Intermittent Fasting and Metabolic Dysfunction Associated Fatty Liver Disease

Istanbul Bilgi University

Status: Completed

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

Treatments: Other: Energy-restricted dietary intervention; Other: Energy + time-restricted dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06664684

24172

MAFLDIF

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Energy-restricted diet

Active Comparator group

Description:

The energy-restricted diet group followed an 8-week long dietary treatment involving 22-25 kcal/kg/day based on ideal body weight.

Treatment:

Other: Energy-restricted dietary intervention

Energy + time-restricted diet

Experimental group

Description:

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.

Treatment:

Other: Energy + time-restricted dietary intervention