Intermittent Fasting, Mediterranean Diet and NAFLD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About this trial
This study aims to evaluate the effects of Intermittent Fasting (IF) 14/10 compared with the Low Glycemic Index Mediterranean Diet on NAFLD.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Medium/severe NAFLD (CAP>268)
BMI between 25 and 35
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Fasting
Dietary supplementIn 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control group - Mediterranean diet with low glycemic indexNo intervention 0 interventions
Group B: Case group - Intermittent FastingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 monthsOther outcomes
1
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 months2
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 months3
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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