Effects of Intermittent Fasting on Fatty Liver Disease

Not Applicable

Completed

• Conditions: Sensitivity to Thyroid Hormones; Metabolic Parameters; in Patients With FLD

• Registration Number: NCT04795973
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital. All of the following inclusion criteria needed to be met: hepatic fat content (HFC) were upper 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.

Detailed Description

Eighty subjects with FLD were recruited from the endocrinology clinic at Beijing Chao-yang Hospital, Capital Medical University, China, between September 22, 2020 and April 30, 2021. Inclusion criteria were hepatic fat content (HFC) \> 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations, age ≥ 18 years, body mass index (BMI) ≥ 18.5 kg/m2, and stable body weight (change \< ± 10% of body weight) during the last 3 months. Participants underwent an 8-week 5:2 IF intervention. Metabolic parameters and thyroid hormone sensitivity indices were assessed at baseline and after intervention.

Study Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• hepatic fat content (HFC) > 5.0% evaluated by upper abdominal MRI proton density fat fraction (MRI-PDFF) examinations
• age ≥ 18 years
• body mass index (BMI) ≥ 18.5 kg/m2
• stable body weight (change < ± 10% of body weight) during the last 3 months

Exclusion Criteria

• plasma aspartate aminotransferase (AST) and alanine amino-transferase (ALT) levels exceeded 2.5 times of the upper limit of normal
• fasting blood glucose (FBG) levels ≥ 7.0 mmol/L or glycated hemoglobin A1c (HbA1c) ≥ 6.5%
• with type 1 or type 2 diabetes
• with heart disease
• with other hepatic disease (excluding FLD)
• with renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer	8 weeks	BMI will be calculated as weight (kg) divided by height squared (m²). Weight will be measured on a calibrated digital scale and height using a stadiometer. Measurements will be taken at baseline and after the 8-week intermittent fasting intervention.
TSH Index (TSHI) calculated from serum TSH and FT4 levels	8 weeks	Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be determined using a standardized automated immunoassay. TSH Index will be calculated according to published formulas.
Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels	8 weeks	Fasting blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum TSH and FT4 concentrations will be measured using a standardized automated immunoassay. TTSI will be calculated according to published formulas.
FT3/FT4 ratio calculated from serum FT3 and FT4 levels	8 weeks	Fasting venous blood samples will be collected at baseline and after the 8-week intermittent fasting intervention. Serum FT3 and FT4 concentrations will be measured using a standardized automated immunoassay, and the FT3/FT4 ratio will be calculated as an index of peripheral thyroid hormone conversion efficiency.
Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays.	8 weeks	Lipid profile: Total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) will be measured from fasting blood samples.; Glycated hemoglobin (HbA1c, %) will be measured using high-performance liquid chromatography (HPLC). Fasting glucose (mg/dL or mmol/L) will be measured using an enzymatic glucose oxidase method. Fasting insulin (μIU/mL) will be measured using an electrochemiluminescence immunoassay. All blood samples will be collected after an overnight fast at baseline and after the 8-week IF intervention.
Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging	8 weeks	Abdominal fat distribution and liver fat content will be assessed using magnetic resonance imaging (MRI). Scans will be performed at baseline and after the 8-week IF intervention.

Trial Locations

Locations (1)

Beijing Chao-yang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing Municipality, China