RecruitingNot ApplicableNCT06990152

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

Sponsor

Dr. Schär AG / SPA

Enrollment

60 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Psoriatic Arthritis (PsA)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

Adult patients: aged 18-80 years;
Clinical diagnosis of PsA meeting the CASPAR classification criteria;
Low disease activity (4 < DAPSA ≤ 14) at the time of recruitment;
Under stable pharmacological treatment with disease-modifying antirheumatic drugs (DMARDs) (conventional synthetic, targeted synthetic, or biological);
Disease duration > 6 months;
Absence of metabolic diseases.

Exclusion Criteria10

BMI ≥ 27 kg/m²;
Current or desired pregnancies (confirmed by pregnancy test);
Disease activity in remission (DAPSA ≤ 4), moderate (14 < DAPSA ≤ 28), or high (DAPSA > 28) at the time of recruitment;
Pediatric onset of the disease (< 16 years);
Patients on a vegan, ketogenic, or MCT-rich diet (containing MCT in supplement form or high amounts of palm or coconut oil);
Presence of ketoacidosis/metabolic acidosis, decompensated liver cirrhosis, or medium-chain acyl-CoA dehydrogenase (MCAD) deficiency;
Type 2 diabetes, cardiovascular diseases, hypertension, ischemic diseases, renal failure, malignant tumors, respiratory diseases, dyslipidemia, fibromyalgia, metabolic syndrome;
Major depression;
Gastritis, esophagitis, reflux syndrome, chronic inflammatory bowel diseases (IBD);
Lactose intolerance.