Fasting, IntermittentRAMA1NCT05571891
Effect of Intermittent Fasting (Month of Ramadan) on Health
An observational study of Fasting, Intermittent, run by University of Bari at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting, Intermittent
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2022to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Subjects able to provide informed consent
- Age between 20 and 60
- Healthy Volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences and Human Oncology - Clinica medica "A. Murri"
Bari, BA, 70124
About this study
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.
Read the 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 (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).
- Conditions
- Fasting, Intermittent
- Medical subject headings
- Intermittent Fasting
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start15 Mar 2022
- Primary completion15 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting, IntermittentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571891
- Sponsor's protocol ID
- RAMA-1 2022
- Acronym
- RAMA1
- Status last verified
- Oct 2022
- First submitted
- 15 Sep 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Fasting (Month of Ramadan) on Health
- ClinicalTrials.gov ID
- NCT05571891
- Acronym / sponsor ID
- RAMA1 / RAMA-1 2022
- Conditions
- Fasting, Intermittent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Subjects able to provide informed consent
- Age between 20 and 60
- Healthy Volunteers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of intermittent fasting on anthropometric measurements
Time frame: 1 months
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
Effect of intermittent fasting on gastric intestinal motility
Time frame: 1 month
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
Effect of intermittent fasting on gut microbiome
Time frame: 1 month
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.
Effect of intermittent fasting on visceral and subcutaneous fat quantity and deposition
Time frame: 1 month
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.
Effect of intermittent fasting on serum gluco-lipid profile
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting, Intermittent, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of intermittent fasting on anthropometric measurements (time frame: 1 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.