Ramadan Fasting, Microbiota and FABP4

NCT06105372 | Unknown DMC

• 1 other identifier: 1969
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermittent Fasting

Keywords

Fasting, Microbiota; Fatty Acid-Binding Proteins

Outcome Measures

Primary Outcomes (13)

• 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 \[body weight (kg) / height2 (m2)\].

  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.

  Pre-procedure, after 4 weeks

• Food consumption record

  Record food consumption for three consecutive days, with one day falling on a weekend

  one week before the procedure and up to 4 weeks

• Microbiota analysis

  Fecal will be collected from participants and total microbiota will be analyzed.

  Pre-procedure, after 4 weeks

• FABP4 analysis

  Blood samples will be collected from participants and FABP4 (ng/L) values will be analyzed and recorded.

  Pre-procedure, after 4 weeks

• CRP analysis

  Blood samples will be collected from participants and CRP(mg/L) will be analyzed and recorded.

  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.

  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.

  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.

  Pre-procedure, after 4 weeks

• Tg analysis

  Blood samples will be collected from participants and Tg (mg/dl) will be analyzed and recorded.

  Pre-procedure, after 4 weeks

• ALT analysis

  Blood samples will be collected from participants and ALT (U/L) will be analyzed and recorded.

  Pre-procedure, after 4 weeks

• AST analysis

  Blood samples will be collected from participants and AST (U/L) will be analyzed and recorded.

  Pre-procedure, after 4 weeks

• GGT analysis

  Blood samples will be collected from participants and GGT (U/L) will be analyzed and recorded.

  Pre-procedure, after 4 weeks

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The sample of the study was determined as 10 volunteer male participants who fasted during the Ramadan and met the inclusion criteria.

You may qualify if:

• 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
• Not having used antibiotics in the last 6 months
• Not using nutritional supplements
• Volunteering to participate in the research

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

OkanU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intermittent Fasting; Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 27, 2023
• Study Start: March 10, 2023
• Primary Completion: April 21, 2023
• Study Completion: May 31, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)