NAFLDRC2024-21NCT06615817
Intermittent Fasting, Mediterranean Diet and NAFLD
A study testing Intermittent Fasting in people with NAFLD and Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
Trial summary
This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Obesity, Intermittent Fasting
- What is being tested?
- Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medium/severe NAFLD (CAP>268)
- BMI between 25 and 35
Who cannot join
- diabetes treated with insulin,
- fatty liver disease linked to alcohol consumption,
- chronic inflammatory intestinal and oncological diseases,
- visceral obesity which does not allow good resolution of Fibroscan images,
- subjects in serious medical conditions that may compromise participation in the trial,
- people following a special diet or unable to follow a diet for religious or other reasons.
- Pregnancy and breastfeeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ornella Rotolo, Biologyst contact
About this study
Official title: Comparison Between 14/10 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score, Inflammatory Indices and Intestinal Microbiota
This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.
Read the detailed description
Interventional, randomized, controlled 2-arm clinical trial
The two study arms are:
- Low-Glycemic Index Mediterranean Diet (Control Arm).
- IF 14/10 (Experimental Arm) with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet.
The study involves the enrollment of 60 subjects (30 in each arm) with NAFLD, medium/severe grade diagnosed by Fibroscan, randomly assigned using randomization tables to one of the two study arms.
The duration of the nutritional intervention is 4 months. During the study duration period, patients will undergo 3 visits.
At T0 (Screening Visit) patients, who are potentially enrollable, after signing the informed consent, will undergo:
- Medical history (family, physiological, remote and upcoming pathological and pharmacological);
- Fibroscan, to assess the degree of hepatic steatosis;
- Survey of anthropometric characteristics (BMI, abdominal circumference, neck circumference);
- Bioimpedance examination;
- NuWell (Nutrition Wellness Survey) questionnaire completion.
- IPAQ (Daily Physical Activity Questionnaire) questionnaire.
In case the inclusion criteria are met, the enrolled patients will be randomized, using randomization tables, into one of the two arms under the study.
The enrolled patients, will be invited to return after 7 days to complete T0 and receive the personalized food plan, depending on the arm they belong to and anthropometric characteristics.
Fasting for at least 12 hours, they will undergo blood sampling by venipuncture and body composition assessment by DEXA.
Enrolled subjects will be asked to bring a stool sample and a urine sample for fecal and urinary mycriobiota and metabolome analysis.
Patients will be given the Food Diary, which must be reported completed at each visit.
After 2 months from the start of treatment (T0 + 60gg) patients will be called for T1.
At this visit, patients who have been fasting for at least 12 hours will undergo:
- Samples by venous puncture;
- Bioimpedance examination;
- Anthropometric measurements. Patients will be asked to bring a stool sample and a urine sample, and the Food Diary will be checked.
After another 2 months (T1 + 60gg: End of treatment) patients will be called for T2.
At this visit, patients, fasting for at least 12 hours, will undergo:
- Samples by venous puncture;
- Fibroscan
- Bioimpedance examination;
- DEXA
- Anthropometric measurements. Patients will be asked to bring a stool sample and a urine sample, and a Food Diary will be collected.
The blood sample taken will be used to assay routine hematochemical parameters and nutritional, metabolic and cardiovascular risk. Specifically, the following will be assayed: blood glucose, glycated hemoglobin, insulin, azotemia, creatinine, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, urate, AST, ALT, gamma GT, total protein, protein electrophoresis, high-sensitivity PCR, TSH, FT3, FT4, blood count, ferritin, vitamin D, prolactin, cortisol, urine tests, IL 1, 4, 6, 8, 10, CK18 and TNFα.
Patients will be given the reports of Routine blood tests only, Fibroscan, Bioimpedance Examination and DEXA.
