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Nutrition Intervention Combined With Resmetirom for MASH
Sponsor: City University of New York
Summary
This randomized control trial aims to evaluate the effectiveness of combining resmetirom therapy (first approved pharmacological therapy for treating metabolic dysfunction-associated steatohepatitis (MASH)) with a nutritional intervention compared to resmetirom therapy alone over one year in improving liver health among 120 patients living with non-cirrhotic MASH. We hypothesize that patients receiving resmetirom and nutritional intervention will experience more significant improvements in liver function than those receiving only resmetirom therapy.
Official title: Assessing Nutrition-aligned Resmetirom Roll-out
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10-01
Completion Date
2028-06-30
Last Updated
2026-07-02
Healthy Volunteers
No
Interventions
Resmetirom therapy
All participants involved in the study will receive treatment according to resemetirom protocol: For patients weighing: * \<100 kg, the recommended dosage is 80 mg orally, once daily * ≥100 kg, the recommended dosage is 100 mg orally, once daily
Comprehensive nutritional intervention
The nutritional intervention will consist of two components: 1. Medically tailored meals (MTMs): Participants will receive 10 MTMs per week delivered by God's Love We Deliver in New York City. Meals will follow Mediterranean diet principles (40% carbohydrate, 35-45% fat, 15-25% protein), be delivered frozen with preparation and safety instructions, and meal preferences will be collected in advance. Participants will be encouraged to eat two meals per weekday and source any additional food independently. 2. Nutritional and physical activity educational support: Online educational materials will be provided at baseline and follow-up visits, covering healthy eating, Mediterranean-diet principles, and exercise recommendations.
Standard dietary support
Participants will receive standard-of-care lifestyle recommendations, including handouts on healthy diet and physical activity, and the option of a telehealth consultation with a dietitian.
Locations (1)
CUNY Graduate School of Public Health and Health Policy
New York, New York, United States