NCT06990152

A Randomized, Double-blind Clinical Trial on the Efficacy of a Dietary Formulation Containing Medium-chain Triglycerides (MCT) and Fiber in Patients With Psoriatic Arthritis

Trial Clinico Randomizzato e Doppio-cieco Sull'Efficacia di Una Formulazione Alimentare Contenente Trigliceridi a Media Catena (MCT) e Fibre in Pazienti Con Artrite Psoriasica

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Dr. Schär AG / SPA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effects of a formulation containing medium-chain triglycerides (MCTs) and vegetable fibers on the quality of life of patients with psoriatic arthritis, by monitoring the patients over a period of 3 months in a single-center interventional study. As secondary objectives, the study will assess the effects of the same formulation on disease activity and on certain blood parameters and dietary habits.

Detailed description

The diagnostic and therapeutic framework in the field of psoriatic arthritis (PsA) is complex and not yet fully defined. Despite significant advances in pharmacological therapy and although particularly satisfactory results can be achieved thanks to new-generation DMARDs (disease-modifying antirheumatic drugs), there is still a significant gap regarding factors that, in addition to pharmacological therapy, could help patients further improve their health status, primarily dietary habits. The aim of this study is to evaluate the effectiveness of a special medical food based on MCTs and fiber in improving quantitative and qualitative parameters in patients with PsA under stable pharmacological treatment and with low disease activity. Specifically, this will be achieved through the analysis of health-related quality of life as perceived by patients, the impact of the disease on general life, body composition and sarcopenia, physical and mental health status of patients, dietary habits, and through an evaluation of metabolic and inflammatory blood parameters.

Conditions

• Psoriatic Arthritis (PsA)

Interventions

Type	Name	Description
OTHER	MCTs and fiber	Water-soluble powder containing medium-chain triglycerides, soluble and unsoluble fiber.
OTHER	Placebo powder	Water-soluble powder containing no medium-chain triglycerides and no fiber.

Timeline

• Start date: 2025-05-16
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-05-25
• Last updated: 2025-05-29

Locations

1 site across 1 country: Italy