Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05571891
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2022-09-15
Brief Title:
Effect of Intermittent Fasting Month of Ramadan on Health
Sponsor:
University of Bari
Organization:
University of Bari
Study Overview
Official Title:
Effect of Intermittent Fasting Month of Ramadan on Health
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAMA1
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
Detailed Description:
The study has been developed as a clinical trial It is expected the signing of the informed consent and authorization to the personal data attached information form - Consent and information GDRP A total of 21 subjects aged between 20 and 60 years homogeneous for sex 10M11F and body mass index BMI kgm2 will be enrolled for the study Subjects will be required to practice a 2930 day religious fast
All subjects will provide two stool samples for 16S rRNA sequencing first at baseline and the second after 30 days of Ramadan for gut microbiota assessment In addition at the beginning of the study subjects will be submitted to complementary and validated semi-quantitative questionnaires to assess the severity frequency and duration of the gastrointestinal symptoms in the month prior to the start of the study the study of gastric and cholecystic motility the assessment of the oro-cecal transit time In addition at the beginning of the study during and after fasting subjects will be complementary and validated semi-quantitative food questionnaires to evaluate the diet
Gastric and cholecystic motility will be assessed using a portable ultrasound scanner Esaote AU450 and Noblus Hitachi Medical Tokyo Japan equipped with a 35 MHz convex probe in order to measure time-dependent changes in fasting and post-meal cholecyst volumes and gastric antral areas All experiments will begin at 0800 after an overnight fast of 12 hours Gastric and cholecyst motility will be compared after the standard meal Nturi ENSUR ingested along with a 120 ml glass of water in which 15 ml of lactulose will be dissolved Lactulose provides a non-absorbable but fermentable substrate useful for measuring the oro-cecal transit time OCTT The solution will be drunk at room temperature for one minute in the presence of the examiner
Transit times will be measured using breath testing following standard guidelines During the 30 days prior to the test subjects should not take antibiotics probiotics prokinetics or other medications that affect gastrointestinal motility and gut microbiota To avoid prolonged intestinal production of H2 due to the presence of non-absorbable or slowly fermentable foods each subject should follow a special diet the day before the test consisting of meat fish and olive oil No other fermentable foods or sugary drinks will be allowed Breath samples will be taken before ingestion of the test meal and then every 15 minutes for 120 minutes after ingestion of the meal using a pre-calibrated portable hydrogen-sensitive electrochemical device EC60-Gastrolyzer Bedfont USA Results will be expressed as excretion of H2 in parts per million ppm The 10 ppm increase from baseline over two consecutive measurements will provide the OCTT for each subject after conversion to minutes
In order to evaluate the impact of Ramadan parameters related to glycemia triglycerides and cholesterol will be evaluated by a blood test Fecal microbiota analysis will be conducted at DISSPA Department of Soil Plant and Food Sciences
All subjects will provide two stool samples for 16S rRNA sequencing first at baseline and the second after 30 days of Ramadan for gut microbiota assessment In addition at the beginning of the study subjects will be submitted to complementary and validated semi-quantitative questionnaires to assess the severity frequency and duration of the gastrointestinal symptoms in the month prior to the start of the study the study of gastric and cholecystic motility the assessment of the oro-cecal transit time In addition at the beginning of the study during and after fasting subjects will be complementary and validated semi-quantitative food questionnaires to evaluate the diet
Gastric and cholecystic motility will be assessed using a portable ultrasound scanner Esaote AU450 and Noblus Hitachi Medical Tokyo Japan equipped with a 35 MHz convex probe in order to measure time-dependent changes in fasting and post-meal cholecyst volumes and gastric antral areas All experiments will begin at 0800 after an overnight fast of 12 hours Gastric and cholecyst motility will be compared after the standard meal Nturi ENSUR ingested along with a 120 ml glass of water in which 15 ml of lactulose will be dissolved Lactulose provides a non-absorbable but fermentable substrate useful for measuring the oro-cecal transit time OCTT The solution will be drunk at room temperature for one minute in the presence of the examiner
Transit times will be measured using breath testing following standard guidelines During the 30 days prior to the test subjects should not take antibiotics probiotics prokinetics or other medications that affect gastrointestinal motility and gut microbiota To avoid prolonged intestinal production of H2 due to the presence of non-absorbable or slowly fermentable foods each subject should follow a special diet the day before the test consisting of meat fish and olive oil No other fermentable foods or sugary drinks will be allowed Breath samples will be taken before ingestion of the test meal and then every 15 minutes for 120 minutes after ingestion of the meal using a pre-calibrated portable hydrogen-sensitive electrochemical device EC60-Gastrolyzer Bedfont USA Results will be expressed as excretion of H2 in parts per million ppm The 10 ppm increase from baseline over two consecutive measurements will provide the OCTT for each subject after conversion to minutes
In order to evaluate the impact of Ramadan parameters related to glycemia triglycerides and cholesterol will be evaluated by a blood test Fecal microbiota analysis will be conducted at DISSPA Department of Soil Plant and Food Sciences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None