Intermittent Fasting, Mediterranean Diet and NAFLD (RC2024-21)

October 22, 2024 updated by: Dr. Rosa Reddavide - MSc, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Medium/severe NAFLD (CAP>268)
  • BMI between 25 and 35

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group - Mediterranean diet with low glycemic index
Control group in which patients will follow a Mediterranean diet with a low glycemic index
Experimental: Case group - Intermittent Fasting
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at Baseline and after 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of the intervention on the Body Composition detected with DEXA
Time Frame: at Baseline and after 4 months
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
Time Frame: at Baseline and after 4 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of intervention on routine blood chemistry parameters, relating to nutritional status
Time Frame: at Baseline and after 4 months
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
The effect of intervention on routine blood chemistry parameters, relating to NAFLD
Time Frame: at Baseline and after 4 months

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).
at Baseline and after 4 months
The effect of intervention on routine blood chemistry parameters, relating to fibrosis
Time Frame: at Baseline and after 4 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 18, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC2024-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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