Gut Microbiota and Intestinal Permeability Responses to Ramadan Intermittent Fasting in Italian and Lebanese Cohorts: a Real-life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Changes in Intestinal Permeability Markers
研究概览
简要总结
Ramadan Intermittent Fasting (RIF) is an annual fasting month from dawn to sunset, practiced by healthy Muslims. While its metabolic benefits are well studied, its effects on the gastrointestinal (GI) tract, intestinal permeability, and GI microbiota remain less explored. This study investigated the effects of RIF on gut microbiota composition and markers of intestinal permeability in two distinct populations, i.e., Italy and Lebanon. Participants from Italy and Lebanon were enrolled in this observational longitudinal study and were monitored before, during, and after RIF. Dietary intake was assessed through a validated 3-day food questionnaire before and during RIF. Blood and fecal samples were collected to analyze the markers of intestinal permeability (zonulin, lipopolysaccharide (LPS), Fatty Acid Binding Protein 2 (FABP2), and total bile acids (TBA), and gut microbiota composition using the 16S rRNA gene sequencing.
详细描述
The study has been developed as a clinical trial. It is expected the signing of the informed consent and authorization to the personal data. A total of 79 subjects aging between 20 and 60 years, homogeneous for sex and body mass index were enrolled in the study. Subjects were required to practice a 29/30 days of religeous fasting.
Blood and fecal samples collected before RIF were obtained during the three days preceding RIF (days -3 to -1), whereas samples collected after RIF were obtained during the three days following the end of RIF. Blood samples were analyzed for markers of intestinal permeability, and fecal samples were used for gastrointestinal microbiome analysis. Moreover, each participant completed a validated dietary assessment using a 3-day food record questionnaire, administered during the three days immediately preceding RIF (days -3, -2, -1) and again during RIF (days 14, 15, and 16).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects able to provide signed consent
- •age between 20-60 years
- •Healthy Volunteers
排除标准
- •Lack of informed consent
- •pregnancy
- •celiac disease
- •diagnosis of organic diseases, cardiovascular risk
- •medications that can affect the gastrointestinal tract and interfere with symptoms
研究组 & 干预措施
Italian group
Muslims in Italy
Lebanese Group
Muslims in Lebanon
结局指标
主要结局
Changes in Intestinal Permeability Markers
时间窗: One month
Zonulin and LPS levels were measured through ELISA experiments where blood serum was collected from patients before and after the ending of the fasting month.
次要结局
- Effect of RIF on Gut Microbiota Composition(1 month)
研究者
piero portincasa
Piero Portincasa , MD, PhD, Dr honoris. Causa ., AGAF Professor of internal medicine Chief, Clinica Medica "A. Murri" Director, Dept. Biomedical Sciences & Human Oncology
University of Bari