Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05571891
Other study ID # RAMA-1 2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date May 1, 2022

Study information

Verified date October 2022
Source University of Bari
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri" Bari BA

Sponsors (1)

Lead Sponsor Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06376604 - Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies N/A
Recruiting NCT04503005 - Fasting Time Effects in Time-Restricted Eating (FaTE-TRE) N/A
Active, not recruiting NCT05827965 - Ramadan Fasting in Secondary Adrenal Insufficiency Patients N/A
Recruiting NCT04477590 - Interactions of Medicine and Exercise With Meal Timing N/A
Recruiting NCT05256888 - Time-Restricted Eating to Address Persistent Cancer-Related Fatigue N/A
Recruiting NCT05658991 - Electrophysiological Changes With Diet. N/A