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:
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
(10M:11F) and body mass index (BMI = kg/m2) will be enrolled for the study. Subjects will be
required to practice a 29/30 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 3.5 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 08:00 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 (p.p.m). The 10 p.p.m 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).