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Establishment of a database of Metabolic dysfunction-associated fatty liver disease (MAFLD) and intermittent fasting regimen intervention

Effects of different intermittent fasting intervention in metabolic dysfunction-associated fatty liver disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094609
Enrollment
Unknown
Registered
2024-12-25
Start date
2024-12-27
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic dysfunction-associated fatty liver disease (MAFLD)

Interventions

TRE group:Participants were provided approximately 30% of their energy requirements on fasting days (three non-consecutive days a week) and fast for 20 hours, and need to complete their eating from 8:
5:2 IF group:Participants were provided approximately 30% of their energy requirements on fasting days (two non-consecutive days a week), and they were allowed to eat and drink ad libitum on non-fasti
Control group:The participants were asked to maintain their weight throughout the trial and not to change their diet or physical activity habits, participants were given dietary guidance on metabolic-
Observation group:None

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Establish database for MAFLD Patients aged 18-55 years with a diagnosis of fatty liver by imaging or histology (liver ultrasound or CT or MRI), or obese (BMI>= 28kg/m2) with elevated aminotransferases (ALT>40U/L or AST>40U/L) are screened in the outpatient and the Department of Gastroenterology in our hospital. 2. Interventional study (1) Age 18-55 years old; (2) Diagnosis of fatty liver by imaging (liver ultrasound or CT or MRI) or liver histology (liver biopsy >=5% hepatic macrovesicular steatosis, MaS); (3) Elevated aminotransferases (ALT>40U/L) or presence of at least one of the following and metabolic syndrome components: a. Overweight/obesity, BMI >= 24kg/m2 or waist circumference >= 90cm (males) and 85cm (females), or body fat content and body fat percentage exceeding the standard; b. Hypertensive disease or increased arterial blood pressure, blood pressure >= 130/ 85mmHg or receiving antihypertensive medication; c. Prediabetes or type 2 diabetes mellitus, fasting blood glucose >= 6.1 mmol/L, or blood glucose >= 7.8 mmol/L or HbA1c >=5.7% 2 hours after glucose load, or history of type 2 diabetes mellitus; d. Elevated blood triglyceride (TG) with TG >= 1.7mmol/L or receiving hypolipidemic drugs; e Decreased blood high-density lipoprotein cholesterol (HDL-c), HDL-c 237dB/m;

Exclusion criteria

Exclusion criteria: 1. Establish database for MAFLD: None; 2. Partial exclusion criteria for Interventional study: (1) History of other causes of chronic liver disease such as acute or chronic viral hepatitis, drug-induced liver disease or autoimmune hepatitis, excessive alcohol consumption (female>= 140g ethanol/w; Male >=210 g ethanol/w), history of hepatic decompensation, Child-Pugh class B/ C; (2) Severe gastrointestinal disease or gastrointestinal surgery within the past 12 months, or weight loss of >= 10% or weight gain of >= 5% in the past 6 months, or a physical condition that prevents fasting, or the use of weight-loss medications or supplements that may interact with the effects of diet during the intervention period. (3) History of chronic kidney disease, severe cardio-cerebrovascular or pulmonary diseases, poor glycemic control or serious complications of diabetes, depression, cancer, autoimmune diseases; (4) Those who are unable to collect blood and fecal samples.

Design outcomes

Primary

MeasureTime frame
Change in liver fat content from baseline to 2 month intervention;

Secondary

MeasureTime frame
Severity of liver fibrosis;Changes in composition and function of gut microbiota;

Countries

China

Contacts

Public ContactTongyu Wang

China-Japan Friendship Hospital

wang_tongyu@sina.com+86 198 2183 9135

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026