Metabolic Adaptation to High-Intensity Interval TrainingRENACENCT07552727
Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis
A study testing High-intensity interval training in people with Metabolic Adaptation to High-Intensity Interval Training and Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), run by Universidad San Sebastián at 1 site in Chile.
Trial summary
This study proposes a single-blind randomized clinical trial designed to evaluate the effects of high-intensity interval training (HIIT) on liver health in adults with overweight or obesity, while also assessing the usefulness of FibroScan as a tool for detecting and monitoring hepatic changes. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Metabolic Adaptation to High-Intensity Interval Training, Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 13 Apr 2026to 28 Feb 2027
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 59 years from the Los Ríos Region
- Overweight or obesity (BMI >25 kg/m²)
- Diagnosis of a chronic noncommunicable disease such as insulin resistance, and type 2 diabetes
- Fit to perform physical activity/exercise
- Exercise readiness will be confirmed using the PAR-Q+ questionnaire
Who cannot join
- Excessive alcohol consumption
- Liver diseases of other etiologies
- Musculoskeletal and/or cardiovascular conditions that contraindicate exercise - Inability to attend in-person exercise sessions, or pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Centro de Estudios Cientificos
Valdivia, Los Ríos Region, 5090000
Felipe Barros, PhD, 56982108120, luis.barros@uss.cl
About this study
Official title: RENACE Study: Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis
This study proposes a single-blind randomized clinical trial designed to evaluate the effects of high-intensity interval training (HIIT) on liver health in adults with overweight or obesity, while also assessing the usefulness of FibroScan as a tool for detecting and monitoring hepatic changes. The study is grounded in the idea that HIIT may improve liver status in individuals with metabolic dysfunction-associated steatotic liver disease, even in the absence of major weight loss, and that FibroScan could serve not only as a diagnostic method but also as a follow-up instrument during conservative treatment.
The sample will include 30 adults from the Los Ríos Region, aged 18 to 59 years, with BMI >25 kg/m² and chronic noncommunicable conditions such as dyslipidemia, diabetes, or hypertension, provided they are fit for exercise. Participants will be randomly assigned to either an intervention group (HIIT, n=15) or a non-trained control group (n=15). Recruitment will be community-based, using posters and social media, and eligibility will be screened with the PAR-Q+ questionnaire. Individuals with excessive alcohol intake, liver disease of other etiologies, pregnancy, or contraindications to exercise will be excluded.
Read more
The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. The training will be supervised by a physical therapist experienced in cardiometabolic exercise prescription, and the control group will receive training after the study is completed for ethical reasons.
Before and after the intervention, participants will undergo a comprehensive evaluation including blood sampling, anthropometry, body composition, and physical fitness assessment. Blood markers will include transaminases, lipid profile, glucose, and HbA1c. Liver health will be assessed by FibroScan through controlled attenuation parameter (CAP) for steatosis and liver stiffness for fibrosis. Additional variables such as waist circumference, muscle mass, fat mass, handgrip strength, and prior physical activity level will also be recorded.
Statistically, the study will compare baseline differences between groups and evaluate pre-post changes after the intervention using parametric or nonparametric tests according to data distribution, along with correlation and multiple regression analyses. The expected outcome is that HIIT will improve liver-related parameters, and that FibroScan will be sensitive enough to detect these changes, supporting its value as a regional clinical tool for the identification and follow-up of hepatic steatosis and fibrosis in people with overweight or obesity.
- Conditions
- Metabolic Adaptation to High-Intensity Interval Training, Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
- Being tested
- High-intensity interval training
- Keywords
- Exercise, Liver, Obesity
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention. This group will receive a one-session councelling regarding the benefits of physical activity and nutrition in the management of fatty liver disease. |
| High-intensity interval training group | Experimental | The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. Receives: Behavioral: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
This will be measured through the calculation of the HOMA-IR before and after the study.
Measured: This will be measured at week 0 and week 8
Liver steatosis and fibrosis
This will be measured through FibroScan before and after the exercise
Measured: This will be measured at week 0 and week 8 of the study.
Secondary outcomes (1)
KLK7 and plasmatic kallikrein
These proteins will be measured before and after the study in plasma samples of the participants
Measured: This will be measured at week 0 and week 8 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start13 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Adaptation to High-Intensity Interval TrainingStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Sebastián
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Martinez-Huenchullan, Universidad San Sebastián
- Investigators
- Sergio Martínez Huenchullán, PhD, Principal investigator, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552727
- Sponsor's protocol ID
- 15/2026
- Acronym
- RENACE
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Considering that the investigators will collect personal information of each participant, for Ethical reasons, the investigators will share only group data, such as means and standard deviation.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENACE Study: Rehabilitation With Exercise-Based Intervention for Nonalcoholic Chronic Hepatic Esteatosis
- ClinicalTrials.gov ID
- NCT07552727
- Acronym / sponsor ID
- RENACE / 15/2026
- Conditions
- Metabolic Adaptation to High-Intensity Interval Training, Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)
- Keywords
- Exercise, Liver, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad San SebastiánUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Apr 2026 (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.
