Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06105372 |
| Other study ID # |
1969 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2023 |
| Est. completion date |
May 31, 2024 |
Study information
| Verified date |
October 2023 |
| Source |
Okan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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;
1. Gut microbiota composition of adult individuals differs before and after Ramadan
fasting.
2. Serum FABP4 and other biochemical values of adult individuals differ before and after
Ramadan fasting.
3. 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.
