Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

Not Applicable

Completed

• Conditions: Intermittent Fasting; Metabolic Dysfunction-Associated Fatty Liver Disease

• Registration Number: NCT06664684
• Lead Sponsor: Istanbul Bilgi University

Brief Summary

Previous studies have investigated the effect of different dietary patterns on metabolic dysfunction-associated fatty liver disease (MAFLD), for which lifestyle modification remains the primary treatment. The present study sought to determine the effect of intermittent fasting on anthropometric measurements, fibroblast growth factor (FGF)-21, and autophagy markers including autophagy-related protein (ATG)-5 and BECLIN-1 levels, as well as on hepatic steatosis and fibrosis levels in overweight or obese patients with MAFLD to elucidate the efficacy of intermittent fasting in the management of MAFLD. The study included 48 patients diagnosed with MAFLD. Patients were randomly assigned into two groups: 22 received a dietary treatment involving 22-25 kcal/kg/day of energy for 8 weeks (energy-restricted diet group), and 26 followed the same dietary intervention and a 16:8 pattern (energy + time-restricted diet group). The patients were assessed for various parameters at baseline (T0) and at the end of the week 8 (T8). The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. Serum levels of FGF-21, BECLIN-1, and ATG-5 were determined using enzyme-linked immunosorbent assay.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-23
• Primary Completion: 2023-01-30
• Study Completion: 2023-09-12
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-29
• Results First Submitted: 2025-04-28
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Results First Posted: 2025-06-26
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Diagnosed with MAFLD
• Aged 18-65 years
• BMI ≥ 25 kg/m²
• A stable body weight (<5 kg weight loss or gain) over the last 3 months preceding the start of the study
• Signed the informed consent form.

Exclusion Criteria

• An average daily alcohol consumption >20 g for females and >30 g for males
• Pregnant or lactating women
• Patients with ischemic heart disease or heart failure, chronic inflammatory diseases, chronic viral infections, cancer, moderate-to-severe kidney disease, uncontrolled hypertension, and eating disorders
• Those with a history of bariatric surgery
• Those on insulin due to increased risk of hypoglycemia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transient Elastography-Controlled Attenuation Parameter	Measurements were taken twice baseline and 8 weeks after the intervention.	The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic steatosis was defined using controlled attenuation parameter (CAP). The CAP measurement, which indicates steatosis, ranged between 100 and 400 dB/m.
Transient Elastography-Liver Stiffness Measurement	Measurements were taken twice baseline and 8 weeks after the intervention.	The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. The extent of hepatic steatosis and fibrosis was determined using transient elastography on a FibroScan® device. All FibroScan measurements were performed following the manufacturer's instructions as specified previously. Hepatic fibrosis were defined using liver stiffness measurement (LSM). LSM measurement ranged between 2.5 and 75 kPa.

Secondary Outcome Measures

Name	Time	Method
Serum Fibroblast Growth Factor-21	Measurements were taken baseline before and 8 weeks after the intervention.	At each time point (baseline and week 8), one serum sample was collected per participant. Serum Fibroblast Growth Factor-21 (FGF-21) levels were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human FGF-21 ELISA, Biovendor, Czech Republic).
Serum Autophagy-Related Protein-5	Measurements were taken twice baseline and 8 weeks after the intervention.	At each time point (baseline and week 8), one serum sample was collected per participant. Serum autophagy-related protein-5 (ATG-5) were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human Autophagy protein 5 \[ATG5\] ELISA Kit, MyBioSource, Inc. USA).
Serum Beclin-1	Measurements were taken twice baseline and 8 weeks after the intervention.	At each time point (baseline and week 8), one serum sample was collected per participant. Serum Beclin-1 were analyzed using enzyme-linked immunosorbent assay (ELISA) kits, following the manufacturer's protocols (Human BECN1 \[Beclin 1\] ELISA Kit, ElabScience, USA).

Trial Locations

Locations (1)

Institute of Gastroenterology, Liver Research Unit, Marmara University; 🇹🇷 Istanbul, Turkey