This study proposes a single-blind randomized clinical trial designed to evaluate the effects of high-intensity interval training (HIIT) on liver health in adults with overweight or obesity, while also assessing the usefulness of FibroScan as a tool for detecting and monitoring hepatic changes. The study is grounded in the idea that HIIT may improve liver status in individuals with metabolic dysfunction-associated steatotic liver disease, even in the absence of major weight loss, and that FibroScan could serve not only as a diagnostic method but also as a follow-up instrument during conservative treatment.
The sample will include 30 adults from the Los Ríos Region, aged 18 to 59 years, with BMI >25 kg/m² and chronic noncommunicable conditions such as dyslipidemia, diabetes, or hypertension, provided they are fit for exercise. Participants will be randomly assigned to either an intervention group (HIIT, n=15) or a non-trained control group (n=15). Recruitment will be community-based, using posters and social media, and eligibility will be screened with the PAR-Q+ questionnaire. Individuals with excessive alcohol intake, liver disease of other etiologies, pregnancy, or contraindications to exercise will be excluded.
The HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. The training will be supervised by a physical therapist experienced in cardiometabolic exercise prescription, and the control group will receive training after the study is completed for ethical reasons.
Before and after the intervention, participants will undergo a comprehensive evaluation including blood sampling, anthropometry, body composition, and physical fitness assessment. Blood markers will include transaminases, lipid profile, glucose, and HbA1c. Liver health will be assessed by FibroScan through controlled attenuation parameter (CAP) for steatosis and liver stiffness for fibrosis. Additional variables such as waist circumference, muscle mass, fat mass, handgrip strength, and prior physical activity level will also be recorded.
Statistically, the study will compare baseline differences between groups and evaluate pre-post changes after the intervention using parametric or nonparametric tests according to data distribution, along with correlation and multiple regression analyses. The expected outcome is that HIIT will improve liver-related parameters, and that FibroScan will be sensitive enough to detect these changes, supporting its value as a regional clinical tool for the identification and follow-up of hepatic steatosis and fibrosis in people with overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention. This group will receive a one-session councelling regarding the benefits of physical activity and nutrition in the management of fatty liver disease. |
| High-intensity interval training group | Experimental | Behavioral: High-intensity interval trainingThe HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 to 59 years from the Los Ríos Region
- Overweight or obesity (BMI >25 kg/m²)
- Diagnosis of a chronic noncommunicable disease such as insulin resistance, and type 2 diabetes
- Fit to perform physical activity/exercise
- Exercise readiness will be confirmed using the PAR-Q+ questionnaire
Key exclusion criteria (3 listed)
- Excessive alcohol consumption
- Liver diseases of other etiologies
- Musculoskeletal and/or cardiovascular conditions that contraindicate exercise - Inability to attend in-person exercise sessions, or pregnancy
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 |
|---|---|---|
| High-intensity interval trainingThe HIIT intervention will last 8 weeks, with 2 to 3 sessions per week, each session lasting 30 minutes. The protocol consists of five 2.5-minute bouts at 80% of heart rate reserve, interspersed with 2.5-minute active recovery periods at 20% of heart rate reserve. | Behavioural | High-intensity interval training group |
Primary outcome
Insulin resistance
Time frame: This will be measured at week 0 and week 8
This will be measured through the calculation of the HOMA-IR before and after the study.
Liver steatosis and fibrosis
Time frame: This will be measured at week 0 and week 8 of the study.
This will be measured through FibroScan before and after the exercise
1 secondary outcome
KLK7 and plasmatic kallikrein
Time frame: This will be measured at week 0 and week 8 of the study
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 5 May 2026.
- Individual participant dataSharing planned: No. Considering that the investigators will collect personal information of each participant, for Ethical reasons, the investigators will share only group data, such as means and standard deviation.
Related trials for Metabolic Adaptation to High-Intensity Interval Training
Recruiting
Redox Status and Exercise Training-induced Adaptations
Overweight (BMI > 25), Obesity
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.
Sergio Martínez Huenchullán, PhD principal investigator
Universidad San Sebastián
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with Metabolic Adaptation to High-Intensity Interval Training and Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD), run by Universidad San Sebastián at 1 site in Chile.
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 3 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Chile. 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 Sergio Martinez-Huenchullan, PhD (56962859896, sergio.martinez@uss.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: This will be measured at week 0 and week 8). The study lists 2 primary outcomes in all. 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 5 May 2026.