Effect of Intermittent Fasting (Month of Ramadan) on Health

NCT05571891 | Completed

• 1 other identifier: RAMA-1 2022
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, many studies have shown the positive effect of certain types of fasting on human health, particularly on obesity, diabetes, and aging. In particular, the beneficial effects of intermittent fasting are gaining more attention among clinical researchers. Intermittent fasting is the voluntary abstinence of individuals, from food (some or all food, drinks, or both) for a period longer than a typical overnight 12 h fast. The digestibility of food is an important characteristic, associated with the concepts of health and well-being. Digestive motility disorder leads to various digestive problems like difficulty in swallowing, acid reflux disease, severe constipation, diarrhea, abdominal pain, vomiting, and bloating. Hence the investigators aimed to assess the impact of intermittent fasting (religious fasting "Ramadan") on digestibility (gastrointestinal motility), weight, blood glucose level, gut microbiota, and gut permeability of the subjects. A cohort of 21 subjects homogeneously distributed by sex, age, and BMI will be prospectively enrolled and involved in the study. By comparing the analytical data before and after Ramadan the effect of intermittent fasting on digestibility, blood glucose and microbiota will be characterized by the investigators.

Conditions

Fasting, Intermittent

Outcome Measures

Primary Outcomes (5)

• Effect of intermittent fasting on anthropometric measurements

  height and weight will be combined to calculate Body Mass Index (BMI, expressed as Kg/m\^2). measurements will be recorded in all subjects at enrollment and at the end of the intermittent fasting

  1 months

• Effect of intermittent fasting on gastric intestinal motility

  The gastric and cholecystic motility was assessed by ultra sound scanner and the severity, frequency and duration of gastrointestinal symptoms was using the questionnaires before and after the intermittent fasting

  1 month

• Effect of intermittent fasting on gut microbiome

  Analysis of the gut microbiome by DNA extraction from faecal samples and high-throughput rRNA gene-targeted amplicon sequencing Gut metabolome: Faecal samples will be analysed by GC-MS and 1H-NMR. Faecal SCFA will be also analysed.

  1 month

• Effect of intermittent fasting on visceral and subcutaneous fat quantity and deposition

  The visceral fat (VAT) and subcutaneous fat (SAT) deposition on different parts of the body such as pre-hepatic, pre-pancriatic, pre-aortic, hepato-renal, and spleno-renal fats will be analysed by ultrasound ecography. The amount of SAT and VAT will be expressed in mm before and after intermittent fasting.

  1 month

• Effect of intermittent fasting on serum gluco-lipid profile

  Serum glucose (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), HDL cholesterol (mg/dL), triglycerides (mg/dL) will be measured at enrollment and at the end of the intermittent fasting.

  1 month

Eligibility Criteria

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

Study Population

For this pilot study 21 subjects homogeneously distributed by sex, age and BMI will be involved. The subjects will be required to practice religious fasting (Ramadan fasting) for 29/30 days.

You may qualify if:

• Subjects able to provide informed consent
• Age between 20 and 60
• Healthy Volunteers

You may not qualify if:

• Lack of informed consent
• Diagnosis of organic diseases, including neoplastic inflammatory diseases or cardiovascular diseases
• Medications that can affect the gastrointestinal tract and interfere with symptoms
• Pregnancy
• Presence of diseases with a prognosis of less than 12 months
• Celiac disease

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"

Bari, BA, 70124, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample collected for metabolic analysis

MeSH Terms

Conditions

Intermittent Fasting

Condition Hierarchy (Ancestors)

Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• 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: September 15, 2022
• First Posted: October 7, 2022
• Study Start: March 15, 2022
• Primary Completion: April 15, 2022
• Study Completion: May 1, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

IT (1)