Intermittent Fasting, Mediterranean Diet and NAFLD

NCT ID: NCT06615817

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-01

Brief Summary

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.

Conditions

NAFLD; Obesity; Intermittent Fasting; Mediterranean Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group - Mediterranean diet with low glycemic index

Control group in which patients will follow a Mediterranean diet with a low glycemic index

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Intermittent Fasting

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rosa Reddavide - MSc

Principal Investigator, Biologyst

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rosa Reddavide, Biologyst

Role: CONTACT

rosa.reddavide@irccsdebellis.it

0804994387

Ornella Rotolo, Biologyst

Role: CONTACT

ornella.rotolo@irccsdebellis.it

References

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. Therap Adv Gastroenterol. 2016 May;9(3):392-407. doi: 10.1177/1756283X16638830. Epub 2016 Mar 17.

Reference Type: BACKGROUND

PMID: 27134667 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35443112 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27032109 (View on PubMed)

Other Identifiers

RC2024-21

Identifier Type: -

Identifier Source: org_study_id