during Ramadan
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Ramadan Intermittent Fasting Group
Twenty two healthy, moderately active young women who regularly fast during Ramadan.
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Intermittent fasting during the month Ramadan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Actigraphy
Time Frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography
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Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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Body weight measurement
Time Frame: Pre-test, following one month mid-test and following another one month post-test
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Test that involves measuring body weight using medical scales
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Pre-test, following one month mid-test and following another one month post-test
|
|
Body fat percentage
Time Frame: Pre-test, following one month mid-test and following another one month post-test
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Includes determination of body fat percentage using a bioelectrical impedance analyzer
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Pre-test, following one month mid-test and following another one month post-test
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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
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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.
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Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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Stroop test
Time Frame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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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.
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Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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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
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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.
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Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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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
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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. |
Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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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
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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.
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Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Pre-test, following one month mid-test and following another one month post-test
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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.
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Pre-test, following one month mid-test and following another one month post-test
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Chronotype assessment
Time Frame: Only once in the pre-test
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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).
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Only once in the pre-test
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Umid Karli, PhD, Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BAIBU-SBF-UK-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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