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Completed

NCT Number: NCT06664684

Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

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.

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Key information

Conditions

Intermittent Fasting Behavior Digestive System Diseases Fasting Fatty Liver Feeding Behavior Liver Diseases Metabolic Dysfunction-Associated Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Gastroenterology, Liver Research Unit, Marmara University

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Energy-restricted dietary intervention

Other

The diets were planned based on current guidelines, manuals, systematic reviews, and meta-analyses published in recent years on MAFLD [5-6, 27-28]. In this diet, carbohydrates constituted 50%-55% of total energy intake, proteins constituted 10%-20%, and fats constituted 25%-35%. The content of the diets was tailored to each patient, considering various factors such as sex, age, and physical activity status.

Energy + time-restricted dietary intervention

Other

Patients in the energy + time-restricted diet group followed the same dietary intervention and a 16:8 eating pattern where they were instructed to restrict their energy intake to an 8-h time window and not to consume energy-containing foods or drinks during the remaining 16 h. Participants were allowed to consume energy-free beverages such as water, coffee, and tea during fasting. The timing of the eating window during the day varied according to participants' lifestyles and habits. However, considering the importance of nocturnal fasting, the eating window in all patients started at 10:00-12:00 in the day and ended at 18:00-20:00 in the evening. The energy-restricted diet group did not follow any time restriction in the planning of main meals and snacks.

Primary outcomes

  1. Transient Elastography-Controlled Attenuation Parameter

    Time frame: 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.

  2. Transient Elastography-Liver Stiffness Measurement

    Time frame: 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 outcomes

  1. Serum Fibroblast Growth Factor-21

    Time frame: 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).

  2. Serum Autophagy-Related Protein-5

    Time frame: 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).

  3. Serum Beclin-1

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Istanbul Bilgi University

Other

Collaborators

  • Marmara University

Registry information

Official study title

Effects of Intermittent Fasting in Metabolic Dysfunction Associated Fatty Liver Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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