Non-alcoholic Fatty Liver Disease NAFLDNCT06338449
The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease
A study testing Aerobic training (AT), Resistance training (RT) and Combined aerobic and resistance training (AT + RT) in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Xuzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 23 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease NAFLD
- What is being tested?
- Aerobic training (AT), Resistance training (RT) and Combined aerobic and resistance training (AT + RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Outdoor track and field facility of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
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?
Read more
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.
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Being tested
- Aerobic training (AT), Resistance training (RT), Combined aerobic and resistance training (AT + RT)
- Keywords
- non-alcoholic fatty liver disease, aerobic exercise, resistance exercise, bile acids, liver function
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training (AT)Behavioural
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)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training (AT) | Active comparator | 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. Receives: Behavioral: Aerobic training (AT) |
| Resistance training (RT) | Active comparator | 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. Receives: Behavioral: Resistance training (RT) |
| Combined aerobic and resistance training (AT + RT) | Active comparator | The combination of aerobic exercise and resistance exercise. Receives: Behavioral: Combined aerobic and resistance training (AT + RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in Body Mass Index compared to baseline at 8 weeks
BMI
Measured: Baseline and 8 weeks
Changes in total cholesterol compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in triglycerides compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in high-density lipoprotein compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in low-density lipoprotein compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in alanine aminotransferase compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in aspartate aminotransferase compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in alkaline phosphatase compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in gamma-glutamyl transferase compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in direct bilirubin compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in total bile acids compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in adenosine deaminase compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Changes in percentage of body fat compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in waist-to-hip ratio compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in blood glucose compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in the level of insulin compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in albumin compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Changes in C-reactive protein compared to baseline at 8 weeks
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start13 Oct 2022
- Primary completion20 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver Disease NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Qiang, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338449
- Sponsor's protocol ID
- XZMU-2022-ZK068
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The experimental data involves personal privacy and will only be publicly shared when necessary.
Publications
Shi J, Cui J, Zheng T, Han X, Wang B, Wang W, Zhu C, Fang C, Zhou X, Cong N, Yin X, Yang Q. Comparative effects of aerobic and resistance exercise on bile acid profiles and liver function in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2025 Apr 10;25(1):239. doi: 10.1186/s12876-025-03826-x.
PubMed 40211236
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Exercise Modes on Bile Acid Levels and Liver Function in Patients With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06338449
- Acronym / sponsor ID
- XZMU-2022-ZK068
- Conditions
- Non-alcoholic Fatty Liver Disease NAFLD
- Keywords
- non-alcoholic fatty liver disease, aerobic exercise, resistance exercise, bile acids, liver function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic training (AT) | Active comparator | Behavioral: 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. |
| Resistance training (RT) | Active comparator | Behavioral: 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. |
| Combined aerobic and resistance training (AT + RT) | Active comparator | Behavioral: Combined aerobic and resistance training (AT + RT)The combination of aerobic exercise and resistance exercise. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Aerobic training (AT) |
| 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. | Behavioural | Resistance training (RT) |
| 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. | Behavioural | Combined aerobic and resistance training (AT + RT) |
Primary outcome
Changes in body weight compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in Body Mass Index compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
BMI
Changes in total cholesterol compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in triglycerides compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in high-density lipoprotein compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in low-density lipoprotein compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in alanine aminotransferase compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in aspartate aminotransferase compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in alkaline phosphatase compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in gamma-glutamyl transferase compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in direct bilirubin compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in total bile acids compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in adenosine deaminase compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
6 secondary outcomes
Changes in percentage of body fat compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in waist-to-hip ratio compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in blood glucose compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in the level of insulin compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in albumin compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Changes in C-reactive protein compared to baseline at 8 weeks
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 40211236Shi J, Cui J, Zheng T, Han X, Wang B, Wang W, Zhu C, Fang C, Zhou X, Cong N, Yin X, Yang Q. Comparative effects of aerobic and resistance exercise on bile acid profiles and liver function in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2025 Apr 10;25(1):239. doi: 10.1186/s12876-025-03826-x.
- Individual participant dataSharing planned: Undecided. The experimental data involves personal privacy and will only be publicly shared when necessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training (AT), Resistance training (RT) and Combined aerobic and resistance training (AT + RT) in people with Non-alcoholic Fatty Liver Disease NAFLD, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight compared to baseline at 8 weeks (time frame: Baseline and 8 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06338449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.