Metabolic Dysfunction-Associated Fatty Liver DiseaseCEPHITNCT07177963
CPET-based HIIT for MAFLD
A study testing HIIT and No specific exercise intervention. in people with Metabolic Dysfunction-Associated Fatty Liver Disease, run by Tang Yida at 5 sites in China.
Trial summary
High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Fatty Liver Disease
- What is being tested?
- HIIT and No specific exercise intervention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesChina
- Study dates
- 8 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 35~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography
- In conjunction with at least one cardiometabolic risk factor:
- Overweight or Obesity: ≥ 24kg/m2，or waist circumference ≥ 90 cm in men and > 85 cm in women, or excessive body fat mass
- Prediabetes or type 2 diabetes mellitus: HbA1c ≥ 5.7%, or fasting plasma glucose ≥ 6.1mmol/L, or 2-h plasma glucose during OGTT ≥ 7.8mmol/L
- Plasma triglycerides ≥ 1.7 mmol/L (>-150 mg/dl) or lipid-lowering treatment
- HDL-cholesterol ≤ -1.0 mmol/L in men and ≤ -1.3 mmol/L in women or lipid-lowering treatment
- Blood pressure ≥ 130/85 mmHg or treatment for hypertension
Who cannot join
- Contraindications for Cardiopulmonary Exercise Testing
- The electrocardiogram (ECG) results during cardiopulmonary exercise testing (CPET) showed positive findings
- Receiving GLP-1 receptor agonists, SGLT-2i, or taking >2 antihypertensive/hypoglycemic/lipid-lowering/ antiarrhythmic drugs
- Taking dietary supplements (e.g., fish oil products, over-the-counter diet pills, meal replacements)
- Mental illness
- Other liver diseases
- Movement disorder related diseases and lower limb motor injury in the past 6 months
- Pregnant, lactating or planning to become pregnant in the near future
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Beijing Ditan Hospital, Capital Medical University
Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing
Beijing Youan Hospital, Capital Medical University
Beijing
Peking University Third Hospital
Beijing
The Fifth Medical Center, Chinese PLA General Hospital
Beijing
About this study
Official title: Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving MAFLD
High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols.
Based on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.
Read the detailed description
54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session comprises 8 cycles with 30-second bouts at 80% peak VO₂ followed by 60-second recoveries at 50% peak VO₂. The control group do not take any types of exercise interventions. Standard care would be provided for both groups.
- Being tested
- HIIT, No specific exercise intervention.
- Keywords
- CPET, Exercise, HITT, Peak VO2, MAFLD
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
Exercise sessions were conducted as telemedically supervised, home-based HIIT performed on electric resistance bikes, with protocols individually tailored. Each HIIT session comprised 8 cycles of alternating 30-second high-intensity intervals (HIT at 80% peakVO₂) and 60-second low-intensity recovery intervals (LIT at 50% peakVO₂). Warm-up and cool-down phases were performed with the bike's resistance set to 0 watts (unloaded pedaling). The total intervention duration was 8 weeks. Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period.
No specific exercise intervention.Behavioural
The control group will not receive any exercise intervention, and they will be instructed to not take any structured exercise regimens.Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| HIIT group | Experimental | Home-based HIIT performed on electric resistance bikes. Receives: Behavioral: HIIT |
| Control Group | Other | No specific exercise intervention. Receives: Behavioral: No specific exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content (%)
Liver fat content will be measured using MRI-PDFF.
Measured: Baseline (week 0) , after complete post-training (week 8).
Secondary outcomes (17)
LSM (kPa)
Liver fibrosis will be measured using MRE.
Measured: Baseline (week 0) , after complete post-training (week 8).
Blood specimen
Lab tests include red blood cell count.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include hematocrit.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include hemoglobin count.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include testosterone.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include cortisol.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include creatine kinase.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include blood urea.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include alanine aminotransferase.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include aspartate aminotransferase.
Measured: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Lab tests include lactic acid
Measured: After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).
Exercise Feasibility
The implementation status of the home-based exercise prescription, including training frequency per week, average pedal frequency of the high-intensity exercise on the resistance bike, and average pedal frequency of the low-intensity exercise on the resistance bike
Measured: Every week after complete training from week 1 to week 8.
LSM (kPa)
Liver fibrosis will be measured using Fibrotouch@.
Measured: Baseline (week 0) , after complete post-training (week 8).
Peak VO2
Peak VO2 is assessed through CPET, using a maximal graded treadmill test based on the Chinese expert consensus on the standardized clinical application of CPET.
Measured: Baseline (week 0) , after complete post-training (week 8).
BMI
Weight (kg) is measured with digital weighing scale. Height (cm) is measured with a portable stadiometer. BMI is calculated as weight in kilograms divided by the square of height in meters
Measured: Baseline (week 0) , after complete post-training (week 8).
Brog score
The Borg Subjective Fatigue Scale (Borg) would be tested after each session
Measured: After complete mid-training (week 4) , after complete post-training (week 8).
