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This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.
Interventional, randomized, controlled 2-arm clinical trial
The two study arms are:
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:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Baseline and after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Baseline and after 4 months |
| The effect of the intervention on the Body Composition detected with bioimpedance analysis |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of intervention on routine blood chemistry parameters, relating to NAFLD | To evaluate whether a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet can exert favorable effects on the parameters of routine blood tests relating to NAFLD,after 4 months. The regression formula for prediction of NAFLD is based on 6 variables: age (years), BMI(kg/m2), IFG/diabetes, AST/ALT ratio, platelet count and albumin (g/dl). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosa Reddavide, Biologyst | Contact | 0804994387 | rosa.reddavide@irccsdebellis.it | |
| Ornella Rotolo, Biologyst | Contact | ornella.rotolo@irccsdebellis.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27134667 | Background | 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. | |
| 35443112 | Background | Laferrere 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. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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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 |
| at Baseline and after 4 months |
| at Baseline and after 4 months |
| The effect of intervention on routine blood chemistry parameters, relating to fibrosis | To evaluate whether a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet can exert favorable effects on the parameters of routine blood tests relating to fibrosisafter 4 months. We will take into consideration the FIB4 value. The formula for FIB-4 is: Age ([yr] x AST [U/L]) / ((PLT [10(9)/L]) x (ALT [U/L])(1/2)). | at Baseline and after 4 months |
| The effect of intervention on routine blood chemistry parameters, relating to nutritional status | To evaluate whether a low glycemic index Mediterranean diet and 14/10 intermittent fasting with a low glycemic index Mediterranean diet can exert favorable effects on the parameters of routine blood tests relating to nutritional status, after 4 months. | at Baseline and after 4 months |
| 27032109 | Background | Marinac 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |