NCT06615817

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

September 18, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

September 18, 2024

Last Update Submit

October 22, 2024

Conditions

NAFLDObesityIntermittent FastingMediterranean Diet

Keywords

ObesityLiver Diseases

Outcome Measures

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

    at Baseline and after 4 months

Secondary Outcomes (2)

  • The effect of the intervention on the Body Composition detected with DEXA

    at Baseline and after 4 months

  • The effect of the intervention on the Body Composition detected with bioimpedance analysis

    at Baseline and after 4 months

Other Outcomes (3)

  • The effect of intervention on routine blood chemistry parameters, relating to NAFLD

    at Baseline and after 4 months

  • The effect of intervention on routine blood chemistry parameters, relating to fibrosis

    at Baseline and after 4 months

  • The effect of intervention on routine blood chemistry parameters, relating to nutritional status

    at Baseline and after 4 months

Study Arms (2)

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.

Dietary Supplement: Intermittent Fasting

Interventions

Intermittent FastingDIETARY_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.

Case group - Intermittent Fasting

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27134667BACKGROUND

  • 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.

    PMID: 35443112BACKGROUND

  • 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.

    PMID: 27032109BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityIntermittent FastingLiver Diseases

Condition Hierarchy (Ancestors)

Fatty LiverDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Central Study Contacts

Rosa Reddavide, Biologyst

CONTACT

0804994387rosa.reddavide@irccsdebellis.it

Ornella Rotolo, Biologyst

CONTACT

ornella.rotolo@irccsdebellis.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Biologyst

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 27, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

October 26, 2024

Record last verified: 2024-10