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Completed

NCT Number: NCT04795973

Effects of Intermittent Fasting on Fatty Liver Disease

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.

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Key information

Conditions

Sensitivity to Thyroid Hormones Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Parameters Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss in Patients With FLD

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chao-yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

5:2 intermittent fasting

Behavioral

All subjects received 5:2 IF. They followed a normal diet for 5 days each week and practiced IF for 2 days discontinuously. On normal eating days, women consumed 1200 to 1500 kcal/day and men consumed 1500 to 1800 kcal/day, with macro-nutrient distribution of 45% to 50% carbohydrate, 20% protein, and 30% to 35% fat. They consumed 500 kcal and at least 50 g of protein on a light fasting day. Noncaloric beverages like water and unsweetened tea were allowed without restriction. A nutritionist provided diet guidance and documented any discomfort symptoms throughout the study.

Primary outcomes

  1. Body Mass Index (BMI, kg/m²) measured using digital scale and stadiometer

    Time frame: 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.

  2. TSH Index (TSHI) calculated from serum TSH and FT4 levels

    Time frame: 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.

  3. Thyrotroph Thyroid Hormone Sensitivity Index (TTSI) calculated from serum TSH and FT4 levels

    Time frame: 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.

  4. FT3/FT4 ratio calculated from serum FT3 and FT4 levels

    Time frame: 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.

  5. Changes in metabolic parameters after 8-week IF intervention, measured using blood tests and biochemical assays.

    Time frame: 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.

  6. Changes in abdominal MRI findings (liver fat deposition) after 8-week IF intervention, assessed using magnetic resonance imaging

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2021
Registry last updated
Sep 22, 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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