- Conditions
- NAFLD, Obesity, Intermittent Fasting, Mediterranean Diet
- Being tested
- Intermittent Fasting
- Keywords
- Obesity, Liver Diseases
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Intermittent Fasting, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingDietary supplement
In this group, a diet based on intermittent fasting will be administered - with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet.
| Study group | Role | What they receive |
|---|---|---|
| Control group - Mediterranean diet with low glycemic index | No intervention | Control group in which patients will follow a Mediterranean diet with a low glycemic index |
| Case group - Intermittent Fasting | Experimental | Intermittent fasting 14/10 with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet. Receives: Dietary Supplement: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of intervention on CAP value
To evaluate the change in hepatic steatosis score after 4 months of a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet.
The cut off to indicate the presence of steatosis is CAP>268. A decrease in the CAP value indicates an improvement in the pathology
Measured: at Baseline and after 4 months
Secondary outcomes (2)
The effect of the intervention on the Body Composition detected with DEXA
Evaluate the change in body composition detected with DEXA after 4 months of a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet
Measured: at Baseline and after 4 months
The effect of the intervention on the Body Composition detected with bioimpedance analysis
Evaluate the change in body composition detected with bioimpedance analysis after 4 months of a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet
Measured: at Baseline and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rosa Reddavide - MSc, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615817
- Sponsor's protocol ID
- RC2024-21
- Acronym
- RC2024-21
- Status last verified
- Oct 2024
- First submitted
- 18 Sep 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zelber-Sagi S, Godos J, Salomone F. Lifestyle changes for the treatment of nonalcoholic fatty liver disease: a review of observational studies and intervention trials. Ther Adv Gastroenterol. 2016 May;9(3):392-407. doi: 10.1177/1756283X16638830. Epub 2016 Mar 17.
PubMed 27134667Laferrere B, Panda S. Calorie and Time Restriction in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1572-1573. doi: 10.1056/NEJMe2202821. No abstract available.
PubMed 35443112Marinac CR, Nelson SH, Breen CI, Hartman SJ, Natarajan L, Pierce JP, Flatt SW, Sears DD, Patterson RE. Prolonged Nightly Fasting and Breast Cancer Prognosis. JAMA Oncol. 2016 Aug 1;2(8):1049-55. doi: 10.1001/jamaoncol.2016.0164.
PubMed 27032109
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 14/10 Intermittent Fasting and the Southern Italian Mediterranean Diet in the Variation of NAFLD Score, Inflammatory Indices and Intestinal Microbiota
- ClinicalTrials.gov ID
- NCT06615817
- Acronym / sponsor ID
- RC2024-21 / RC2024-21
- Conditions
- NAFLD, Obesity, Intermittent Fasting, Mediterranean Diet
- Keywords
- Obesity, Liver Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Sep 2024 (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.
This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.
Detailed description
Interventional, randomized, controlled 2-arm clinical trial
The two study arms are:
- Low-Glycemic Index Mediterranean Diet (Control Arm).
- IF 14/10 (Experimental Arm) with 14 hours of overnight fasting and 10 hours of feeding with Low Glycemic Index Mediterranean Diet.
The study involves the enrollment of 60 subjects (30 in each arm) with NAFLD, medium/severe grade diagnosed by Fibroscan, randomly assigned using randomization tables to one of the two study arms.
The duration of the nutritional intervention is 4 months. During the study duration period, patients will undergo 3 visits.
At T0 (Screening Visit) patients, who are potentially enrollable, after signing the informed consent, will undergo:
- Medical history (family, physiological, remote and upcoming pathological and pharmacological);
- Fibroscan, to assess the degree of hepatic steatosis;
- Survey of anthropometric characteristics (BMI, abdominal circumference, neck circumference);
- Bioimpedance examination;
- NuWell (Nutrition Wellness Survey) questionnaire completion.
- IPAQ (Daily Physical Activity Questionnaire) questionnaire.
In case the inclusion criteria are met, the enrolled patients will be randomized, using randomization tables, into one of the two arms under the study.
The enrolled patients, will be invited to return after 7 days to complete T0 and receive the personalized food plan, depending on the arm they belong to and anthropometric characteristics.
Fasting for at least 12 hours, they will undergo blood sampling by venipuncture and body composition assessment by DEXA.
Enrolled subjects will be asked to bring a stool sample and a urine sample for fecal and urinary mycriobiota and metabolome analysis.
Patients will be given the Food Diary, which must be reported completed at each visit.
After 2 months from the start of treatment (T0 + 60gg) patients will be called for T1.
At this visit, patients who have been fasting for at least 12 hours will undergo:
- Samples by venous puncture;
- Bioimpedance examination;
- Anthropometric measurements. Patients will be asked to bring a stool sample and a urine sample, and the Food Diary will be checked.
After another 2 months (T1 + 60gg: End of treatment) patients will be called for T2.
At this visit, patients, fasting for at least 12 hours, will undergo:
- Samples by venous puncture;
- Fibroscan
- Bioimpedance examination;
- DEXA
- Anthropometric measurements. Patients will be asked to bring a stool sample and a urine sample, and a Food Diary will be collected.
The blood sample taken will be used to assay routine hematochemical parameters and nutritional, metabolic and cardiovascular risk. Specifically, the following will be assayed: blood glucose, glycated hemoglobin, insulin, azotemia, creatinine, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, urate, AST, ALT, gamma GT, total protein, protein electrophoresis, high-sensitivity PCR, TSH, FT3, FT4, blood count, ferritin, vitamin D, prolactin, cortisol, urine tests, IL 1, 4, 6, 8, 10, CK18 and TNFα.
Patients will be given the reports of Routine blood tests only, Fibroscan, Bioimpedance Examination and DEXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - Mediterranean diet with low glycemic index | No intervention | –Control group in which patients will follow a Mediterranean diet with a low glycemic index |
| Case group - Intermittent Fasting | Experimental | Dietary Supplement: Intermittent FastingIntermittent fasting 14/10 with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medium/severe NAFLD (CAP>268)
- BMI between 25 and 35
Key exclusion criteria (7 listed)
- diabetes treated with insulin,
- fatty liver disease linked to alcohol consumption,
- chronic inflammatory intestinal and oncological diseases,
- visceral obesity which does not allow good resolution of Fibroscan images,
- subjects in serious medical conditions that may compromise participation in the trial,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingIn this group, a diet based on intermittent fasting will be administered - with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet. | Dietary supplement | Case group - Intermittent Fasting |
Primary outcome
The effect of intervention on CAP value
Time frame: at Baseline and after 4 months
To evaluate the change in hepatic steatosis score after 4 months of a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet. The cut off to indicate the presence of steatosis is CAP>268. A decrease in the CAP value indicates an improvement in the pathology
2 secondary outcomes
The effect of the intervention on the Body Composition detected with DEXA
Time frame: at Baseline and after 4 months
The effect of the intervention on the Body Composition detected with bioimpedance analysis
Time frame: at Baseline and after 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 27134667Zelber-Sagi S, Godos J, Salomone F. Lifestyle changes for the treatment of nonalcoholic fatty liver disease: a review of observational studies and intervention trials. Ther Adv Gastroenterol. 2016 May;9(3):392-407. doi: 10.1177/1756283X16638830. Epub 2016 Mar 17.
- Background: PubMed 35443112Laferrere B, Panda S. Calorie and Time Restriction in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1572-1573. doi: 10.1056/NEJMe2202821. No abstract available.
- Background: PubMed 27032109Marinac CR, Nelson SH, Breen CI, Hartman SJ, Natarajan L, Pierce JP, Flatt SW, Sears DD, Patterson RE. Prolonged Nightly Fasting and Breast Cancer Prognosis. JAMA Oncol. 2016 Aug 1;2(8):1049-55. doi: 10.1001/jamaoncol.2016.0164.
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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.
Ornella Rotolo, Biologyst contact
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with NAFLD and Obesity, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa Reddavide, Biologyst (0804994387, rosa.reddavide@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of intervention on CAP value (time frame: at Baseline and after 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615817, which also lists 3 linked publications.
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 26 Oct 2024.