NCT06865014

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

20 days

First QC Date

March 4, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

Physical FitnessBody CompositionCognitive SkillsRamadan FastingAnticipation Time

Outcome Measures

Primary Outcomes (8)

  • Actigraphy

    Actigraphy is a less invasive method compared to other sleep measurement methods such as polysomnography

    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

    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

    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.

    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.

    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.

    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.

    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.

    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)

    Pre-test, following one month mid-test and following another one month post-test

  • Chronotype assessment

    Only once in the pre-test

Study Arms (1)

Ramadan Intermittent Fasting Group

Twenty two healthy, moderately active young women who regularly fast during Ramadan.

Other: Intermittent Ramadan Fasting

Interventions

Intermittent fasting during the month Ramadan

Ramadan Intermittent Fasting Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study will focus on female participants.
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twenty two healthy, moderately active young women who regularly fast during the month Ramadan will be the participants in this study.

You may qualify if:

  • 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

You may not qualify if:

  • Complications During the Intervention: Participants who experience any complications during the month Ramadan while fasting.
  • Irregular fasting behavior during Ramadan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Sport Sciences,

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intermittent FastingFeeding Behavior

Condition Hierarchy (Ancestors)

FastingBehaviorBehavior, Animal

Study Officials

  • Umid Karli, PhD

    Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 7, 2025

Study Start

February 23, 2025

Primary Completion

March 15, 2025

Study Completion

May 10, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations