Intermittent FastingNCT06105372
Ramadan Fasting, Microbiota and FABP4
An observational study of Intermittent Fasting, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
This study, which aims to examine the effect of Ramadan fasting on intestinal microbiota composition and FABP4, was designed as a quasi-experimental study. This study is planned to be conducted with volunteer participants who fasted during the Ramadan and met the inclusion criteria. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intermittent Fasting
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2023to 31 May 2024
- How long will I take part?
- 2 Months
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The sample of the study was determined as 10 volunteer male participants who fasted during the Ramadan and met the inclusion criteria.
Who may be able to join
- Not having a chronic disease diagnosed by a doctor (DM, hypertension, dyslipidemia, cancer, chronic renal failure, GI problems, etc.)
- Being a male between the ages of 20-50
- Body mass index (BMI) > 18.5 and < 34.9 kg/m2
- Not drinking alcohol
- Not having applied any diet program in the last 6 months
- Not taking prebiotic or probiotic supplements in the last 6 months
Show all 9Show fewer
- Not having used antibiotics in the last 6 months
- Not using nutritional supplements
- Volunteering to participate in the research
Who cannot join
- Women will not be included in the study due to the fact that they will not be able to fast the entire Ramadan fast due to menstruation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Ramadan Fasting on the Intestinal Microbiota and Fatty Acid Binding Protein 4 (FABP4) of Individuals
This study, which aims to examine the effect of Ramadan fasting on intestinal microbiota composition and FABP4, was designed as a quasi-experimental study.
This study is planned to be conducted with volunteer participants who fasted during the Ramadan and met the inclusion criteria.
Read the detailed description
The sample of the study was determined as 10 volunteer male participants who fasted during the Ramadan and met the inclusion criteria. Participants will not be subjected to any energy restriction, they will be fed ad-libitum and only the effect of intermittent fasting and fasting time on the variables will be examined.
Intermittent fasting is supported by increasing studies showing that it has a purifying effect on health. In particular, fasting practices exceeding 16 hours induce autophagy at the cellular level and this continues its effect in all tissue and organ systems after the regeneration movement that starts at the cellular level.
One of the important factors affected by intermittent fasting is the changes in microbiota, which is closely related to the general health of humans. Microbiota is generally defined as the colonization of certain places in our body by various populations of microorganisms and is affected by many factors such as nutrition, lifestyle, exercise, drug use and stress.
Fatty acid binding protein 4 (FABP4) is an adipocyte member of the fatty acid binding protein (FABP) family with nine different isoforms. It is highly secreted from adipose tissue but is also expressed from monocytes, macrophages and dendritic cells. This adipocyte, which increases in obesity, is found at higher levels in women than in men. Studies have shown that increased serum FABP4 levels are associated with Type 1 and Type 2 diabetes mellitus (DM), insulin resistance, and cardiovascular diseases.
The aim of this thesis study was to investigate the effect of Ramadan fasting on gut microbiota and FABP4.
The hypotheses of the study were;
- Gut microbiota composition of adult individuals differs before and after Ramadan fasting.
- Serum FABP4 and other biochemical values of adult individuals differ before and after Ramadan fasting.
- Anthropometric measurements of adults differ before and after Ramadan fasting. All individuals who meet the inclusion and exclusion criteria and agree to participate in the study will be read and signed the Informed Voluntary Consent Form and a copy will be delivered to them. Questions related to the socio-demographic status and dietary habits of all participants will be asked to them and recorded in the questionnaire form by the researcher using the face-to-face interview technique.
Information about the volunteers who participated in the study, such as not having any disease (DM, hypertension, dyslipidemia, cancer, chronic renal failure, GI problems, etc.), not taking medication, and not having used antibiotics in the last six months, were evaluated by the Specialist Dr. who took part in the study. Dr. evaluated the participants through a preliminary interview with the participants. Factors such as the fact that the volunteers who participated in the study did not drink alcohol, had not applied for any diet program in the last six months, whether the participants were doing sahur or not, and especially that all participants had the same duration of fasting during the day during Ramadan were evaluated by the researcher through a preliminary interview with the participants. All individuals who met the inclusion and exclusion criteria and agreed to participate in the study were read and signed the Informed Voluntary Consent Form and a copy was delivered to them.
In order to evaluate the nutritional status of the individuals, the participants will be asked to record the amount of food consumption one week before the start of Ramadan fasting and during the last week of Ramadan for three consecutive days, one day of which will coincide with the weekend, and what should be considered during recording will be explained with examples in advance.
A physical activity record form will be filled out to determine the 24-hour physical activity status of the individuals included in the study and daily energy expenditure will be calculated.
With the start of the study, all participants will be asked about their food consumption records for 3 days (2 days on weekdays + 1 day on weekends), anthropometric measurements (body weight, height, waist circumference, hip circumference) and 24-hour physical activity records one week before the start of Ramadan fasting and the last week of Ramadan.
