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临床试验/NCT06105372
NCT06105372Enrolling By Invitation不适用

Effects of Ramadan Fasting on the Intestinal Microbiota and Fatty Acid Binding Protein 4 (FABP4) of Individuals

Okan University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
15
试验地点
1
主要终点
LDL-C analysis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

LDL-C analysis

时间窗: 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

时间窗: Pre-procedure, after 4 weeks

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

Food consumption record

时间窗: one week before the procedure and up to 4 weeks

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

FABP4 analysis

时间窗: Pre-procedure, after 4 weeks

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

GGT analysis

时间窗: Pre-procedure, after 4 weeks

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

BMI (kg/cm2)

时间窗: 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 \[body weight (kg) / height2 (m2)\].

HDL-C analysis

时间窗: Pre-procedure, after 4 weeks

Blood samples will be collected from participants and HDL-C (md/dl) will be analyzed and recorded.

Tg analysis

时间窗: Pre-procedure, after 4 weeks

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

Physical activity levels

时间窗: 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.

Microbiota analysis

时间窗: Pre-procedure, after 4 weeks

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

CRP analysis

时间窗: Pre-procedure, after 4 weeks

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

ALT analysis

时间窗: Pre-procedure, after 4 weeks

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

AST analysis

时间窗: Pre-procedure, after 4 weeks

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

次要结局

未报告次要终点

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aylin Seylam Küşümler

Assistant Professor

Okan University

研究点 (1)

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