Gut Microbiota and Intestinal Permeability Responses to Ramadan Intermittent Fasting in Italian and Lebanese Cohorts: a Real-life Study

NCT07596875 | Completed

• 1 other identifier: RAMA3
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ramadan Fasting; Intermittent Islamic Fasting in Metabolic Syndrome

Keywords

Ramadan intermittent fasting; Microbiota; Intestinal permeability

Outcome Measures

Primary Outcomes (1)

• Changes in Intestinal Permeability Markers

  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.

  One month

Secondary Outcomes (1)

• Effect of RIF on Gut Microbiota Composition

  1 month

Study Arms (2)

Italian group

Muslims in Italy

Lebanese Group

Muslims in Lebanon

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

should be muslims in which they are able to do one month of fasting without complications

You may qualify if:

• subjects able to provide signed consent
• age between 20-60 years
• Healthy Volunteers

You may not qualify if:

• Lack of informed consent
• pregnancy
• celiac disease
• diagnosis of organic diseases, cardiovascular risk
• medications that can affect the gastrointestinal tract and interfere with symptoms

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Department of Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (2)

• Khalil M, Abdallah H, Jaber N, Garruti G, Di Ciaula A, Portincasa P. Distinct biophysiological effects of Ramadan fasting and traditional intermittent fasting on markers of body fat storage. A real-life study. Eur J Intern Med. 2024 Nov;129:111-120. doi: 10.1016/j.ejim.2024.08.014. Epub 2024 Aug 26.

  PMID: 39191620 BACKGROUND

• Abdallah H, Khalil M, Farella I, JohnBritto JS, Lanza E, Santoro S, Garruti G, Portincasa P, Di Ciaula A, Bonfrate L. Ramadan intermittent fasting reduces visceral fat and improves gastrointestinal motility. Eur J Clin Invest. 2023 Sep;53(9):e14029. doi: 10.1111/eci.14029. Epub 2023 May 19.

  PMID: 37203871 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples were collected for intestinal permeability analysis

Study Officials

• Piero Portincasa

  Department of Precision and Regenerative Medicine and Ionian Area (DiMePre-J) University of Bari 'Aldo Moro'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Piero Portincasa , MD, PhD, Dr honoris. Causa ., AGAF Professor of internal medicine Chief, Clinica Medica "A. Murri" Director, Dept. Biomedical Sciences & Human Oncology

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: March 11, 2024
• Primary Completion: April 9, 2024
• Study Completion: May 1, 2024
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

IT (1)