Clinical trial NCT06338449: The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease
Official title: The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease NAFLD
Keywords: non-alcoholic fatty liver disease
aerobic exercise
resistance exercise
bile acids
liver function
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The specific exercise plan and grouping are as follows:

Participants were randomly (Using an electronic random number generator) divided into four groups: control group (Control), aerobic training group (AT), resistance training group (RT), and combined aerobic and resistance training group (AT + RT), with each group consisting of 10 individuals, totaling 40 participants. All participants were young adults aged between 18 and 21 years old.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in body weight compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in Body Mass Index compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in total cholesterol compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in triglycerides compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in high-density lipoprotein compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in low-density lipoprotein compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in alanine aminotransferase compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in aspartate aminotransferase compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in alkaline phosphatase compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in gamma-glutamyl transferase compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in direct bilirubin compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in total bile acids compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in adenosine deaminase compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Changes in percentage of body fat compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in waist-to-hip ratio compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in blood glucose compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in the level of insulin compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in albumin compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
measure: Changes in C-reactive protein compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Changes in other subtypes of bile acids compared to baseline at 8 weeks
timeFrame: Baseline and 8 weeks
Locations:
city: Xuzhou
country: China
facility: Outdoor track and field facility of Xuzhou Medical University
state: Jiangsu
Study officials:
References: