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Completed

NCT Number: NCT06338449

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.

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Key information

Age range

18 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outdoor track and field facility of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Aerobic training (AT)

Behavioral

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.

Resistance training (RT)

Behavioral

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.

Combined aerobic and resistance training (AT + RT)

Behavioral

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.

Primary outcomes

  1. Changes in body weight compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  2. Changes in Body Mass Index compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

    BMI

  3. Changes in total cholesterol compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  4. Changes in triglycerides compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  5. Changes in high-density lipoprotein compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  6. Changes in low-density lipoprotein compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  7. Changes in alanine aminotransferase compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  8. Changes in aspartate aminotransferase compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  9. Changes in alkaline phosphatase compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  10. Changes in gamma-glutamyl transferase compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  11. Changes in direct bilirubin compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  12. Changes in total bile acids compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  13. Changes in adenosine deaminase compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Changes in percentage of body fat compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  2. Changes in waist-to-hip ratio compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  3. Changes in blood glucose compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  4. Changes in the level of insulin compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  5. Changes in albumin compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

  6. Changes in C-reactive protein compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

Other outcomes

  1. Changes in other subtypes of bile acids compared to baseline at 8 weeks

    Time frame: Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Xuzhou Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2024
Registry last updated
Apr 2, 2024

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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