An interventional study of Intermittent Fasting in NAFLD, Obesity and Intermittent Fasting, sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Not yet recruiting. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Not applicable, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis is the lead sponsor of 54 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Control group in which patients will follow a Mediterranean diet with a low glycemic index
Intermittent fasting 14/10 with 14 hours of nocturnal fasting and 10 hours of feeding with a low glycemic index Mediterranean diet.
Dietary Supplement: Intermittent Fasting
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.
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
Time frame: at Baseline and after 4 months
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
Time frame: 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
Time frame: at Baseline and after 4 months
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).
Time frame: 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)).
Time frame: 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.
Time frame: at Baseline and after 4 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis