The Effect of the DASH Diet on Clinical and Metabolic Parameters in Children With MASLD

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 Overview

• Status: Not yet recruiting
• Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
• Intervention / Treatment: Other: DASH Diet; Other: Physical Activity; Other: Standart Diet

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ulas Emre Akbulut, Assoc. Prof.; Phone Number: +90 242 249 44 00; Email: ulasemre@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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%).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DASH Diet + Physical Activity; 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).	Other: DASH Diet; 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.; Other: Physical Activity; 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).
Experimental: Standard Diet + Physical Activity; 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	Other: Physical Activity; 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).; Other: Standart Diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hepatic steatosis percentage	Comparison of the change in hepatic steatosis percentage, as measured by MRI-PDFF, in diet groups over 12 weeks.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insulin resistance	The insulin resistance index will be calculated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) formula.	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).	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).	12 weeks

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: DASH Diet; MASLD; Diet modification
• Additional Relevant MeSH Terms: Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Exercise; Dietary Approaches To Stop Hypertension
• Other Study ID Numbers: Antalya Training and Research

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No