The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease

The purpose of this clinical trial is to investigate which exercise regimen is more effective in improving non-alcoholic fatty liver disease (NAFLD) in a young population. The primary questions it aims to answer are:

Does aerobic training, resistance training, or a combination of both help improve liver function and glycemic and lipid parameters in NAFLD patients? Which of these three exercise regimens is more effective in improving the aforementioned parameters? Is the improvement in liver function related to bile acid metabolism?

Participants will:

Engage in physical exercise 4-5 times per week for two consecutive months, following a predefined exercise regimen.

Have blood samples collected to test for glucose, lipids, liver function, and other parameters before starting the exercise program and after two months of completing the regimen.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease NAFLD
• Intervention / Treatment: Behavioral: Aerobic training (AT); Behavioral: Resistance training (RT); Behavioral: Combined aerobic and resistance training (AT + RT)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Outdoor track and field facility of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body fat percentage >20% or BMI >24
• The diagnostic result of abdominal ultrasonography is fatty liver
• No regular exercise under guidance in the past 3 months
• No medication taken in the last month
• No binge eating or heavy drinking in the past two weeks

Exclusion Criteria:

• Long history of alcohol consumption, equivalent to more than 30g/day of ethanol
• Viral hepatitis
• History of autoimmune or genetic diseases
• History of drug-induced liver disease
• History of total parenteral nutrition
• History of cardiovascular, respiratory, or other diseases that necessitate avoidance of intense physical activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aerobic training (AT); Aerobic exercise can include activities like swimming, running, or cycling. Scientifically, aerobic exercise is defined as any activity that uses large muscle groups, can be maintained continuously, and is rhythmic in nature. It improves the efficiency of the cardiovascular, respiratory, and circulatory systems by delivering oxygen more efficiently to the body. According to reports, aerobic exercise can help reduce fat and improve liver function.	Behavioral: Aerobic training (AT); An exercise program was developed by a full-time physical education teacher, with all group exercises conducted at the outdoor track and field facility of Xuzhou Medical University. Participants in the aerobic training group, after completing a warm-up, were required to perform moderate-intensity aerobic running for 60 minutes per session, 4-5 times a week. The exercise intensity was set to reach 50%-70% of the maximum heart rate (Maximum heart rate = 220 - age). The exercise sessions were scheduled in the evening after dinner, from 17:30 to 19:00.All participants were continuously intervened for 8 weeks.
Active Comparator: Resistance training (RT); Resistance exercise is a form of physical activity that is designed to improve muscular fitness by exercising a muscle or a muscle group against external resistance. This includes traditional weightlifting, using weight machines, resistance band exercises, bodyweight exercises, and other activities designed to build muscle strength, endurance, and size. The key principle is the muscle's ability to contract against resistance: using weights, resistance bands, or one's own body weight, the muscle is challenged, leading to muscular adaptation and growth, enhancing strength and endurance. According to reports, resistance exercise can also help improve liver function.	Behavioral: Resistance training (RT); Participants in the resistance training group were required to complete moderate-intensity resistance exercises 4-5 times per week. Each session included a warm-up, followed by exercises such as knee lifts with torso twists, knee-to-hand taps under the hips, jumping jacks, burpees, sit-ups, planks, and squats. The routine was structured to perform 5-6 exercises per session, with 6-8 repetitions for each set. There was a 30-second rest interval between sets, and the total exercise time was 60 minutes. The timing for these exercise sessions was the same as for the AT group, conducted in the evening after dinner.All participants were continuously intervened for 8 weeks.
Active Comparator: Combined aerobic and resistance training (AT + RT); The combination of aerobic exercise and resistance exercise.	Behavioral: Combined aerobic and resistance training (AT + RT); Participants in the combined aerobic and resistance training (AT+RT) group started their sessions with a warm-up, followed by 30 minutes of aerobic running. After the aerobic training, they engaged in resistance training. The resistance training regimen was the same as that for the RT group, except that the duration of the resistance training was shorter. The total duration of the exercise session was 60 minutes.All participants were continuously intervened for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in Body Mass Index compared to baseline at 8 weeks	BMI	Baseline and 8 weeks
Changes in total cholesterol compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in triglycerides compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in high-density lipoprotein compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in low-density lipoprotein compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in alanine aminotransferase compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in aspartate aminotransferase compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in alkaline phosphatase compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in gamma-glutamyl transferase compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in direct bilirubin compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in total bile acids compared to baseline at 8 weeks		Baseline and 8 weeks
Changes in adenosine deaminase compared to baseline at 8 weeks		Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in percentage of body fat compared to baseline at 8 weeks	Baseline and 8 weeks
Changes in waist-to-hip ratio compared to baseline at 8 weeks	Baseline and 8 weeks
Changes in blood glucose compared to baseline at 8 weeks	Baseline and 8 weeks
Changes in the level of insulin compared to baseline at 8 weeks	Baseline and 8 weeks
Changes in albumin compared to baseline at 8 weeks	Baseline and 8 weeks
Changes in C-reactive protein compared to baseline at 8 weeks	Baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Changes in other subtypes of bile acids compared to baseline at 8 weeks	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: aerobic exercise; resistance exercise; non-alcoholic fatty liver disease; bile acids; liver function
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: XZMU-2022-ZK068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The experimental data involves personal privacy and will only be publicly shared when necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No