One day before and on the last day of Ramadan fasting, fecal and blood samples will be collected and total microbiota, FABP4, CRP, fasting insulin, fasting blood glucose, HDL-C, LDL-C, Total-C, TG, ALT, AST and GGT values will be analyzed and recorded.
Descriptive statistics will be given as number and percentage for categorical variables and arithmetic mean and standard deviation for continuous variables. Chi-square test will be used to compare categorical variables. Whether the research data are suitable for normal distribution or not will be tested with Kolmogorov-Smirnov analysis method, and when parametric test assumptions are met in the comparison of independent group differences, t test and Analysis of Variance will be used in independent groups; Mann-Whitney U test and Kruskal Wallis tests will be used when parametric test assumptions are not met. In the comparison of dependent groups, if parametric assumptions are met, t test and repeated measures analysis of variance will be used; Wilcoxon test and Friedman test will be used when parametric test assumptions are not met. Statistical significance level p<0.05 will be accepted.
- Conditions
- Intermittent Fasting
- Keywords
- Fasting, Microbiota, Fatty Acid-Binding Proteins
- Medical subject headings
- Intermittent Fasting, Fasting
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (kg/cm2)
After measuring the body weight (kg) and height (m) of the individuals participating in the study, BMI (kg/m2) values will be calculated; weight and height will be combined to report BMI in kg/m^2 according to the formula [body weight (kg) / height2 (m2)].
Measured: Pre-procedure, after 4 weeks
Physical activity levels
In the calculation of physical activity levels, the equation [(Physical activity rate (PAR) for Activity Type x Duration of Activity (hours)) / (total duration (1440)] will be used.
Measured: Pre-procedure, after 4 weeks
Food consumption record
Record food consumption for three consecutive days, with one day falling on a weekend
Measured: one week before the procedure and up to 4 weeks
Microbiota analysis
Fecal will be collected from participants and total microbiota will be analyzed.
Measured: Pre-procedure, after 4 weeks
FABP4 analysis
Blood samples will be collected from participants and FABP4 (ng/L) values will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
CRP analysis
Blood samples will be collected from participants and CRP(mg/L) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
HDL-C analysis
Blood samples will be collected from participants and HDL-C (md/dl) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
LDL-C analysis
Blood samples will be collected from participants and LDL-C (md/dl) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
Total-C analysis
Blood samples will be collected from participants and Total-C (mg/dl) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
Tg analysis
Blood samples will be collected from participants and Tg (mg/dl) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
ALT analysis
Blood samples will be collected from participants and ALT (U/L) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
AST analysis
Blood samples will be collected from participants and AST (U/L) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
GGT analysis
Blood samples will be collected from participants and GGT (U/L) will be analyzed and recorded.
Measured: Pre-procedure, after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start10 Mar 2023
- Primary completion21 Apr 2023
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent FastingStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Seylam Küşümler, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105372
- Sponsor's protocol ID
- 1969
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramadan Fasting on the Intestinal Microbiota and Fatty Acid Binding Protein 4 (FABP4) of Individuals
- ClinicalTrials.gov ID
- NCT06105372
- Acronym / sponsor ID
- 1969
- Conditions
- Intermittent Fasting
- Keywords
- Fasting, Microbiota, Fatty Acid-Binding Proteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 27 Oct 2023 (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, which aims to examine the effect of Ramadan fasting on intestinal microbiota composition and FABP4, was designed as a quasi-experimental study.
This study is planned to be conducted with volunteer participants who fasted during the Ramadan and met the inclusion criteria.
Detailed description
The sample of the study was determined as 10 volunteer male participants who fasted during the Ramadan and met the inclusion criteria. Participants will not be subjected to any energy restriction, they will be fed ad-libitum and only the effect of intermittent fasting and fasting time on the variables will be examined.
Intermittent fasting is supported by increasing studies showing that it has a purifying effect on health. In particular, fasting practices exceeding 16 hours induce autophagy at the cellular level and this continues its effect in all tissue and organ systems after the regeneration movement that starts at the cellular level.
One of the important factors affected by intermittent fasting is the changes in microbiota, which is closely related to the general health of humans. Microbiota is generally defined as the colonization of certain places in our body by various populations of microorganisms and is affected by many factors such as nutrition, lifestyle, exercise, drug use and stress.
Fatty acid binding protein 4 (FABP4) is an adipocyte member of the fatty acid binding protein (FABP) family with nine different isoforms. It is highly secreted from adipose tissue but is also expressed from monocytes, macrophages and dendritic cells. This adipocyte, which increases in obesity, is found at higher levels in women than in men. Studies have shown that increased serum FABP4 levels are associated with Type 1 and Type 2 diabetes mellitus (DM), insulin resistance, and cardiovascular diseases.
The aim of this thesis study was to investigate the effect of Ramadan fasting on gut microbiota and FABP4.
The hypotheses of the study were;
- Gut microbiota composition of adult individuals differs before and after Ramadan fasting.
- Serum FABP4 and other biochemical values of adult individuals differ before and after Ramadan fasting.
