Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)NCT07480811
The Effect of the DASH Diet on Clinical and Metabolic Parameters in Children With MASLD
A study testing DASH Diet, Standart Diet and Physical Activity in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by Antalya Training and Research Hospital.
Trial summary
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in childhood is becoming increasingly prevalent, paralleling the rise in obesity rates, and has become the most common chronic liver disease in the pediatric population. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- What is being tested?
- DASH Diet, Standart Diet and Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2026to 30 Dec 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Eligibility criteria include being between 11 and 18 years of age,
- Having a body mass index (BMI) ≥95th percentile,
- Having hepatic steatosis detected by magnetic resonance imaging (MRI) and proton density fat fraction (PDFF) measurement (cutoff value ≥5%).
Who cannot join
- Other liver diseases (such as viral hepatitis, autoimmune hepatitis, Wilson's disease),
- Alcohol consumption,
- History of type I or type II diabetes,
- Use of medications that may affect fatty liver or blood lipid profile (corticosteroids, metformin, vitamin E, omega-3 fatty acids, etc.),
- Having participated in a weight loss program or undergone bariatric surgery prior to the study,
- Presence of chronic inflammatory disease, thyroid dysfunction (hyperthyroidism and hypothyroidism),
- Having received antibiotic treatment and used nutritional supplements in the last 3 months prior to the study,
- Having a psychiatric disorder that may affect adherence to the diet or the safety of exercise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in childhood is becoming increasingly prevalent, paralleling the rise in obesity rates, and has become the most common chronic liver disease in the pediatric population. MASLD is associated with metabolic mechanisms such as insulin resistance, dyslipidemia, oxidative stress, and inflammation, and can progress to serious complications like steatohepatitis, fibrosis, and cirrhosis in later stages. Currently, pharmacological treatments for managing MASLD are limited, and lifestyle modifications, particularly dietary interventions, stand out as the primary approach for preventing and treating the disease. In this context, the composition of macro and micronutrients plays a critical role in the development and progression of hepatic steatosis.
Within this framework, the Dietary Approaches to Stop Hypertension (DASH) diet is a balanced eating pattern that encourages the consumption of vegetables, fruits, whole grains, legumes, low-fat dairy products, fish, poultry, and healthy fat sources, while limiting sodium, saturated fat, sugary foods, and processed meat products. Similar to the Mediterranean diet, the DASH diet is a promising approach for conditions like metabolic syndrome and MASLD due to its anti-inflammatory potential, its reducing effect on oxidative stress, and its properties that enhance insulin sensitivity. Furthermore, thanks to its high fiber content, it contributes to balancing the gut microbiota and supports the production of short-chain fatty acids (SCFAs), which in turn have positive effects on liver and metabolic health.
Read more
Evaluated in terms of fat intake, the DASH diet's emphasis on foods rich in n-3 fatty acids (such as fish and walnuts) provides an anti-inflammatory effect, while limiting saturated and trans fats offers an important strategy for reducing hepatic fat accumulation. Additionally, restricting the consumption of added sugars and fructose may be effective in preventing hepatic steatosis by suppressing lipogenesis processes.
In light of all these scientific findings, considering the impact of dietary patterns on the development and progression of MASLD, appropriately structuring the diet is critically important for protecting liver health in children. Accordingly, an anti-inflammatory, antioxidant, and metabolically balanced DASH dietary model is considered an effective and applicable approach in the management of pediatric MASLD.
Within the scope of this study, the effects of implementing the DASH diet in children with MASLD on clinical and metabolic parameters such as liver enzymes, degree of hepatic steatosis, insulin resistance, lipid profile, and inflammatory markers will be evaluated compared to a control group. Additionally, by examining the relationships between these parameters and quality of life as well as dietary adherence, the potential therapeutic role of the DASH diet in the management of pediatric MASLD will be elucidated.
- Being tested
- DASH Diet, Standart Diet, Physical Activity
- Keywords
- MASLD, Diet modification, DASH Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH DietOther
The DASH diet is structured with a macronutrient distribution of 50-55% carbohydrates, 16-18% protein, and 27-30% fat. The diet plan recommends high intake of fruits, vegetables, low-fat dairy products, oilseeds, legumes, and whole grains, as well as low intake of sodium, sugary foods, and red and processed meats.
Standart DietOther
The standard diet is planned so that 45-60% of energy comes from carbohydrates, 25-35% from fats, and 15-20% from proteins. The standard diet is based on the healthy eating recommendations for children in the 2022 Turkish Nutrition Guide (TÜBER). Unlike the DASH diet, the standard diet allows the consumption of refined grains, full-fat milk and meat products, and simple sugars not exceeding 10% of energy.
