N/A N=55 Randomized Single-blind Treatment

Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

Intermittent Fasting · Metabolic Dysfunction-Associated Fatty Liver Disease

Bottom Line

View on ClinicalTrials.gov: NCT06664684 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2025

Primary outcome: Primary: Transient Elastography-Controlled Attenuation Parameter — 319.5; 343.5; 291.5; 285.0 db/m

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Energy-restricted dietary intervention (Other); Energy + time-restricted dietary intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Istanbul Bilgi University
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Transient Elastography-Controlled Attenuation Parameter	319.5; 343.5; 291.5; 285.0	—
PRIMARY Transient Elastography-Liver Stiffness Measurement	5.5; 5.7; 5.1; 4.8	—
SECONDARY Serum Fibroblast Growth Factor-21	316.9; 371.4; 278.1; 199.1	—
SECONDARY Serum Autophagy-Related Protein-5	0.67; 0.74; 0.82; 0.95	—
SECONDARY Serum Beclin-1	0.18; 0.18; 0.19; 0.19	—

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.

Eligibility Criteria

Inclusion Criteria

Diagnosed with MAFLD
Aged 18-65 years
BMI ≥ 25 kg/m²
A stable body weight ( 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.

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Data sourced from ClinicalTrials.gov (NCT06664684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.