Effects of Intermittent Fasting on Fatty Liver Disease

Capital Medical University

Status: Completed

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

Treatments: Behavioral: 5:2 intermittent fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04795973

2021-IF-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

5:2 intermittent fasting

Experimental group

Description:

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.

Treatment:

Behavioral: 5:2 intermittent fasting