Physical ActivityOther
The home-based exercise program aims to increase physical activity. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with parental guidance. Participants will be instructed to begin their workout with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step aerobics, dancing, throwing a ball against a wall, running up and down stairs), and conclude with 5 minutes of cool-down exercises (stretching).
| Study group | Role | What they receive |
|---|---|---|
| DASH Diet + Physical Activity | Active comparator | DASH Diet + Physical Activity The DASH diet is structured with a macronutrient distribution of 50-55% carbohydrates, 16-18% protein, and 27-30% fat. The diet plan includes high amounts of fruits, vegetables, low-fat dairy products, oilseeds, legumes, and whole grains, as well as low amounts of sodium, sugary foods, and red and processed meats. The goal is to increase physical activity with a home-based exercise program. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with a parent. Participants will be instructed to start the exercise with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step, dance, throwing a ball against a wall, running up and down stairs), and finish the exercise with 5 minutes of cool-down exercises (stretching). Receives: Other: DASH Diet; Other: Physical Activity |
| Standard Diet + Physical Activity | Experimental | Standard Diet + Physical Activity The standard diet is planned so that 45-60% of energy comes from carbohydrates, 25-35% from fats, and 15-20% from proteins. The standard diet is based on the healthy eating recommendations for children in the Turkish Nutrition Guide (TÜBER) 2022 Nutrition Guide. Unlike the DASH diet, the standard diet allows the consumption of refined grains, full-fat milk and meat products, and simple sugars not exceeding 10% of energy. The goal is to increase physical activity with a home-based exercise program. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with parental guidance. Participants will be instructed to begin their workout with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step aerobics, dancing, throwing a ball against a wall, running up and down stairs), and conclude with 5 minutes of cool Receives: Other: Standart Diet; Other: Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic steatosis percentage
Comparison of the change in hepatic steatosis percentage, as measured by MRI-PDFF, in diet groups over 12 weeks.
Measured: 12 weeks
Secondary outcomes (3)
Changes in insulin resistance
The insulin resistance index will be calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) formula.
Measured: 12 weeks
Changes in anthropometric measurements
Participants will wear light clothing, and their body weight (BW) will be recorded to the nearest 100g using a Seca scale. Height measurements will be taken with participants standing barefoot against a wall, ensuring proper alignment of the head, shoulders, pelvis, and heels. Weight will be measured in kilograms, and height in meters, and weight and height will be combined to report Body Mass Index (BMI) in kg/m². BMI will be calculated by dividing BW (kg) by the square of their height (m²) (kg/m²).
Measured: 12 weeks
Changes in fibrosis index
Changes in the Pediatric Non-alcoholic fatty liver disease Fibrosis Index (PNFI) score will be evaluated. The PNFI is a scale ranging from 0 to 10, with higher scores indicating a worse outcome (i.e., more severe liver fibrosis). This index is calculated based on age, waist circumference, and triglyceride levels, as developed and validated by Nobili et al. (2009).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start5 Apr 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 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 Steatotic Liver Disease (MASLD)Studies 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 study was designed as a randomized, parallel-assigned dietary intervention without blinding (open-label) because blinding the diets was impractical.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480811
- Sponsor's protocol ID
- Antalya Training and Research
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will present de-identified individual participant data collected during the trial, including demographic, anthropometric, dietary, and physical activity data, the study protocol, the statistical analysis plan, and the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the DASH Diet on Clinical and Metabolic Parameters in Children With MASLD
- ClinicalTrials.gov ID
- NCT07480811
- Acronym / sponsor ID
- Antalya Training and Research
- Keywords
- MASLD, Diet modification, DASH Diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 5 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Mar 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.
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) in childhood is becoming increasingly prevalent, paralleling the rise in obesity rates, and has become the most common chronic liver disease in the pediatric population. MASLD is associated with metabolic mechanisms such as insulin resistance, dyslipidemia, oxidative stress, and inflammation, and can progress to serious complications like steatohepatitis, fibrosis, and cirrhosis in later stages. Currently, pharmacological treatments for managing MASLD are limited, and lifestyle modifications, particularly dietary interventions, stand out as the primary approach for preventing and treating the disease. In this context, the composition of macro and micronutrients plays a critical role in the development and progression of hepatic steatosis.
Within this framework, the Dietary Approaches to Stop Hypertension (DASH) diet is a balanced eating pattern that encourages the consumption of vegetables, fruits, whole grains, legumes, low-fat dairy products, fish, poultry, and healthy fat sources, while limiting sodium, saturated fat, sugary foods, and processed meat products. Similar to the Mediterranean diet, the DASH diet is a promising approach for conditions like metabolic syndrome and MASLD due to its anti-inflammatory potential, its reducing effect on oxidative stress, and its properties that enhance insulin sensitivity. Furthermore, thanks to its high fiber content, it contributes to balancing the gut microbiota and supports the production of short-chain fatty acids (SCFAs), which in turn have positive effects on liver and metabolic health.
Evaluated in terms of fat intake, the DASH diet's emphasis on foods rich in n-3 fatty acids (such as fish and walnuts) provides an anti-inflammatory effect, while limiting saturated and trans fats offers an important strategy for reducing hepatic fat accumulation. Additionally, restricting the consumption of added sugars and fructose may be effective in preventing hepatic steatosis by suppressing lipogenesis processes.
In light of all these scientific findings, considering the impact of dietary patterns on the development and progression of MASLD, appropriately structuring the diet is critically important for protecting liver health in children. Accordingly, an anti-inflammatory, antioxidant, and metabolically balanced DASH dietary model is considered an effective and applicable approach in the management of pediatric MASLD.
Within the scope of this study, the effects of implementing the DASH diet in children with MASLD on clinical and metabolic parameters such as liver enzymes, degree of hepatic steatosis, insulin resistance, lipid profile, and inflammatory markers will be evaluated compared to a control group. Additionally, by examining the relationships between these parameters and quality of life as well as dietary adherence, the potential therapeutic role of the DASH diet in the management of pediatric MASLD will be elucidated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was designed as a randomized, parallel-assigned dietary intervention without blinding (open-label) because blinding the diets was impractical.
| Arm | Type | Receives |
|---|---|---|
| DASH Diet + Physical Activity | Active comparator | Other: DASH Diet, Other: Physical ActivityDASH Diet + Physical Activity The DASH diet is structured with a macronutrient distribution of 50-55% carbohydrates, 16-18% protein, and 27-30% fat. The diet plan includes high amounts of fruits, vegetables, low-fat dairy products, oilseeds, legumes, and whole grains, as well as low amounts of sodium, sugary foods, and red and processed meats. The goal is to increase physical activity with a home-based exercise program. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with a parent. Participants will be instructed to start the exercise with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step, dance, throwing a ball against a wall, running up and down stairs), and finish the exercise with 5 minutes of cool-down exercises (stretching). |
| Standard Diet + Physical Activity | Experimental | Other: Standart Diet, Other: Physical ActivityStandard Diet + Physical Activity The standard diet is planned so that 45-60% of energy comes from carbohydrates, 25-35% from fats, and 15-20% from proteins. The standard diet is based on the healthy eating recommendations for children in the Turkish Nutrition Guide (TÜBER) 2022 Nutrition Guide. Unlike the DASH diet, the standard diet allows the consumption of refined grains, full-fat milk and meat products, and simple sugars not exceeding 10% of energy. The goal is to increase physical activity with a home-based exercise program. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with parental guidance. Participants will be instructed to begin their workout with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step aerobics, dancing, throwing a ball against a wall, running up and down stairs), and conclude with 5 minutes of cool |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Eligibility criteria include being between 11 and 18 years of age,
- Having a body mass index (BMI) ≥95th percentile,
- Having hepatic steatosis detected by magnetic resonance imaging (MRI) and proton density fat fraction (PDFF) measurement (cutoff value ≥5%).
Key exclusion criteria (8 listed)
- Other liver diseases (such as viral hepatitis, autoimmune hepatitis, Wilson's disease),
- Alcohol consumption,
- History of type I or type II diabetes,
- Use of medications that may affect fatty liver or blood lipid profile (corticosteroids, metformin, vitamin E, omega-3 fatty acids, etc.),
- Having participated in a weight loss program or undergone bariatric surgery prior to the study,
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 |
|---|---|---|
| DASH DietThe DASH diet is structured with a macronutrient distribution of 50-55% carbohydrates, 16-18% protein, and 27-30% fat. The diet plan recommends high intake of fruits, vegetables, low-fat dairy products, oilseeds, legumes, and whole grains, as well as low intake of sodium, sugary foods, and red and processed meats. | Other | DASH Diet + Physical Activity |
| Standart DietThe standard diet is planned so that 45-60% of energy comes from carbohydrates, 25-35% from fats, and 15-20% from proteins. The standard diet is based on the healthy eating recommendations for children in the 2022 Turkish Nutrition Guide (TÜBER). Unlike the DASH diet, the standard diet allows the consumption of refined grains, full-fat milk and meat products, and simple sugars not exceeding 10% of energy. | Other | Standard Diet + Physical Activity |
| Physical ActivityThe home-based exercise program aims to increase physical activity. The exercise program is planned as 30 minutes x 5 days a week, under parental supervision or with parental guidance. Participants will be instructed to begin their workout with 10 minutes of warm-up exercises (push-ups, sit-ups, reverse sit-ups, squats, aerial cycling, stretching), continue with 15 minutes of aerobic activities (jump rope, step aerobics, dancing, throwing a ball against a wall, running up and down stairs), and conclude with 5 minutes of cool-down exercises (stretching). | Other | DASH Diet + Physical Activity, Standard Diet + Physical Activity |
Primary outcome
Change in hepatic steatosis percentage
Time frame: 12 weeks
Comparison of the change in hepatic steatosis percentage, as measured by MRI-PDFF, in diet groups over 12 weeks.
3 secondary outcomes
Changes in insulin resistance
Time frame: 12 weeks
Changes in anthropometric measurements
Time frame: 12 weeks
Changes in fibrosis index
Time frame: 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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. The study will present de-identified individual participant data collected during the trial, including demographic, anthropometric, dietary, and physical activity data, the study protocol, the statistical analysis plan, and the informed consent form.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Diet, Standart Diet and Physical Activity in people with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), run by Antalya Training and Research Hospital.
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 3 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ulas Emre Akbulut, Assoc. Prof. (+90 242 249 44 00, ulasemre@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic steatosis percentage (time frame: 12 weeks). 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 18 Mar 2026.