Exercise Feasibility
The proportion of subjects leaving group during the preparation period and early termination of the trial
Measured: From baseline (week 0) to after complete post-training (week 8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start8 Sep 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Fatty Liver DiseaseStudies 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
- 54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session comprises 8 cycles with 30-second bouts at 80% peak VO₂ followed by 60-second recoveries at 50% peak VO₂. The control group do not take any types of exercise interventions. Standard care would be provided for both groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang Yida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tang Yida, Peking University Third Hospital
- Investigators
- Yida Tang, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177963
- Sponsor's protocol ID
- CPHIT1
- Acronym
- CEPHIT
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving MAFLD
- ClinicalTrials.gov ID
- NCT07177963
- Acronym / sponsor ID
- CEPHIT / CPHIT1
- Keywords
- CPET, Exercise, HITT, Peak VO2, MAFLD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Tang YidaUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
High-intensity interval training (HIIT), as an individualized exercise training mode based on cardiopulmonary exercise testing (CPET), is characterized by high-intensity training sessions interspersed with short rest periods. The findings from recent trials suggest that in the management of metabolic dysfunction-associated fatty liver disease (MAFLD), compared with traditional aerobic exercise modes such as moderate-intensity continuous training, HIIT may achieve similar or even better effects in reducing liver fat content, increasing peak oxygen uptake, improving insulin resistance, and lowering blood pressure, despite requiring less time commitment and lower energy expenditure. However, there is currently no consensus regarding the formulation of HIIT exercise protocols.
Based on the lower limits of the current mainstream HIIT intensity, sets, and interval time parameters, this study aims to assess the effectiveness, safety, and feasibility of the current exercise prescription in improving MAFLD.
Detailed description
54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session comprises 8 cycles with 30-second bouts at 80% peak VO₂ followed by 60-second recoveries at 50% peak VO₂. The control group do not take any types of exercise interventions. Standard care would be provided for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 54 Participants aged 35-65 years with MAFLD will be randomized 1:1 to intervention or control. The intervention group will undertake home-based HIIT four times weekly for 8 weeks. Each session comprises 8 cycles with 30-second bouts at 80% peak VO₂ followed by 60-second recoveries at 50% peak VO₂. The control group do not take any types of exercise interventions. Standard care would be provided for both groups.
| Arm | Type | Receives |
|---|---|---|
| HIIT group | Experimental | Behavioral: HIITHome-based HIIT performed on electric resistance bikes. |
| Control Group | Other | Behavioral: No specific exercise intervention.No specific exercise intervention. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults age 35~65 years Nonalcoholic fatty liver diagnosed by abdominal ultrasonography
- Overweight or Obesity: ≥ 24kg/m2，or waist circumference ≥ 90 cm in men and > 85 cm in women, or excessive body fat mass
- Prediabetes or type 2 diabetes mellitus: HbA1c ≥ 5.7%, or fasting plasma glucose ≥ 6.1mmol/L, or 2-h plasma glucose during OGTT ≥ 7.8mmol/L
- Plasma triglycerides ≥ 1.7 mmol/L (>-150 mg/dl) or lipid-lowering treatment
- HDL-cholesterol ≤ -1.0 mmol/L in men and ≤ -1.3 mmol/L in women or lipid-lowering treatment
Key exclusion criteria (8 listed)
- Contraindications for Cardiopulmonary Exercise Testing
- The electrocardiogram (ECG) results during cardiopulmonary exercise testing (CPET) showed positive findings
- Receiving GLP-1 receptor agonists, SGLT-2i, or taking >2 antihypertensive/hypoglycemic/lipid-lowering/ antiarrhythmic drugs
- Taking dietary supplements (e.g., fish oil products, over-the-counter diet pills, meal replacements)
- Mental illness
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 |
|---|---|---|
| HIITExercise sessions were conducted as telemedically supervised, home-based HIIT performed on electric resistance bikes, with protocols individually tailored. Each HIIT session comprised 8 cycles of alternating 30-second high-intensity intervals (HIT at 80% peakVO₂) and 60-second low-intensity recovery intervals (LIT at 50% peakVO₂). Warm-up and cool-down phases were performed with the bike's resistance set to 0 watts (unloaded pedaling). The total intervention duration was 8 weeks. Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period. | Behavioural | HIIT group |
| No specific exercise intervention.The control group will not receive any exercise intervention, and they will be instructed to not take any structured exercise regimens.Received health lifestyle education based on the Prevention and Treatment Guidelines for Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition) and the Dietary Guidelines for Adults with Hyperlipidemia (2023 Edition).Wear smart bracelets 24/7 to monitor daily activity levels, with participants prohibited from engaging in any other systematic exercise training during the intervention period. | Behavioural | Control Group |
Primary outcome
Liver fat content (%)
Time frame: Baseline (week 0) , after complete post-training (week 8).
Liver fat content will be measured using MRI-PDFF.
17 secondary outcomes
LSM (kPa)
Time frame: Baseline (week 0) , after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: Baseline (week 0) , after complete mid-training (week 4), after complete post-training (week 8).
Blood specimen
Time frame: After first time and complete of mid-training (week 4), after first time and complete of post-training (week 8).
Exercise Feasibility
Time frame: Every week after complete training from week 1 to week 8.
LSM (kPa)
Time frame: Baseline (week 0) , after complete post-training (week 8).
Peak VO2
Time frame: Baseline (week 0) , after complete post-training (week 8).
BMI
Time frame: Baseline (week 0) , after complete post-training (week 8).
Brog score
Time frame: After complete mid-training (week 4) , after complete post-training (week 8).
Exercise Feasibility
Time frame: From baseline (week 0) to after complete post-training (week 8).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Yida Tang study chair
Peking University Third Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT and No specific exercise intervention. in people with Metabolic Dysfunction-Associated Fatty Liver Disease, run by Tang Yida at 5 sites 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yida Tang, MD,PhD (010-82265996, tangyida@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content (%) (time frame: Baseline (week 0) , after complete post-training (week 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.