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

April 1, 2024 updated by: Yang Qiang, Xuzhou Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in body weight compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in Body Mass Index compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
BMI
Baseline and 8 weeks
Changes in total cholesterol compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in triglycerides compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in high-density lipoprotein compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in low-density lipoprotein compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in alanine aminotransferase compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in aspartate aminotransferase compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in alkaline phosphatase compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in gamma-glutamyl transferase compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in direct bilirubin compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in total bile acids compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in adenosine deaminase compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in percentage of body fat compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in waist-to-hip ratio compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in blood glucose compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in the level of insulin compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in albumin compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Changes in C-reactive protein compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Changes in other subtypes of bile acids compared to baseline at 8 weeks
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-alcoholic Fatty Liver Disease NAFLD

Clinical Trials on Aerobic training (AT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings