Non-alcoholic Fatty LiverNCT07697313
High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
A study testing High intensity interval training, moderate intensity continuous training and Mediterranean diet in people with Non-alcoholic Fatty Liver, run by Horus University at 1 site in Egypt.
Trial summary
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Non-alcoholic Fatty Liver
- What is being tested?
- High intensity interval training, moderate intensity continuous training and Mediterranean diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2026to 10 Oct 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
- Body mass index will range from 30 to 34.9 kg/m².
- Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
- Patients who have taken no regular exercise in the last year (<3 times/week and 30 min/time.
- No antibiotic or probiotic use for at least last 3 months.
- Medical drugs such as metformin, sulfonylureas, statins, and blood pressure medication were eligible, as well as stable.
Who cannot join
- History of liver cirrhosis or other chronic liver diseases.
- Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
- Recent gastrointestinal infections or surgeries.
- Diabetes Mellitus type 1 or uncontrolled type 2.
- Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
- Active smokers.
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- Pregnancy or breastfeeding.
- Uncontrolled hypertension.
- Communication disorders.
- Bleeding disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
out-patient clinic, faculty of physical therapy, Horus university
Cairo
Heba Yasser Bihery, Assistant lecturer, 01065015529, hyasser@horus.edu.eg
About this study
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
Read the detailed description
non- Alcoholic Fatty Liver disease affects approximately 25% of the global population, with its prevalence increasing due to lifestyle changes such as poor diet and sedentary behavior. non- Alcoholic Fatty Liver disease is often associated with metabolic disorders, including insulin resistance, obesity, and type 2 diabetes. Emerging evidence suggests that alterations in gut microbiota may contribute to the pathophysiology of non- Alcoholic Fatty Liver disease, influencing liver function, inflammation, and metabolic regulation. However, there is limited research exploring the effects of interventions such as exercise and dietary changes on gut microbiota composition in non- Alcoholic Fatty Liver disease patients The findings of this study could have important clinical implications, particularly for developing tailored lifestyle interventions for non- Alcoholic Fatty Liver disease patients. As gut microbiota dysbiosis is increasingly recognized as a key player in the development and progression of non- Alcoholic Fatty Liver disease, interventions targeting microbiota balance could offer novel therapeutic approaches for managing this prevalent and potentially severe condition
- Conditions
- Non-alcoholic Fatty Liver
- Being tested
- High intensity interval training, moderate intensity continuous training, Mediterranean diet
- 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.
High intensity interval trainingOther
Patients will engage in high-intensity interval training using heart rate reserve (HRR) to determine exercise intensity. The program includes three sessions per week for 12 weeks, featuring three 3-minute high-intensity intervals at 70-90% HRR, with 2 minutes of active recovery in between. Each 30-minute session will be treadmill-based under supervision, incorporating warm-up and cool-down periods. Participants will also follow a Mediterranean diet.
moderate intensity continuous trainingOther
The program will be in form of:
- Frequency: 3 sessions/week for 12 weeks.
- Intensity: Moderate intensity continues training at 40- 60% HRR.
- Duration: the session will last 30 minutes per session. Patients will be instructed to follow Mediterranean Diet.
Mediterranean dietOther
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
| Study group | Role | What they receive |
|---|---|---|
| high intensity interval training and Mediterranean diet | Experimental | This study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet. Receives: Other: High intensity interval training; Other: Mediterranean diet |
| moderate intensity continous training and Mediterranean diet | Experimental | This group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet. Receives: Other: moderate intensity continuous training; Other: Mediterranean diet |
| Mediterranean Diet | Active comparator | It is characterized by a high consumption of plant-based foods, such as vegetables, fruits, whole grains, seeds, nuts and legumes, and moderate consumption of protein-source foods such as fish and poultry. This diet is rich in monounsaturated fatty acids primarily from olive oil and olives, reduced fat dairy products and low red meat intake. Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of short chain free fatty acids butyrate and acetate
For short chain free fatty acids analyses, fecal sample will be separated. Applying four analytes, including total Short Chain Fatty Acids, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids from fecal samples
Measured: at baseline and after 12 weeks
assessment of lipid profile
Fasting blood samples were collected after an overnight fast, and serum lipid levels were analyzed using standard enzymatic methods with an automated biochemical analyzer. The lipid profile included triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol to assess lipid metabolism and cardiovascular risk.
Measured: at baseline and after 12 weeks
Secondary outcomes (1)
assessment of quality of life
The short form-12 was scored using the standard scoring algorithm, which converts participants' responses into two norm-based summary measures: the Physical Component Summary and the Mental Component Summary. Each score ranges from 0 to 100, with higher scores indicating better health-related quality of life. The scores were calculated according to the official short form -12 scoring guidelines.
Measured: at baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty LiverStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Yasser, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697313
- Sponsor's protocol ID
- Heba-Phd
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
- ClinicalTrials.gov ID
- NCT07697313
- Acronym / sponsor ID
- Heba-Phd
- Conditions
- Non-alcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 13 Jul 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.
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
Detailed description
non- Alcoholic Fatty Liver disease affects approximately 25% of the global population, with its prevalence increasing due to lifestyle changes such as poor diet and sedentary behavior. non- Alcoholic Fatty Liver disease is often associated with metabolic disorders, including insulin resistance, obesity, and type 2 diabetes. Emerging evidence suggests that alterations in gut microbiota may contribute to the pathophysiology of non- Alcoholic Fatty Liver disease, influencing liver function, inflammation, and metabolic regulation. However, there is limited research exploring the effects of interventions such as exercise and dietary changes on gut microbiota composition in non- Alcoholic Fatty Liver disease patients The findings of this study could have important clinical implications, particularly for developing tailored lifestyle interventions for non- Alcoholic Fatty Liver disease patients. As gut microbiota dysbiosis is increasingly recognized as a key player in the development and progression of non- Alcoholic Fatty Liver disease, interventions targeting microbiota balance could offer novel therapeutic approaches for managing this prevalent and potentially severe condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high intensity interval training and Mediterranean diet | Experimental | Other: High intensity interval training, Other: Mediterranean dietThis study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet. |
| moderate intensity continous training and Mediterranean diet | Experimental | Other: moderate intensity continuous training, Other: Mediterranean dietThis group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet. |
| Mediterranean Diet | Active comparator | Other: Mediterranean dietIt is characterized by a high consumption of plant-based foods, such as vegetables, fruits, whole grains, seeds, nuts and legumes, and moderate consumption of protein-source foods such as fish and poultry. This diet is rich in monounsaturated fatty acids primarily from olive oil and olives, reduced fat dairy products and low red meat intake. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
- Body mass index will range from 30 to 34.9 kg/m².
- Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
- Patients who have taken no regular exercise in the last year (<3 times/week and 30 min/time.
- No antibiotic or probiotic use for at least last 3 months.
Key exclusion criteria (10 listed)
- History of liver cirrhosis or other chronic liver diseases.
- Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
- Recent gastrointestinal infections or surgeries.
- Diabetes Mellitus type 1 or uncontrolled type 2.
- Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
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 trainingPatients will engage in high-intensity interval training using heart rate reserve (HRR) to determine exercise intensity. The program includes three sessions per week for 12 weeks, featuring three 3-minute high-intensity intervals at 70-90% HRR, with 2 minutes of active recovery in between. Each 30-minute session will be treadmill-based under supervision, incorporating warm-up and cool-down periods. Participants will also follow a Mediterranean diet. | Other | high intensity interval training and Mediterranean diet |
| moderate intensity continuous trainingThe program will be in form of: * Frequency: 3 sessions/week for 12 weeks. * Intensity: Moderate intensity continues training at 40- 60% HRR. * Duration: the session will last 30 minutes per session. Patients will be instructed to follow Mediterranean Diet. | Other | moderate intensity continous training and Mediterranean diet |
| Mediterranean dietthe composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods. | Other | Mediterranean Diet, high intensity interval training and Mediterranean diet, moderate intensity continous training and Mediterranean diet |
Primary outcome
assessment of short chain free fatty acids butyrate and acetate
Time frame: at baseline and after 12 weeks
For short chain free fatty acids analyses, fecal sample will be separated. Applying four analytes, including total Short Chain Fatty Acids, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids from fecal samples
assessment of lipid profile
Time frame: at baseline and after 12 weeks
Fasting blood samples were collected after an overnight fast, and serum lipid levels were analyzed using standard enzymatic methods with an automated biochemical analyzer. The lipid profile included triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol to assess lipid metabolism and cardiovascular risk.
1 secondary outcome
assessment of quality of life
Time frame: at baseline and after 12 weeks
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 13 Jul 2026.
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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.
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, moderate intensity continuous training and Mediterranean diet in people with Non-alcoholic Fatty Liver, run by Horus University at 1 site in Egypt.
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 6 inclusion and 10 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 13 Jul 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 Egypt. 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 Heba Yasser Bihery, Assistant lecturer (01065015529, hyasser@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of short chain free fatty acids butyrate and acetate (time frame: at baseline and after 12 weeks). 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 13 Jul 2026.