- Anthropometric measurements of adults differ before and after Ramadan fasting. All individuals who meet the inclusion and exclusion criteria and agree to participate in the study will be read and signed the Informed Voluntary Consent Form and a copy will be delivered to them. Questions related to the socio-demographic status and dietary habits of all participants will be asked to them and recorded in the questionnaire form by the researcher using the face-to-face interview technique.
Information about the volunteers who participated in the study, such as not having any disease (DM, hypertension, dyslipidemia, cancer, chronic renal failure, GI problems, etc.), not taking medication, and not having used antibiotics in the last six months, were evaluated by the Specialist Dr. who took part in the study. Dr. evaluated the participants through a preliminary interview with the participants. Factors such as the fact that the volunteers who participated in the study did not drink alcohol, had not applied for any diet program in the last six months, whether the participants were doing sahur or not, and especially that all participants had the same duration of fasting during the day during Ramadan were evaluated by the researcher through a preliminary interview with the participants. All individuals who met the inclusion and exclusion criteria and agreed to participate in the study were read and signed the Informed Voluntary Consent Form and a copy was delivered to them.
In order to evaluate the nutritional status of the individuals, the participants will be asked to record the amount of food consumption one week before the start of Ramadan fasting and during the last week of Ramadan for three consecutive days, one day of which will coincide with the weekend, and what should be considered during recording will be explained with examples in advance.
A physical activity record form will be filled out to determine the 24-hour physical activity status of the individuals included in the study and daily energy expenditure will be calculated.
With the start of the study, all participants will be asked about their food consumption records for 3 days (2 days on weekdays + 1 day on weekends), anthropometric measurements (body weight, height, waist circumference, hip circumference) and 24-hour physical activity records one week before the start of Ramadan fasting and the last week of Ramadan.
One day before and on the last day of Ramadan fasting, fecal and blood samples will be collected and total microbiota, FABP4, CRP, fasting insulin, fasting blood glucose, HDL-C, LDL-C, Total-C, TG, ALT, AST and GGT values will be analyzed and recorded.
Descriptive statistics will be given as number and percentage for categorical variables and arithmetic mean and standard deviation for continuous variables. Chi-square test will be used to compare categorical variables. Whether the research data are suitable for normal distribution or not will be tested with Kolmogorov-Smirnov analysis method, and when parametric test assumptions are met in the comparison of independent group differences, t test and Analysis of Variance will be used in independent groups; Mann-Whitney U test and Kruskal Wallis tests will be used when parametric test assumptions are not met. In the comparison of dependent groups, if parametric assumptions are met, t test and repeated measures analysis of variance will be used; Wilcoxon test and Friedman test will be used when parametric test assumptions are not met. Statistical significance level p<0.05 will be accepted.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample of the study was determined as 10 volunteer male participants who fasted during the Ramadan and met the inclusion criteria.
Key inclusion criteria (9 listed)
- Not having a chronic disease diagnosed by a doctor (DM, hypertension, dyslipidemia, cancer, chronic renal failure, GI problems, etc.)
- Being a male between the ages of 20-50
- Body mass index (BMI) > 18.5 and < 34.9 kg/m2
- Not drinking alcohol
- Not having applied any diet program in the last 6 months
Key exclusion criteria (1 listed)
- Women will not be included in the study due to the fact that they will not be able to fast the entire Ramadan fast due to menstruation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI (kg/cm2)
Time frame: Pre-procedure, after 4 weeks
After measuring the body weight (kg) and height (m) of the individuals participating in the study, BMI (kg/m2) values will be calculated; weight and height will be combined to report BMI in kg/m^2 according to the formula [body weight (kg) / height2 (m2)].
Physical activity levels
Time frame: Pre-procedure, after 4 weeks
In the calculation of physical activity levels, the equation [(Physical activity rate (PAR) for Activity Type x Duration of Activity (hours)) / (total duration (1440)] will be used.
Food consumption record
Time frame: one week before the procedure and up to 4 weeks
Record food consumption for three consecutive days, with one day falling on a weekend
Microbiota analysis
Time frame: Pre-procedure, after 4 weeks
Fecal will be collected from participants and total microbiota will be analyzed.
FABP4 analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and FABP4 (ng/L) values will be analyzed and recorded.
CRP analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and CRP(mg/L) will be analyzed and recorded.
HDL-C analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and HDL-C (md/dl) will be analyzed and recorded.
LDL-C analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and LDL-C (md/dl) will be analyzed and recorded.
Total-C analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and Total-C (mg/dl) will be analyzed and recorded.
Tg analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and Tg (mg/dl) will be analyzed and recorded.
ALT analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and ALT (U/L) will be analyzed and recorded.
AST analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and AST (U/L) will be analyzed and recorded.
GGT analysis
Time frame: Pre-procedure, after 4 weeks
Blood samples will be collected from participants and GGT (U/L) will be analyzed and recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intermittent Fasting, run by Okan 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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
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?
BMI (kg/cm2) (time frame: Pre-procedure, after 4 weeks). The study lists 13 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 27 Oct 2023.